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

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.

Study Overview

• Status: Unknown
• Conditions: Carcinoma Cervix
• Intervention / Treatment: Drug: Paclitaxel, Cisplatin; Drug: Cisplatin

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pragyat Thakur, MBBS; Phone Number: 919418029244; Email: pragyat28rpgmc@gmail.com

Study Locations

• India
  • Himachal Pradesh
    • Shimla, Himachal Pradesh, India, 171001
      • Recruiting
      • Indira Gandhi Medical College
      • Contact: Pragyat Thakur, MBBS; Phone Number: 919418029244; Email: pragyat28rpgmc@gmail.com
      • Principal Investigator: Pragyat Thakur, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
Active Comparator: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients with adverse events	to monitor number of treatment related adverse events in both the arms	during treatment, 14 weeks

Collaborators and Investigators

• Sponsor: Indira Gandhi Medical College, Shimla
• Investigators: Principal Investigator: Pragyat Thakur, MBBS, Indira Gandhi Medical College, Shimla

Publications and helpful links

General Publications

• Thakur P, Seam R, Gupta M, Gupta M. Prospective randomized study comparing concomitant chemoradiotherapy using weekly cisplatin & paclitaxel versus weekly cisplatin in locally advanced carcinoma cervix. Ann Transl Med. 2016 Feb;4(3):48. doi: 10.3978/j.issn.2305-5839.2015.11.19.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): October 1, 2012
• Study Completion (Anticipated): February 1, 2013

Study Registration Dates

• First Submitted: May 3, 2012
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (Estimate): May 8, 2012

Study Record Updates

• Last Update Posted (Estimate): May 8, 2012
• Last Update Submitted That Met QC Criteria: May 7, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Cisplatin
• Other Study ID Numbers: pragyat1805