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GOG-0263

Radiation Therapy With or Without Chemotherapy In Patients with Stage I or Stage II Cervical Cancer Who Previously Underwent Surgery

Status:

Recruiting | Phase III

Official Title:

Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy

Study Purpose:

To determine if adding chemotherapy to radiation therapy (CRT) can prevent or lengthen the time to recurrence when compared to radiation therapy (RT) alone.

Interventions:

  • Radiation Therapy (high energy x-rays to kill cancer cells)
  • Chemotherapy: cisplatin 
  • Lab Biomarker Analysis
  • Quality of Life questionnaires
  • ARM I: Pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks. Should these have links or explanations?
  • 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 6 courses in the absence of disease progression or unacceptable toxicity.

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:

Stage Ia, Ib, and IIa cervical cancer 

Marker Status:

Squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma

Eligibility:

Radical Hysterectomy and Pelvic Lymphadenectomy only

Must be registered to the study within 8 weeks following surgery.

Patients are not eligible if they have had a cancer diagnosis in the previous 5 years, with the exception of non-melanoma skin cancer.

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

Methodist Health System Trial Code: 

GOG-0263

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

To learn more, or to participate in this trial, contact us today!