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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Indira Gandhi Medical College.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr Pragyat Thakur, Indira Gandhi Medical College
ClinicalTrials.gov Identifier:
NCT01593306
First received: May 3, 2012
Last updated: May 7, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Carcinoma Cervix
Drug: Paclitaxel, Cisplatin
Drug: Cisplatin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Indira Gandhi Medical College:

Primary Outcome Measures:
  • clinical response of the disease [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • number of patients with adverse events [ Time Frame: during treatment, 14 weeks ] [ Designated as safety issue: Yes ]
    to monitor number of treatment related adverse events in both the arms


Estimated Enrollment: 80
Study Start Date: July 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593306

Contacts
Contact: Pragyat Thakur, MBBS 919418029244 pragyat28rpgmc@gmail.com

Locations
India
Indira Gandhi Medical College Recruiting
Shimla, Himachal Pradesh, India, 171001
Contact: Pragyat Thakur, MBBS    919418029244    pragyat28rpgmc@gmail.com   
Principal Investigator: Pragyat Thakur, MBBS         
Sponsors and Collaborators
Indira Gandhi Medical College
Investigators
Principal Investigator: Pragyat Thakur, MBBS Indira Gandhi Medical College
  More Information

No publications provided

Responsible Party: Dr Pragyat Thakur, Junior Resident, department of radiotherapy, Principal Investigator, Indira Gandhi Medical College
ClinicalTrials.gov Identifier: NCT01593306     History of Changes
Other Study ID Numbers: pragyat1805
Study First Received: May 3, 2012
Last Updated: May 7, 2012
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 29, 2014