Neoadjuvant Chemotherapy Followed by Surgery Versus Concurrent Chemoradiation in Carcinoma of the Cervix

• Status: Unknown status
• Trial end date: 2020-07-31
• Target enrollment: 0
• Participant gender: Female

Summary

Carcinoma cervix is a common malignancy in women in developing countries including India. The standard treatment of locally advanced cervical cancer (Stages IB2 to IIIB)is concomitant chemoradiation (CT RT) using platinum based chemotherapy. Some studies, including a meta-analysis conducted by the Cochrane group, have indicated that few courses of neoadjuvant chemotherapy (NACT) followed by surgery may be superior to radical radiation alone for these patients. However NACT-Surgery approach has never been compared to the current standard of concomitant CT RT. The present study is undertaken to compare, in a randomized trial, NACT(3 courses of paclitaxel-carboplatin) followed by surgery to concomitant CT RT in stages IB2 to IIB squamous cell carcinoma of the uterine cervix.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sudeep Gupta; Tata Memorial Hospital
• Treatments: Carboplatin; Cisplatin; Paclitaxel

Criteria

Inclusion Criteria:

1. Women with histologically proven invasive squamous cell carcinoma of the uterine cervix, stages IB2-IIB.

2. Age 18-65 years (both inclusive)

3. No evidence of visceral, skeletal or extra-abdominal nodal metastases.

4. No history of prior or present second malignancy

5. Good performance status (Karnofsky performance score > 70 or ECOG PS <2)

6. Normal hematological & biochemical parameters including normal renal function.

7. Presence of associated co-morbid conditions that preclude participation in the study.

8. No prior treatment.

9. Informed consent for participation in the study.