A Pilot Phase II Two-Arm, Randomized Clinical Trial of Concomitant Immunotherapy (With Interferon-Alpha and Retinoic Acid) and Radiation Therapy for the Treatment of Advanced Cervical Cancer in India
A total of 200 women with confirmed diagnosis of invasive cervical cancer, stage III, will
be recruited into the study. The patients will be recruited from the Gynecologic Oncology
Department of the Chittaranjan National Cancer Institute that registers more than 600 cases
of cancer of the cervix per year. Computer-generated numbers will randomize patients into
the two treatment arms.
This trial is designed to treat stage III cervical cancer patients with concomitant
immunotherapy (with cis-retinoic acid and interferon-α) and radiotherapy in the study arm.
Cancer of the uterine cervix is the second most common cancer among women worldwide and is
the cause of the largest number of cancer-related deaths among women in the developing
countries. In India, cervical cancer is the commonest cancer among women (126,000 new
cases, 71,000 deaths in 2000), accounting for more than a quarter of the global burden of
cervical cancer (471,000 new cases and 233,000 deaths).1,2 In contrast, in the U.S.,
although, there were only 12,200 new cases of cervical cancer and 4,100 deaths in 2003, the
United States spends $5 billion per year screening and treating cervical cancer and
Advanced cervical cancer is relatively rare in the developed world because of routine PAP
testing. However, in a developing country like India, because of the absence of any
population based cervical cancer screening programs (HPV testing, PAP smears), nearly 80% of
the patients are initially detected at stage III or higher. Cisplatin-based chemotherapy
administered along with surgery and radiation is the recommended treatment for advanced
cervical cancer in the US and other developed countries.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival curves will be computed using the method of Kaplan and Meyer. The difference in survival between the two groups will be compared by log rank test with the O'Brien-Fleming boundaries to control for alpha spending at a planned interim analysis (50% of the total accrual).
3 years or death
Partha S Basu, MD
Chittaranjan National Cancer Institute
United States: Institutional Review Board