A randomised phase III trial of preoperative chemoradiation versus chemoradiation with weekly cisplatin/gemcitabine in FIGO stages IB2-IIB

Phase 3

Completed

• Conditions: Cancer; Cervical carcinoma; Cervical

• Registration Number: ISRCTN88773338
• Lead Sponsor: ational Cancer Institute of Mexico (Instituto Nacional de Cancerologia)

Brief Summary

2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23609186 (added 03/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-06
• Study Completion: 2006-12-31
• Last Update Posted: 27 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 211

Inclusion Criteria

1. Histologically confirmed squamous, adenosquamous or adenocarcinoma
2. Untreated
3. International Federation of Gynecology and Obstetrics (FIGO) staged IB2, IIA and IIB
4. Mesurable disease
5. Aged 18 to 70 years
6. Zero to two World Health Organisation (WHO) status performance
7. Normal renal, hepatic and hematological function
8. Negative pregnancy test or biological inability to become pregnant
9. Informed consent

Exclusion Criteria

1. Systemic and/or uncontrolled disease that preclude the use of chemotherapy
2. Pre-existent or concurrent neuropathy of any cause
3. Mental disease
4. Previous malignancy except non-melanoma skin cancer

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy in terms of overall and progression free-survival

Secondary Outcome Measures

Name	Time	Method
Toxicity of chemoradiation and early and late complications the surgical treatment.