Advanced Cervical Cancer Trial in India
Advanced Cervical Cancer Trial in India
The study objective:

 -  To evaluate the response and survival rates after treating stage III cervical cancer
 with retinoic acid and interferon-α combined with radiotherapy in the study group.

 -  To evaluate the response and survival rates after treating stage III cervical cancer
 patients with concomitant cisplatin and radiotherapy in the control group.

 -  To evaluate the safety and tolerability of the combination of retinoic acid,
 interferon-α and radiation therapy compared with concomitant chemo-radiation therapy.

 -  To determine if there is an immune response to Human Papillomavirus (HPV) by estimating
 serum IgG1 and IgG2 antibodies against E7 proteins of HPV types 16 and 18 before and
 after treatment.

 The study hypothesis:

 -  The response rates and survival rates of retinoic acid and interferon-α combination with
 radiation will be better than chemo-radiation to treat stage III cervical cancer.

 -  Treatment with the retinoic acid, interferon-α and radiation combination therapy will be
 less toxic and better tolerated than chemo-radiation therapy.
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 precancerous lesions.

 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.
Inclusion Criteria:

 -  Advanced cervical cancer

 Exclusion Criteria:

 -  Previously treated for cancer of the cervix

 -  Karnofsky Performance Score less than 50

 -  Renal dysfunction ( Serum creatinine > 2.0mg/dl)

 -  Hepatic dysfunction (Serum bilirubin> 2.0 mg/dl, transaminases > 1.5 times normal)

 -  Pregnant or lactating women: Women will be tested by pregnancy test for possibility of
 existing pregnancy. Those that meet criteria of trial will be asked to promise that
 they don't become pregnant; barrier contraception will be recommended.