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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Carcinoma Cervix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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cisplatin and paclitaxel with concurrent radiotherapy

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

Group Type EXPERIMENTAL

Paclitaxel, Cisplatin

Intervention Type DRUG

intravenous paclitaxel infusion at 50mg/m2/week and cisplatin at 30mg/m2/week for 5 weeks. if supplement Chemo Radiotherapy is required then similar dose per week for 2 more weeks.

cisplatin with concurrent radiotherapy

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

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

intravenous infusion of cisplatin 40mg/m2/week for 5 weeks. if I/C Brachytherapy is not feasible then supplement CRT given with similar dose of cisplatin for 2 more cycles.

Interventions

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Paclitaxel, Cisplatin

intravenous paclitaxel infusion at 50mg/m2/week and cisplatin at 30mg/m2/week for 5 weeks. if supplement Chemo Radiotherapy is required then similar dose per week for 2 more weeks.

Intervention Type DRUG

Cisplatin

intravenous infusion of cisplatin 40mg/m2/week for 5 weeks. if I/C Brachytherapy is not feasible then supplement CRT given with similar dose of cisplatin for 2 more cycles.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No