Advanced Cervical Cancer Trial in India

PHASE2CompletedINTERVENTIONAL
Enrollment

209

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Cervical Cancer
Interventions
DRUG

Interferon, Retinoic Acid and radiation

Interferon-α2b will be administered 3 times a week for four weeks at a dose of 3 x 106 IU subcutaneously concomitant with radiotherapy. The first dose will be administered on the day the subject starts radiotherapy; 13-cis-retinoic acid will be administered orally at a dose of 40 mg/day for 1 month starting from day 1 of radiotherapy; a total of 40 to 45 Gy whole pelvis irradiation will be delivered in conventional fractions to both the study group and the control group. Additional parametrial dosages will be delivered to complete 55 Gy. This will be followed by two intracavitary applications of approximately 40-50 Gy, depending on the volume.

DRUG

Cisplatin and radiation

Weekly cisplatin will be administered concurrent with external beam radiation at a dose of 40mg/m2/week for 5 weeks; a total of 40 to 45 Gy whole pelvis irradiation will be delivered in conventional fractions. Additional parametrial dosages will be delivered to complete 55 Gy. This will be followed by two intracavitary applications of approximately 40-50 Gy, depending on the volume.

Trial Locations (1)

700026

Chittaranjan National Cancer Institute, Kolkata

All Listed Sponsors
collaborator

James Graham Brown Cancer Center

OTHER

lead

University of Louisville

OTHER

NCT01276730 - Advanced Cervical Cancer Trial in India | Biotech Hunter | Biotech Hunter