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    Clinical Trial Results:
    Phase II trial of weekly Carboplatin-Paclitaxel adjuvant chemotherapy after intensity modulated extended-field chemoradiation in the treatment of locally advanced cervical cancer with para-aortic positive nodes

    Summary
    EudraCT number
    2018-001752-35
    Trial protocol
    FR  
    Global end of trial date
    20 Jun 2025

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Feb 2026
    First version publication date
    28 Feb 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2018-06
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04016142
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Centre Oscar Lambret
    Sponsor organisation address
    3 Rue Frédéric Combemale, Lille, France, 59000
    Public contact
    DRCI Sponsor Unit, Centre Oscar Lambret, +33 320295918, promotion@o-lambret.fr
    Scientific contact
    DRCI Sponsor Unit, Centre Oscar Lambret, +33 320295918, promotion@o-lambret.fr
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Nov 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jan 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jun 2025
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of adjuvant chemotherapy per Carboplatin-Paclitaxel administrated in adjuvant situation after concomitant radio-chemotherapy in terms of Progression Free Survival (PFS) for patients treated for a cervical cancer locally advanced presenting positive lombo-aortic lymph nodes
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles of the 1964 Helsinki declaration, revised in 2013 and 2024 in Fortaleza, with the rules of Good Clinical Practice (GCP) defined by the International Conference on Harmonization (ICH-E6, 17/7/96)), and all applicable laws et regulations. The clinical trial did not begin before approval of the Ethics Committees and authorization by competent authorities concerned.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Jun 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 21
    Worldwide total number of subjects
    21
    EEA total number of subjects
    21
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    18
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The trial was opened in 6 french centers. 21 patients were enrolled in 2 centers from 15/06/2020 and 04/07/2023 in the part I of the study. Among these patients, 14 patients were enrolled in the part II of the study.

    Pre-assignment
    Screening details
    A total of 45 patients were planned in the study protocol, but only 21 patients were actually enrolled due to low recruitment.

    Period 1
    Period 1 title
    Part 1: standard concomitant RT-CT
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Population included in part I
    Arm description
    Standard treatment
    Arm type
    First part of the study (standard treatment)

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intravenous use
    Dosage and administration details
    Weekly cisplatin (40 mg/m²)

    Number of subjects in period 1
    Population included in part I
    Started
    21
    Completed
    14
    Not completed
    7
         Patient refusal
    2
         Standard treatment not received in totality
    1
         Adverse event, non-fatal
    3
         Progression
    1
    Period 2
    Period 2 title
    Part 2: experimental adjuvant CT
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Population included in part II
    Arm description
    Experimental treatment
    Arm type
    Second part of the study (experimental treatment)

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    80 mg/m² (+/- 5% tolerated) Maximum dose = 160mg (corresponding to a BSA = 2.0m²)

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    AUC2 * (GFR + 25) mg (+/- 5% tolerated) Maximum dose = 270 mg (corresponding to a GFR of 110ml/min)

    Number of subjects in period 2
    Population included in part II
    Started
    14
    Completed
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1: standard concomitant RT-CT
    Reporting group description
    -

    Reporting group values
    Part 1: standard concomitant RT-CT Total
    Number of subjects
    21 21
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    18 18
        From 65-84 years
    3 3
        85 years and over
    0 0
    Age continuous
    Units: years
        median (full range (min-max))
    52 (25 to 77) -
    Gender categorical
    Units: Subjects
        Female
    21 21
        Male
    0 0

    End points

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    End points reporting groups
    Reporting group title
    Population included in part I
    Reporting group description
    Standard treatment
    Reporting group title
    Population included in part II
    Reporting group description
    Experimental treatment

    Primary: PFS (progression-free survival)

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    End point title
    PFS (progression-free survival) [1]
    End point description
    End point type
    Primary
    End point timeframe
    PFS is estimated from the date of inclusion in the part II of the trial to the date of first progression or relapse (local, lymph nodes or metastatic) or death whatever the cause. Patients alive without progression at the date of last news are censored
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The study was prematurely ended due to lack of recrtuitment. No formal statistical comparison has been performed.
    End point values
    Population included in part II
    Number of subjects analysed
    14
    Units: 2-years PFS rate in %
        number (confidence interval 95%)
    71.4 (40.6 to 88.2)
    No statistical analyses for this end point

    Secondary: OS (overall survival)

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    End point title
    OS (overall survival)
    End point description
    End point type
    Secondary
    End point timeframe
    OS is estimated from the date of inclusion in the part II of the trial to the date of death whatever the cause. Patients alive at the date of last news are censored
    End point values
    Population included in part II
    Number of subjects analysed
    14
    Units: 2-years OS rate in %
        number (confidence interval 95%)
    91.7 (53.9 to 98.8)
    No statistical analyses for this end point

    Secondary: MFS (metastatic-free survival)

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    End point title
    MFS (metastatic-free survival)
    End point description
    End point type
    Secondary
    End point timeframe
    MFS is estimated from the date of inclusion in the part II until the date of first metastatic progression or death whatever the cause. Patients alive without metastatic progression at the date of last news are censored at this date
    End point values
    Population included in part II
    Number of subjects analysed
    14
    Units: 2-years MFS rate in %
        number (confidence interval 95%)
    78.6 (47.2 to 92.5)
    No statistical analyses for this end point

    Secondary: Feasability

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    End point title
    Feasability
    End point description
    The number of cycles will be recorded
    End point type
    Secondary
    End point timeframe
    During the experimental treatment
    End point values
    Population included in part II
    Number of subjects analysed
    14
    Units: Number of chemotherapy cycles started
    14
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For the 2nd part of the study, all AE are reported up to 30 days after the end of adjuvant chemotherapy, until progression if any. Then, only AE possibly related to chemotherapy or radiation therapy are collected, up to 5 years after end of RT
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Adverse events
    Reporting group description
    -

