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Trial Title:
Concurrent Chemoradiotherapy With Weekly Cisplatin Versus Concurrent Chemoradiotherapy With Weekly Cisplatin and Paclitaxel in Locally Advanced Carcinoma Cervix
NCT ID:
NCT01593306
Condition:
Carcinoma Cervix
Conditions: Official terms:
Carcinoma
Paclitaxel
Cisplatin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Paclitaxel, Cisplatin
Description:
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.
Arm group label:
cisplatin and paclitaxel with concurrent radiotherapy
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
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.
Arm group label:
cisplatin with concurrent radiotherapy
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.
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.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Indira Gandhi Medical College
Address:
City:
Shimla
Zip:
171001
Country:
India
Status:
Recruiting
Contact:
Last name:
Pragyat Thakur, MBBS
Phone:
919418029244
Email:
pragyat28rpgmc@gmail.com
Investigator:
Last name:
Pragyat Thakur, MBBS
Email:
Principal Investigator
Start date:
July 2011
Completion date:
February 2013
Lead sponsor:
Agency:
Indira Gandhi Medical College, Shimla
Agency class:
Other
Source:
Indira Gandhi Medical College, Shimla
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01593306
