E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cervical carcinoma (including squamous cell carcinoma, adenosquamous cell or adenocarcinoma |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008242 |
E.1.2 | Term | Cervical carcinoma stage IB |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008244 |
E.1.2 | Term | Cervical carcinoma stage IIA |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008245 |
E.1.2 | Term | Cervical carcinoma stage IIB |
E.1.2 | System Organ Class | 100000004864 |
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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 |
Overall surviva.
To demonstrate a survival advantage with the use of neoadjuvant chemotherapy followed by radical surgery as compared to the standard approach (concomitant chemotherapy and radiotherapy) |
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E.2.2 | Secondary objectives of the trial |
Progression free survival
Toxicity
Quality of life |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Cervical carcinoma of following histological types: squamous cell carcinoma, adenosquamous cell or adenocarcinoma
- FIGO stage Ib2, IIa >4cm or IIb
- WHO performance status of 0-2
- 18 - 75 years
- No prior irradiation or chemotherapy
- No previous or concurrent second malignanct except for adequately treated basal cell carcinoma of the skin
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (those conditions should be discussed with the patient)
- not pregnant
- ANC > 1.5 x 109/l, platelets > 100 x 109/l, bilirubin < 25 µmol/l or < 1.46 mg/dl, creatinine clearance (calculated or measured) > 60 ml/min
- Before patient randomization, written informed consent must be given according to ICH/GCP and national/local regulations.
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E.4 | Principal exclusion criteria |
- Small cell, clear cell and other rare variants of the classical adenocarcinoma
- prior irradiation or chemotherapy
- previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin
- any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (those conditions should be discussed with the patient before registration in the trial)
- pregnant
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The main endpoint of the study is the duration of overall survival (OS) and will be computed from
the date of patient randomization to the date of death (any cause) or last seen; |
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E.5.2 | Secondary end point(s) |
- progression-free survival
- toxicity
- quality of life |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Progression-free survival (PFS), as a secondary end-point, is computed from the date of randomization to that of first report of disease progression or the date of death, whichever occurs. |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 |
Argentina |
Austria |
Belgium |
France |
Germany |
Ireland |
Netherlands |
Norway |
Poland |
Portugal |
Spain |
United Kingdom |
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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 | 17 |
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 | 17 |
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 |