    Serious adverse events
    Adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 14 (7.14%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Immune system disorders
    Anaphylactic reaction
    Additional description: Anaphylactic reaction
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 14 (100.00%)
    Vascular disorders
    Hot flush
    Additional description: Hot flush
         subjects affected / exposed
    4 / 14 (28.57%)
         occurrences all number
    7
    Lymphoedema
    Additional description: Lymphoedema
         subjects affected / exposed
    4 / 14 (28.57%)
         occurrences all number
    5
    Surgical and medical procedures
    Glaucoma surgery
    Additional description: Glaucoma surgery
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
    Additional description: Asthenia
         subjects affected / exposed
    11 / 14 (78.57%)
         occurrences all number
    25
    Mucosal inflammation
    Additional description: Mucosal inflammation
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Oedema peripheral
    Additional description: Oedema peripheral
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    3
    Reproductive system and breast disorders
    Breast haematoma
    Additional description: Breast haematoma
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Dyspareunia
    Additional description: Dyspareunia
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Intermenstrual bleeding
    Additional description: Intermenstrual bleeding
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Menopausal symptoms
    Additional description: Menopausal symptoms
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Pelvic pain
    Additional description: Pelvic pain
         subjects affected / exposed
    4 / 14 (28.57%)
         occurrences all number
    4
    Rectocele
    Additional description: Rectocele
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Uterine fibrosis
    Additional description: Uterine fibrosis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Vaginal discharge
    Additional description: Vaginal discharge
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    4
    Vaginal haemorrhage
    Additional description: Vaginal haemorrhage
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Vulvovaginal dryness
    Additional description: Vulvovaginal dryness
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Vulvovaginal swelling
    Additional description: Vulvovaginal swelling
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
    Additional description: Cough
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    4
    Psychiatric disorders
    Sleep disorder
    Additional description: Sleep disorder
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Investigations
    Blood folate decreased
    Additional description: Blood folate decreased
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Eosinophil count increased
    Additional description: Eosinophil count increased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Transaminases increased
    Additional description: Transaminases increased
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    3
    Injury, poisoning and procedural complications
    Compression fracture
    Additional description: Compression fracture
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Contusion
    Additional description: Contusion
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Face injury
    Additional description: Face injury
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Fracture
    Additional description: Fracture
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Pelvic fibrosis
    Additional description: Pelvic fibrosis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Dysgeusia
    Additional description: Dysgeusia
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Headache
    Additional description: Headache
         subjects affected / exposed
    4 / 14 (28.57%)
         occurrences all number
    4
    Hypoaesthesia
    Additional description: Hypoaesthesia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Neuropathy peripheral
    Additional description: Neuropathy peripheral
         subjects affected / exposed
    11 / 14 (78.57%)
         occurrences all number
    25
    Paraesthesia
    Additional description: Paraesthesia
         subjects affected / exposed
    5 / 14 (35.71%)
         occurrences all number
    5
    Sciatica
    Additional description: Sciatica
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Syncope
    Additional description: Syncope
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Taste disorder
    Additional description: Taste disorder
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Uraemic neuropathy
    Additional description: Uraemic neuropathy
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    13 / 14 (92.86%)
         occurrences all number
    37
    Hyperleukocytosis
    Additional description: Hyperleukocytosis
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Lymphopenia
    Additional description: Lymphopenia
         subjects affected / exposed
    12 / 14 (85.71%)
         occurrences all number
    24
    Neutropenia
    Additional description: Neutropenia
         subjects affected / exposed
    7 / 14 (50.00%)
         occurrences all number
    16
    Thrombocytopenia
    Additional description: Thrombocytopenia
         subjects affected / exposed
    8 / 14 (57.14%)
         occurrences all number
    11
    Ear and labyrinth disorders
    Deafness
    Additional description: Deafness
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Hypoacusis
    Additional description: Hypoacusis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Tinnitus
    Additional description: Tinnitus
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Eye disorders
    Vision blurred
    Additional description: Vision blurred
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Visual field defect
    Additional description: Visual field defect
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal distension
    Additional description: Abdominal distension
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Anal incontinence
    Additional description: Anal incontinence
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Burn oesophageal
    Additional description: Burn oesophageal
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    5 / 14 (35.71%)
         occurrences all number
    6
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    10 / 14 (71.43%)
         occurrences all number
    16
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    5 / 14 (35.71%)
         occurrences all number
    11
    Flatulence
    Additional description: Flatulence
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Gastrooesophageal reflux disease
    Additional description: Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    2
    Haemorrhoids
    Additional description: Haemorrhoids
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    7 / 14 (50.00%)
         occurrences all number
    22
    Odynophagia
    Additional description: Odynophagia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    5 / 14 (35.71%)
         occurrences all number
    11
    Proctitis
    Additional description: Proctitis
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Toothache
    Additional description: Toothache
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Alopecia
    Additional description: Alopecia
         subjects affected / exposed
    7 / 14 (50.00%)
         occurrences all number
    8
    Dry skin
    Additional description: Dry skin
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Pain of skin
    Additional description: Pain of skin
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Telangiectasia
    Additional description: Telangiectasia
         subjects affected / exposed
    6 / 14 (42.86%)
         occurrences all number
    6
    Renal and urinary disorders
    Dysuria
    Additional description: Dysuria
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Incontinence
