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

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ClinicalTrials.gov Identifier: NCT01593306
Recruitment Status : Unknown
Verified May 2012 by Dr Pragyat Thakur, Indira Gandhi Medical College.
Recruitment status was:  Recruiting
First Posted : May 8, 2012
Last Update Posted : May 8, 2012
Sponsor:
Information provided by (Responsible Party):
Dr Pragyat Thakur, Indira Gandhi Medical College

Brief 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.

Condition or disease Intervention/treatment Phase
Carcinoma Cervix Drug: Paclitaxel, Cisplatin Drug: Cisplatin Phase 3

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : July 2011
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. clinical response of the disease [ Time Frame: up to 1 year ]
    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 :
  1. number of patients with adverse events [ Time Frame: during treatment, 14 weeks ]
    to monitor number of treatment related adverse events in both the arms



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action