Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix

OBJECTIVES:

• Compare progression-free survival and survival of patients with stage IB2 carcinoma of the cervix after radical hysterectomy with tailored chemoradiotherapy vs primary chemoradiotherapy.

• Compare the toxicity of these regimens in these patients.

• Compare the health-related quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: (Surgery followed by chemoradiotherapy): Patients undergo exploratory laparotomy followed by radical hysterectomy and bilateral pelvic and para-aortic lymphadenectomy. Depending on the findings at surgery, the radical hysterectomy and lymphadenectomy are either completed or aborted.

  • Aborted hysterectomy: Patients with aborted hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery.

    • Group 1: Within 4 weeks of surgery, patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavitary irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 5-6 doses.

    • Group 2: Patients receive radiotherapy and cisplatin as in group 1 with additional extended field radiotherapy.

    • Group 3: Patients receive further treatment at the discretion of the investigator.

  • Completed hysterectomy: Patients completing the radical hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery.

    • Group A: Patients receive treatment as in group 1 above without intracavity irradiation.

    • Group B: Patients receive treatment as in group 2 above without intracavity irradiation.

    • Group C: Patients receive no further treatment.

• Arm II (Primary chemoradiotherapy): Patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavity irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 6 doses.

Quality of life is assessed at baseline, during week 5 of therapy, and then at 3, 6, and 12 months.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 740 patients (370 per treatment arm) will be accrued for this study within 7.5 years.