Efficacy and toxicity of concomitant chemoradiation with weekly gemcitabine/cisplatin in comparison with weekly cisplatin in cervical cancer: a phase II, randomised trial

Completed

• Conditions: Cervical cancer (FIGO stage IB, II , III, IVA); Cancer; Cervical cancer

• Registration Number: ISRCTN29976507
• Lead Sponsor: Shaheed Beheshti University of Medical Science (SBMU) (Iran)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-14
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1. Women with untreated locally advanced cervical cancer International Federation of Gynaecology and Obstetrics (FIGO) stage IB, II, III, IVA
2. Histologically confirmed Squamous Cell Carcinoma (SCC)
3. Aged between 18 - 70 years
4. Performance status less than or equal to 2 in Eastern Cooperative Oncology Group (ECOG) scale
5. No active co-morbid illness (uncontrolled infection, cardiopulmonary disease, uncontrolled diabetes mellitus)
6. Laboratory data at start of chemotherapy:
6.1. Haemoglobin (Hb) 12 g/dl or corrected to 11 g/dl before the start of therapy
6.2. Platelets (Plt) 100 x 10^9/L
6.3. Absolute Neutrophil Count (ANC) more than or equal to 1.5 x 10^9/L
6.4. Creatinine (Cr) less than or equal to 1.5 x Upper Limit of Normal (ULN)
6.5. Billirubin less than or equal to 1.5 ULN
6.6. Aspartate Aminotransferase (AST) less than or equal to 2 x ULN
6.7. Alanine Aminotransferase (ALT) less than or equal to 2 x

Exclusion Criteria

1. Any metastatic disease
2. Previous pelvic irradiation
3. History of other malignancy except non-melanoma skin cancer
4. Disease out of the pelvis and para-aortic lymph nodes

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Two year disease free survival (time from completion of chemoradiation to first pathologically documented local recurrence or distant metastasis out of pelvis).

Secondary Outcome Measures

Name	Time	Method
The following will be assessed at the end of patient accrual: <br>1. Clinical complete response rate (complete disappearance of tumor radiologically and clinically in the first evaluation after treatment) <br>2. Toxicity profile according to the World Health Organization (WHO) criteria<br>3. Overall survival (time from completion of chemoradiation to death)