Concurrent Chemoradiotherapy With Weekly Cisplatin Versus Concurrent Chemoradiotherapy With Weekly Cisplatin and Paclitaxel in Locally Advanced Carcinoma Cervix

Phase 3

• Conditions: Carcinoma Cervix
• Interventions: Drug: Paclitaxel, Cisplatin; Drug: Cisplatin

• Registration Number: NCT01593306
• Lead Sponsor: Indira Gandhi Medical College, Shimla

Brief Summary

The purpose of this study is to check whether addition of paclitaxel to cisplatin and radiation therapy will improve the outcome in locally advanced carcinoma cervix.

Detailed Description

Carcinoma cervix is the 2nd most common malignancy among females and about 86% of this burden occurs in developing countries. India accounts for 27% of world cervical cancer burden; and most of them are of locally advanced stage ie stage IIA to IVA.

Significant development in radiation techniques and addition of cisplatin based chemotherapy to radiation schedule has led to improved survival but still it is far from satisfactory with 20 to 25% patients failing locally while 10 to 20% patients fail at distant sites. Novel techniques are required to improve this dismal rate.

Thus investigators intended to use combination chemotherapy with paclitaxel and cisplatin, considering that paclitaxel is a taxane which has shown good efficacy in other solid tumors such as ovary, lung and breast; it has also shown radiosensitizing effect in cervical cancer cell lines and it has also been shown to be effective in phase III trials with cisplatin in metastatic and recurrent carcinoma cervix.

Study Timeline

• Study Start: 2011-07
• Status Verified: 2012-05
• Study First Submitted: 2012-05-03
• Study First Submitted QC: 2012-05-07
• Last Update Submitted: 2012-05-07
• Study First Posted: 2012-05-08
• Last Update Posted: 2012-05-08
• Primary Completion: 2012-10
• Study Completion: 2013-02

Recruitment & Eligibility

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

Inclusion Criteria

• histologically proven carcinoma cervix
• age 18 years to 65 years
• stage IIA, IIB, IIIA & IIIB according to FIGO 2009

Exclusion Criteria

• age > 65 years and < 18 years
• stage IA, IB, IVA & IVB
• Histology other than squamous cell, adenocarcinoma or adenosquamous carcinoma
• history of prior pelvic surgery for cancer, prior pelvic radiotherapy or prior chemotherapy.
• deranged renal function test and liver function test
• KPS >= 60
• distant metastasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cisplatin and paclitaxel with concurrent radiotherapy	Paclitaxel, Cisplatin	weekly cisplatin at 30mg/m2 and paclitaxel at 50mg/m2 are given with concurrent radiotherapy at 2Gy per fraction at 5 fractions per week for 5 weeks followed by either low dose rate (LDR) Intracavitary (I/C) Brachytherapy or supplement Chemoradiotherapy (CRT); if not fit for I/C Brachytherapy
cisplatin with concurrent radiotherapy	Cisplatin	weekly cisplatin @ 40mg/m2 is given along with concurrent radiotherapy at 2Gy per fraction with 5 fractions per week for 5 weeks followed by LDR I/C brachytherapy or supplement CRT; if not fit for I/C Brachytherapy

Primary Outcome Measures

Name	Time	Method
clinical response of the disease	up to 1 year	to compare clinically, the disease response and local control of combination chemotherapy with weekly cisplatin and paclitaxel with concurrent Radiotherapy Vs single agent cisplatin with concurrent Radiotherapy in locally advanced carcinoma cervix

Secondary Outcome Measures

Name	Time	Method
number of patients with adverse events	during treatment, 14 weeks	to monitor number of treatment related adverse events in both the arms

Trial Locations

Locations (1)

Indira Gandhi Medical College; 🇮🇳 Shimla, Himachal Pradesh, India