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

May 3, 2012
May 7, 2012
July 2011
October 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01593306 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Concurrent Chemoradiotherapy With Weekly Cisplatin Versus Concurrent Chemoradiotherapy With Weekly Cisplatin and Paclitaxel in Locally Advanced Carcinoma Cervix
Not Provided

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Carcinoma Cervix
  • 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.
  • 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.
  • 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
    Intervention: Drug: Paclitaxel, Cisplatin
  • 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
    Intervention: Drug: Cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
February 2013
October 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact: Pragyat Thakur, MBBS 919418029244 pragyat28rpgmc@gmail.com
India
 
NCT01593306
pragyat1805
Yes
Dr Pragyat Thakur, Indira Gandhi Medical College
Indira Gandhi Medical College
Not Provided
Principal Investigator: Pragyat Thakur, MBBS Indira Gandhi Medical College
Indira Gandhi Medical College
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP