Randomized phase III study of neoadjuvant chemotherapy followed by surgery vs. concomitant radiotherapy and chemotherapy in FIGO Ib2, IIa > 4 cm or IIb cervical cancer.

Phase 1

• Conditions: Cervical carcinoma (including squamous cell carcinoma, adenosquamous cell or adenocarcinoma; MedDRA version: 16.0Level: LLTClassification code 10008242Term: Cervical carcinoma stage IBSystem Organ Class: 100000004864; MedDRA version: 16.0Level: LLTClassification code 10008244Term: Cervical carcinoma stage IIASystem Organ Class: 100000004864; MedDRA version: 16.0Level: LLTClassification code 10008245Term: Cervical carcinoma stage IIBSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-003396-52-GB
• Lead Sponsor: European Organisation for Research and Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-01
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 686

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 528
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 51

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Overall surviva.<br>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);Secondary Objective: Progression free survival <br>Toxicity<br>Quality of life;Primary end point(s): Overall survival;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<br>the date of patient randomization to the date of death (any cause) or last seen;

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - progression-free survival<br>- toxicity<br>- quality of life;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.