Phase I Study of Preoperative Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer
- Determine the maximum tolerated dose of neoadjuvant boost intensity-modulated
radiotherapy when combined with capecitabine before surgery in patients with locally
advanced rectal cancer.
- Determine the pathologic tumor response in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of boost intensity-modulated radiotherapy (IMRT).
Patients undergo neoadjuvant IMRT with incorporated boost once daily 5 days a week for 5
weeks. Beginning on the first day of radiotherapy, patients receive oral capecitabine twice
daily 7 days a week for 5 weeks. Patients undergo surgical resection 4-8 weeks after
completion of chemoradiotherapy.
Cohorts of 3-6 patients undergo escalating doses of boost IMRT until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3
of 6 patients experience dose-limiting toxicity.
Quality of life is assessed at baseline, at week 5 of chemoradiotherapy, before surgery, and
then at 1, 3, and 12 months after surgery.
Patients are followed at 1, 3, and 12 months after surgery.
PROJECTED ACCRUAL: Approximately 3-15 patients will be accrued for this study.
Primary Purpose: Treatment
Acute toxicity by CTCAE at 6 weeks following study completion
Gary Freedman, MD
Fox Chase Cancer Center
United States: Federal Government
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|