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Phase 3
18 Years
65 Years
Open (Enrolling)
Carcinoma Cervix

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Trial Information

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.

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

- deranged renal function test and liver function test

- KPS >= 60

- distant metastasis

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

clinical response of the disease

Outcome Description:

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

Outcome Time Frame:

up to 1 year

Safety Issue:


Principal Investigator

Pragyat Thakur, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indira Gandhi Medical College


India: Institutional Review Board

Study ID:




Start Date:

July 2011

Completion Date:

February 2013

Related Keywords:

  • Carcinoma Cervix
  • Carcinoma
  • Uterine Cervical Neoplasms