Carcinoma Cervix
Conditions
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.
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.
Interventions
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.
DRUGCisplatin
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.
Sponsors
Indira Gandhi Medical College, Shimla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| number of patients with adverse events | during treatment, 14 weeks | to monitor number of treatment related adverse events in both the arms |
Countries
India
Contacts
Primary ContactPragyat Thakur, MBBS
Outcome results
None listed