Radiosensitizing Effect of Nelfinavir in Locally Advanced Carcinoma of Cervix

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

348

Participants

Timeline

Start Date

January 16, 2018

Primary Completion Date

August 17, 2024

Study Completion Date

September 30, 2025

Conditions
Carcinoma Cervix,Stage III
Interventions
DRUG

Nelfinavir

Nelfinavir (HIV protease inhibitor) targets proteasome and inhibits AKT phosphorylation and plays an important role in radiosensitization of tumour cells.Nelfinavir will be given to the patient orally with food, because the bioavailability increases under the influence of food.

DRUG

Cisplatin

Cisplatin will be administered on a weekly basis with a dose of 40 mg/m2 by IV infusion over a period of 1 hour 2-4 hours prior to start of EBRT. Patient will be premedicated with I.V Ondansetron to prevent emesis. Pre chemotherapy and post chemotherapy, patient will be administered IV fluids for effective renal clearance of cisplatin.

RADIATION

Pelvic EBRT and Brachytherapy

Pelvic EBRT will delivered by standard 4 field technique using 6MV/15 MV photon beams. Prior to delivery of radiation, patients will be simulated by CT simulator for planning the beam arrangements. Total dose of pelvic EBRT will be 45- 50Gy/23-25 #/5 weeks. The prescribed dose will be specified according to ICRU 50 guidelines. All patients will be treated with 3D conformal external radiation with target delineation and multileaf collimator leaf shaping.

Trial Locations (1)

400012

Tata Memorial Centre, Mumbai

All Listed Sponsors
lead

Tata Memorial Hospital

OTHER_GOV