Trial Information

Treatment of Patients With Stage IB2 Carcinoma of the Cervix: A Randomized Comparison of Radical Hysterectomy and Tailored Chemo-Radiation Versus Primary Chemo-Radiation

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.