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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer

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Trial Information

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
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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival

Outcome Description:

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).

Outcome Time Frame:

3 years or death

Safety Issue:

Yes

Principal Investigator

Partha S Basu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chittaranjan National Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

464.05

NCT ID:

NCT01276730

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Advanced cervical cancer
  • India
  • Uterine Cervical Neoplasms

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