Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Fox Chase Cancer Center
With
OBJECTIVES: Primary * Determine the maximum tolerated dose of neoadjuvant boost intensity-modulated radiotherapy when combined with capecitabine before surgery in patients with locally advanced rectal cancer. Secondary * 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
