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GOG-0238

Radiation Therapy With or Without Cisplatin in Treating Patients with Recurrent Endometrial Cancer

Status:

Recruiting | Phase II

Official Title:

A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients with Pelvic-only Recurrence of Carcinoma of the Uterine Corpus

Study Purpose:

To determine if adding chemotherapy to radiation therapy is better than radiation therapy alone to treat patients with endometrial cancer that has come back.  

Interventions:   

  • Radiation Therapy (high energy x-rays to kill cancer cells)
  • Chemotherapy: cisplatin
  • Lab Biomarker Analysis
  • Quality of Life questionnaires
  • ARM I: pelvic radiation therapy 5 days a week for 5 weeks. 
  • ARM II: cisplatin IV over 1-2 hours on day 1 and radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 5 weeks in the absence of disease progression or unacceptable side-effects.

After completion of study therapy, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter.

Key Participation Requirements:

Gender:

Female

Age:

19 years and older

Diagnosis:

Biopsy proven uterine cancer that has come back in the pelvis or vagina only.

Cell types:

endometrioid, mucinous, clear cell or serous adenocarcinomas; squamous cell, mixed or undifferentiated carcinomas

Eligibility:

Prior therapy: Radical Hysterectomy and Pelvic Lymphadenectomy

Hormone therapy and/or chemotherapy completed at least 6 months prior

Prior radiation is not allowed

Prior chemotherapy for the cancer that has returned is not allowed.      

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

GOG-0238

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!