Trial Information

A Phase II Study of Local Excision Alone or Local Excision Plus Adjuvant Chemoradiation Therapy for Small Distal Rectal Cancers

OBJECTIVES:

- Determine the overall, disease-free, and colostomy-free survival rates in patients with
stage I rectal cancer treated with local excision with or without adjuvant chemotherapy
and radiotherapy.

- Determine the local, regional, and distant recurrence rates in patients treated with
these regimens.

- Determine whether loco-regional recurrences after local excision can be successfully
salvaged with radical surgery with or without adjuvant therapy for permanent cure in
patients treated with these regimens.

- Determine whether the analysis of certain histological and molecular markers can help
determine prognosis in patients treated with these regimens.

- Determine the anorectal, urinary, and sexual function effects in patients treated with
these regimens.

- Determine the non-functional treatment morbidity and mortality exclusive of anorectal,
urinary, and sexual function effects in patients treated with these regimens.

- Determine the overall survival of patients with pathology exclusions undergoing local
excision.

- Determine the efficacy of the current standard in detecting recurrence during
follow-up, including office visits, blood tests, and proctoscopy in patients treated
with these regimens.

OUTLINE: This is a multicenter study.

All patients undergo full thickness disc excision. Patients with T3 disease or positive
surgical margins after surgery are removed from study. Patients with T1 disease and negative
surgical margins after surgery are observed. Patients with T2 disease and negative surgical
margins after surgery receive adjuvant therapy.

Beginning 42 days after surgery, T2 patients receive leucovorin calcium (CF) IV over 2 hours
with fluorouracil (5-FU) IV bolus 1 hour into the infusion once weekly for 6 weeks.
Beginning 2 weeks after the completion of chemotherapy, patients receive chemoradiotherapy
comprising radiotherapy once daily 5 times a week for 5 weeks and 5-FU IV continuously while
receiving radiotherapy. Beginning 2 weeks after the completion of chemoradiotherapy,
patients again receive CF IV over 2 hours with 5-FU IV bolus 1 hour into the infusion once
weekly for 6 weeks. Chemotherapy repeats after 2 weeks rest for a total of 2 courses.

Patients are followed every 3 months for 2 years and then every 6 months for 5 years.

PROJECTED ACCRUAL: Approximately 320 patients will be accrued for this study within 5 years.