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

Carcinoma Cervix Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01593306
• Other study ID #: pragyat1805
• Status: Recruiting
• Phase: Phase 3
• First received: May 3, 2012
• Last updated: May 7, 2012
• Start date: July 2011
• Est. completion date: February 2013

Study information

• Verified date: May 2012
• Source: Indira Gandhi Medical College
• Contact: Pragyat Thakur, MBBS
• Phone: 919418029244
• Email: pragyat28rpgmc[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma Cervix
• Uterine Cervical Neoplasms

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
India	Indira Gandhi Medical College	Shimla	Himachal Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Indira Gandhi Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical response of the disease	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	up to 1 year	No
Secondary	number of patients with adverse events	to monitor number of treatment related adverse events in both the arms	during treatment, 14 weeks	Yes