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: 12.0Level: LLTClassification code 10008242Term: Cervical carcinoma stage IB; MedDRA version: 12.0Level: LLTClassification code 10008244Term: Cervical carcinoma stage IIA; MedDRA version: 12.0Level: LLTClassification code 10008245Term: Cervical carcinoma stage IIB

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-27
• Study Completion: 2019-11-29
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 626

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
- 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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: To demonstrate a survival advantage with the use of neoadjuvant chemotherapy followed by radical surgery as compared to the standard approach (concomitant chemitherapy and radiotherapy);Secondary Objective: Progression free survival <br>Toxicity<br>Quality of life;Primary end point(s): Overall survival