Phase III Randomized Study of Preoperative Capecitabine and Radiation Therapy Versus Fluorouracil and Radiation Therapy in Patients With Resectable Rectal Cancer
RATIONALE: Drugs used in chemotherapy, such as capecitabine, fluorouracil, and oxaliplatin
work in different ways to stop tumour cells from dividing so they stop growing or die.
Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: This randomized phase III trial is studying radiation therapy and either
capecitabine or fluorouracil with or without oxaliplatin and comparing them to see how well
they work when given before surgery in treating patients with resectable rectal cancer. It
is not yet known whether radiation therapy and either capecitabine or fluorouracil is more
effective with or without oxaliplatin in treating rectal cancer.
OUTLINE: This is a randomized,
multicentre study. Patients are stratified according to participating centre,
gender, clinical tumour stage (stage II vs stage III), and surgical intent
(sphincter saving vs non-sphincter saving). Patients are randomized to 1 of 4
Within 6-8 weeks after the
completion of chemoradiotherapy, patients with responding or stable disease
undergo surgery. Patients with progressive disease are treated at the discretion
of the investigator and continue to be followed.
Quality of life is assessed at
baseline, at completion of chemoradiotherapy, and at 1 year after surgery.
After completion of study
treatment, patients are followed every 6 months for 5 years.
View this trial on ClinicalTrials.gov
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