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A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination With Intravenous Triapine in Women With Newly Diagnosed Bulky Stage IB2 Stage II IIIB or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

Research Study on Radiation Therapy and Investigational Treatments for Cervical and Vaginal Cancer

Recruiting
18 years and older
Female
Phase N/A

This study investigates the effectiveness of adding an investigational medication to standard treatment for cervical and vaginal cancer. The study focuses on patients with certain stages of cervical or vaginal cancer that cannot be treated with surgery alone. The purpose is to see if the investigational medication, combined with radiation and another drug, can improve the time patients live without the cancer getting worse, compared to the usual treatment of radiation and the other drug alone.

Participants will undergo different procedures depending on their assigned study arm. One arm will receive the investigational medication along with radiation therapy and a drug called cisplatin. The other arm will receive only radiation therapy and cisplatin. The investigational medication is being tested to see if it can increase the effectiveness of the standard treatment.

  • Who can participate: Women aged 18 and older with stage IB2, II, IIIB, or IVA cervical cancer, or stage II-IVA vaginal cancer, who cannot have surgery alone may participate. Participants must not have uncontrolled diabetes, known brain metastases, or certain allergies, and must not be breastfeeding.
  • Study details: Participants will be randomly assigned to receive either the investigational medication with radiation and cisplatin, or just radiation and cisplatin.
Study details
    cervical cancer
    uterine cervix cancer
    vaginal cancer
    uterine cancer
    cervix cancer
    cancer
    oncology

TX6613

19 February 2024

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