Concurrent Chemoradiotherapy With Weekly Cisplatin Versus Concurrent Chemoradiotherapy With Weekly Cisplatin and Paclitaxel in Locally Advanced Carcinoma Cervix
This study is currently recruiting participants.
Verified May 2012 by Indira Gandhi Medical College
Sponsor:
Indira Gandhi Medical College
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
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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
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:
|
Uterine Cervical Diseases Carcinoma Uterine Cervical Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site 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 June 13, 2013