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    Summary
    EudraCT Number:2018-000542-20
    Sponsor's Protocol Code Number:UC-0103/1802
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2018-000542-20
    A.3Full title of the trial
    Randomized phase III study of oral cyclophosphamide vs doxorubicin in 65 years or older patients with advanced or metastatic soft tissue sarcoma: a UNICANCER/GERICO multicenter program
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized phase III study of oral cyclophosphamide vs doxorubicin in 65 years or older patients with advanced or metastatic soft tissue sarcoma: a UNICANCER/GERICO multicenter program
    A.3.2Name or abbreviated title of the trial where available
    GERICO 14
    A.4.1Sponsor's protocol code numberUC-0103/1802
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUNICANCER
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointMeryem BRIHOUM
    B.5.3 Address:
    B.5.3.1Street Address101 rue de Tolbiac
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number33180 50 12 95
    B.5.5Fax number33185 34 33 79
    B.5.6E-mailm-brihoum@unicancer.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Endoxan
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCyclophosphamide
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50-18-0
    D.3.9.4EV Substance CodeSUB06859MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDoxorubicin
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOXORUBICIN
    D.3.9.1CAS number 23214-92-8
    D.3.9.4EV Substance CodeSUB06391MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced or metastatic soft tissue sarcoma (STS) in patients ≥65 years old.
    E.1.1.1Medical condition in easily understood language
    Advanced or metastatic soft tissue sarcoma (STS) in patients ≥65 years old.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to investigate whether treatment with oral cyclophosphamide improves the outcome of elderly patients (≥65 years old) with
    advanced/metastatic STS, compared with doxorubicin in term of PFS.
    E.2.2Secondary objectives of the trial
    Comparison of oral cyclophosphamide versus doxorubicin in terms of additional efficacy endpoints:
    Overall survival (OS);
    Best response under treatment;
    Time until definitive deterioration (TUDD) of health-related quality of life (HRQoL);
    Assessment of the toxicity profile of oral cyclophosphamide and doxorubicin, as per NCI CTCAE v5.0.
    Assessment of the prognostic value on efficacy (PFS, OS)
    Assessment of the geriatric characteristics of the randomized population,
    Assessment of compliance to oral metronomic cyclophosphamide (arm B only)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trust person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent
    2. Age ≥65 years (inclusions will be managed to ensure that at least 50% of the randomized patients are ≥75 years old)
    3. Diagnosis of soft-tissue sarcoma histologically confirmed by RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères)
    4. Metastatic or locally advanced disease not amenable to surgery, radiation, or combined modality treatment with curative intent. Palliative radiation therapy is permitted only if direct on nontarget lesion
    5. Documentation of disease progression within the last 6 months before randomization
    6. Measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT-scan as defined by response evaluation criteria in solid tumors (RECIST) v1.1
    7. Life expectancy of at least 6 months
    8. Eastern Cooperative Oncology Group (ECOG) performance status ≤2
    9. G8 score >14
    10. Left ventricular ejection fraction (LVEF) value by echocardiogram or Multiple gated acquisition scanning (MUGA) ≥55%
    11. Adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation:
    a. Absolute neutrophil count (ANC) ≥1,000/mm3
    b. Platelets ≥100,000/mm3
    c. Hemoglobin ≥9.0 g/dL
    d. Serum creatinine ≤2 x upper limit of normal (ULN)
    e. Glomerular filtration rate (GFR) ≥50 ml/min/1.73m2 (calculated with MDRD)
    f. AST and ALT ≤2.5 x ULN (≤5.0 × ULN for patients with liver involvement of their cancer )
    g. Total bilirubin ≤1.5 X ULN
    h. Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN with liver involvement of their cancer)
    i. serum albumin > 25 g/L
    j. Prothrombin time (PT)/International normalized ratio (INR) ≤1.5 x ULN
    Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until PT/INR is stable based on a measurement that is pre-dose as defined by the local standard of care.
