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Concurrent Chemoradiotherapy With Weekly Cisplatin Versus Concurrent Chemoradiotherapy With Weekly Cisplatin and Paclitaxel in Locally Advanced Carcinoma Cervix
Conditions
Carcinoma Cervix
Conditions: official terms
Uterine Cervical Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: Paclitaxel, Cisplatin
Type: Drug
Name: Cisplatin
Type: Drug
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Female
Criteria: 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
- 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
Location
Indira Gandhi Medical College
Shimla, Himachal Pradesh, India
Status: Recruiting
Contact: Pragyat Thakur, MBBS - 919418029244 - pragyat28rpgmc@gmail.com
Start Date
July 2011
Completion Date
February 2013
Sponsors
Indira Gandhi Medical College
Source
Indira Gandhi Medical College
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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