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

NCT01593306UNKNOWNPHASE3INTERVENTIONAL

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.

Key Facts

Lead Sponsor

Indira Gandhi Medical College, Shimla

Enrollment

80

Start Date

2011-07-01

Completion Date

2012-10-01

Study Type

INTERVENTIONAL

Interventions

PaclitaxelCisplatinCisplatin

Conditions

Carcinoma Cervix

Eligibility

Age Range

18 Years – 65 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

clinical response of the disease

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

Time frame: up to 1 year

Secondary Outcomes

number of patients with adverse events

to monitor number of treatment related adverse events in both the arms

Time frame: during treatment, 14 weeks

Locations

Indira Gandhi Medical College, Shimla, India

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