    12. Male patients must agree to use adequate contraception for the duration of trial participation and up to 6 months after completing treatment/therapy. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care
    13. Patients must be affiliated to a Social Security System (or equivalent)
    14. Patient is willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures including follow-up
    E.4Principal exclusion criteria
    1. Previous systemic treatment for advance or metastatic sarcoma
    2. Previous neoadjuvant or adjuvant anthracycline treatment for localized sarcoma
    3. Soft-tissue sarcoma with the following histological subtypes: dermatofibrosarcoma protuberans, desmoid tumor, alveolar or embryonal rhabdomyosarcoma, Desmoplastic small round cell tumor, Kaposi Sarcoma, Gastro-Intestinal stromal tumor, Peripheral neuroectodermal tumors
    4. Primary bone sarcoma (including osteosarcoma, Ewing tumor, chondrosarcoma, and chordoma)
    5. Symptomatic or known central nervous system (CNS) metastases
    6. Known history of or concomitant malignancy likely to affect life expectancy in the judgment of the investigator and history of radiotherapy mediastinal in the last five years
    7. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before Day 1 of treatment
    8. Active cardio vascular disease including any of the following: Congestive heart failure (New York Heart Association [NYHA] ≥Class 2), unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), acute inflammatory cardiopathy, severe arythmia, high risk of bleeding, cerebrovascular accident within the last 6 months
    9. Uncontrolled grade >2 hypertension. (Systolic blood pressure ≥160 mmHg or diastolic pressure ≥100 mmHg despite optimal medical management)
    10. Ongoing infection ≥Grade 2 according to NCI Common Terminology Criteria for Adverse Events version (CTCAE v. 5.0)
    11. Known history of human immunodeficiency virus (HIV) infection
    12. Known history of chronic hepatitis B or C
    13. History of organ allograft
    14. Pre-existing acute hemorrhagic cystitis, urinary tract obstruction, acute urinary tract infection
    15. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
    16. Substance abuse, medical condition, that may interfere with the patient's participation in the study or evaluation of the study results
    17. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
    18. Inability to swallow oral medications, any malabsorption condition.
    19. Persons deprived of their liberty or under protective custody or guardianship
    20. Participation in another therapeutic trial within the 30 days prior to randomization and during the study
    21. Patients having received live attenuated vaccine therapy used for prevention of diseases as influenza, chickenpox, zoster, measles, mumps, rubella, tuberculosis, rotavirus or yellow fever within 4 weeks of the first dose of study drug. These vaccinations are not permitted during the study up to 6 months after the last treatment
    22. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is progression-free survival (PFS).
    PFS is defined as the time interval between the date of randomization and the date of progression (according to RECIST v1.1) or death, whichever occurs first.
    E.5.1.1Timepoint(s) of evaluation of this end point
    -
    E.5.2Secondary end point(s)
    Efficacy:
    OS is defined as the time interval between the date of randomization and the date of
    death of any cause.
    Best response under treatment: Best response (as per RECIST v1.1) recorded from the date of randomization until the end of treatment. Each patient will be assigned one of the following categories: complete response, partial response, stable disease, disease progression, or unevaluable for response (specify reasons, e.g. early death, malignant disease; toxicity; tumor assessment not repeated/incomplete; other). Responses will have to be confirmed at least 4 weeks after the evaluation to exclude measurement errors.
    Time until definitive deterioration (TUDD) of Health-related quality of life (HRQoL) is defined as the time interval between the date of randomization and the date of first deterioration of at least 10 points of the HRQoL score compared to baseline score, without any subsequent improvement as detailed further in Bonnetain et al.
    HRQoL will be assessed through European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire - Core 30 (QLQ-C30) and Quality of life questionnaire – Elderly cancer patients (QLQ-ELD14).
    The QLQ-C30 includes one global health status/quality of life (QoL) scale, five functional scales and three symptom scales. Each scale is scored from 0 to 100. A difference of 10 points or more in a scale indicates a minimal clinically important change.
    The QLQ-ELD14 includes 5 sub-scales and 2 isolated items. A difference of 10 points or more in a scale indicates a minimal clinically important change.
    HRQoL will be described at various time points and a longitudinal analysis will be conducted.
    Toxicity: Adverse events will be graded according to the CTCAE v5.0.
    Identification of prognostic factors of PFS and OS.
    Geriatric condition. Based on the recent work of the DIALOG task force for definition of GCODE for clinical oncology research, geriatric data will be collected as follows :
    1. Social environment: 2 questions
    - “Do you live alone?” Y/N
    - “Do you have any person able to provide you care and support?” Y/N
    2. Functional status: ADL and 4-IADL
    3. Mobility: Time Get Up and Go test (TUG)
    4. Nutritional Status: Weight loss during the last 6 months and BMI. If one of the test is abnormal, the nutritional status is considered impaired.
    - Weight loss during the last 6 months.
    - BMI = weight (kg) / height² (m).
    5. Cognitive status: Mini-Cog
    6. Depressive mood: Mini-GDS
    7. Comorbidities: Updated Charlson Comorbidity Index (updated CCI) (maximum=24).
    Compliance to oral metronomic cyclophosphamide (arm B only): compliance will be assessed based on data reported by the patients (patient diary).
    E.5.2.1Timepoint(s) of evaluation of this end point
    -
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned21
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 214
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state214
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    If the trial treatment is discontinued by a patient, further treatment will be at the investigator’s discretion as per standard of care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-07
    P. End of Trial
    P.End of Trial StatusOngoing
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