Concurrent Chemoradiotherapy With Weekly Cisplatin Versus Concurrent Chemoradiotherapy With Weekly Cisplatin and Paclitaxel in Locally Advanced Carcinoma Cervix
Study Details
Study Description
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 |
|---|---|---|
|
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- clinical response of the disease [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
- number of patients with adverse events [during treatment, 14 weeks]
to monitor number of treatment related adverse events in both the arms
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indira Gandhi Medical College | Shimla | Himachal Pradesh | India | 171001 |
Sponsors and Collaborators
- Indira Gandhi Medical College, Shimla
Investigators
- Principal Investigator: Pragyat Thakur, MBBS, Indira Gandhi Medical College, Shimla
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- pragyat1805