    Additional description: Incontinence
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    2
    Nocturia
    Additional description: Nocturia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Urinary incontinence
    Additional description: Urinary incontinence
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Arthralgia
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    4
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    4
    Muscle spasms
    Additional description: Muscle spasms
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Myalgia
    Additional description: Myalgia
         subjects affected / exposed
    6 / 14 (42.86%)
         occurrences all number
    6
    Neck pain
    Additional description: Neck pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Pain in extremity
    Additional description: Pain in extremity
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Infections and infestations
    Covid-19
    Additional description: Covid-19
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Cystitis
    Additional description: Cystitis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Gastroenteritis
    Additional description: Gastroenteritis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Genital infection
    Additional description: Genital infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Nasopharyngitis
    Additional description: Nasopharyngitis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Cell death
    Additional description: Cell death
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Decreased appetite
    Additional description: Decreased appetite
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Hypoglycaemia
    Additional description: Hypoglycaemia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Iron deficiency
    Additional description: Iron deficiency
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Mar 2020
    Protocol, and synopsis: •Modification of the delay between the baseline assessments and inclusion in Part 1, going from 7 days to 28 days. The biological assessment must be carried out within 7 days before the start of treatment. •Modification of gynecological monitoring: it will not be requested at each visit during the treatment cycles: these examinations must be carried out at baseline, before the start of Part 2 and at the end of the study (at the end of treatment) and when necessary •Pregnancy tests: this test remains necessary at baseline for validation of inclusion, it will then no longer be carried out automatically and mandatory at other times of the study, because the sterilizing effect of radiotherapy is recognized. •Modification of an inclusion criterion for Part 2: “Patients who received chemotherapy + concomitant boost on macroscopic lymph nodes” modified by “Patients who received chemotherapy that can be associated with a concomitant boost on macroscopic lymph nodes.” » Because not all patients will receive this boost since it depends on the presence or not of lymph nodes visible macroscopically on the PET scan. •Concomitant treatments: it is added that treatment with EPO is not recommended. •Modification of an inclusion criterion for Part 2: “Patients who received chemotherapy + concomitant boost on macroscopic lymph nodes” is replaced by “Patients who received chemotherapy that can be associated with a concomitant boost on macroscopic lymph nodes.” », because not all patients will receive this boost since it depends on the presence or not of lymph nodes visible macroscopically on the PET scan •Concomitant treatments: it is added that treatment with EPO is not recommended. Trial site list: •Declaration of 3 new investigators for site n°1 (Centre Oscar Lambret, Lille) Informed consent form: •Conduct of the study: modification of the duration of the assessment planned for inclusion in Part 1, going from 7 days
    27 Mar 2020
    • Temporary halt of inclusions on 27-MAR-2020 due to the health situation linked to Covid-19 • Restart of inclusions on 26-MAY-2020 in the conditions prior to the transitional measures linked to Covid-19
    23 Feb 2021
    Trial site list: • Declaration of a new investigator for site n°1 (Centre Oscar Lambret, Lille) • Addition of a 6th trial site: Lens Hospital Center, represented by Dr. FOURQUET as principal investigator
    14 Jun 2021
    Protocol, and synopsis: • Addition of recommendations linked to the anti-COVID vaccine strategy Trial site lists: •Declaration of a new investigator for site n°2 (Centre Léonard de Vinci) SmPC PACLITAXEL 6mg/ml: •Update of the document (version of 14-JUNE-2021), with the description of a new adverse event of undetermined frequency: palmoplantar erythrodysesthesia which may persist beyond 6 months after stopping treatment. This modification has an impact on the expected/unexpected nature of the SARs and the conduct of the study; it is therefore considered substantial but does not require an update of the protocol (this already specifies the action to be taken in the event of peripheral neuropathies) nor the informed consent form given to patients (which already includes the list of frequent and very frequent adverse effects)
    21 Nov 2022
    Protocol, and synopsis: •Extension of the recruitment period by 6 months and update of the study schedule. The duration of exposure to the investigational drug is not extended, the definition of the end of the trial and the monitoring conditions are unchanged. At the end of this extension, the study will be definitively closed to recruitment. Protocol: •Compliance of the protocol with the SPC of paclitaxel dated 04-MAR-2021: addition of new contraindicated combinations with paclitaxel Informed consent form: •Information on the recruitment period is deleted because it is calculated on the total number of patients initially expected, however, the objective is now to reach 50% of inclusions (23 patients) by 30-JUNE-2023. •Information on the delay necessary to obtain results is also removed, for the same reasons as above. •Addition of a safety instruction related to the contraceptive method. •Addition of a paragraph to allow the reuse of data for other research (retrospective cohorts, etc.) •Update of the CNIL URL to allow patients to send a complaint to the CNIL; the postal address is also specified SmPC PACLITAXEL 6mg/ml •Update of the document (version of 04-MAR-2021). Some of the modifications have an impact on the list of concomitant treatments to avoid •Addition of contraindicated combinations of palitaxel with St. John's wort, live attenuated vaccines; •Addition of associations not recommended with new enzyme inducers not described in the previous version of the SPC) and fosphenytoin).
    20 Jun 2025
    Protocol and synopsis: •The follow-up of patients is interrupted on 31-JAN-2025 (=LPLV) •Addition of a paragraph regarding the modification of the end of the trial, and its justification •Compliance of the duration of follow-up with the end of the study New document: •Introduction of a new letter to inform patients of the end of the study Insurance: •The insurance certificate is updated following the new definition of end of study Note: This substantial amendment was released for information to regulatory authorities since the trial had already been completed, and because the platform for submitting amendments to the french Ethics Committee (SI RIPH 2G) does not allow to submit amendment after the end of the study. However, the Ethics Committee received and examined the documents outside the usual procedure and made a comment on the information letter. All modifications requested by the Ethics Committee regarding the information letter have been made.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    27 Mar 2020
    Temporary discontinuation (Covid), then permanent discontinuation because recruitment targets were very difficult to achieve with only two active sites (four of the six sites opened did not include any patients).
    26 May 2020

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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