E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Women between 18 en 40 years with histologically confirmed invasive cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 IB2 measuring >2cm to ≤4cm |
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E.1.1.1 | Medical condition in easily understood language |
woman between the age of 18 and 40 years with cervical cancer with a tumor size between >2 and ≤4 cm |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the feasibility of preserving fertility in women with node negative, 2018 FIGO stage IB2 cervical cancer with lesions measuring >2cm - ≤4cm by administering neo-adjuvant chemotherapy (NACT) followed by fertility sparing surgery (FSS) and no adjuvant therapy |
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E.2.2 | Secondary objectives of the trial |
To evaluate the response rate based on RECIST 1.1 following neoadjuvant chemotherapy for patients with node negative stage FIGO 2018 IB2 cervical cancer; To evaluate the safety of the fertility sparing surgery (FSS) in women with node negative, FIGO 2018 stage IB2 cervical cancer measuring >2cm - ≤4cm To evaluate overall survival (OS) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients must have histologically confirmed invasive cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 IB2 measuring >2cm to ≤4cm
Patients must be ≥18 years of age, and < 40 years of age
Patients must be premenopausal and wish to preserve fertility
no prior therapy to treat their cancer lesion, patients with diagnostic cone or LEEP are allowed but a measurable tumor of >2 cm - ≤4 cm is mandatory
Eastern Cooperative Group (ECOG) performance status ≤ 2
Within 7 days of the proposed start of treatment, patients must have normal organ and marrow function
No evidence of active uncontrolled infection
Patient must have disease that is measurable per RECIST 1.1.
Ability to understand and willing to sign a written informed consent document.
A negative serum pregnancy test
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E.4 | Principal exclusion criteria |
Patients who have had chemotherapy or radiotherapy or surgery for their cancer. Patients with diagnostic cone or LEEP are allowed
Patients who are receiving any other investigational agents.
Patients with other cancers requiring ongoing treatment.
Patients with known / evidence of brain metastases
History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, carboplatin, or cisplatin or other agents used in study.
Uncontrolled inter-current illness
Patients who are pregnant or breastfeeding
Any other condition that would, in the Investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues.
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E.5 End points |
E.5.1 | Primary end point(s) |
to determine the rate of functional uterus defined as successful fertility sparing surgery (FSS) with no adjuvant therapy |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
response rate based on RECIST 1.1 following neoadjuvant chemotherapy safety of the fertility sparing surgery (FSS) overall survival (OS) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
response rate based on RECIST 1.1 following neoadjuvant chemotherapy safety of the fertility sparing surgery (FSS) measured as two and three-year recurrence free survival overall survival (OS): up to two and three years |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |