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

Indira Gandhi Medical College, Shimla

Status and phase: Unknown; Phase 3

Conditions: Carcinoma Cervix

Treatments: Drug: Paclitaxel, Cisplatin; Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01593306

pragyat1805

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

cisplatin and paclitaxel with concurrent radiotherapy

Experimental group

Description:

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

Treatment:

Drug: Paclitaxel, Cisplatin

cisplatin with concurrent radiotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Cisplatin