A Phase III Study Testing Two Dose Escalation Strategies to Increase the Population of Complete Responders After Radiation Therapy in the Context of Organ Preservation for Patients With Rectal Cancer
A randomized study of 131 patients. Patients with a clinical T2-3 N0 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).
• Rectal cancer patients, clinically staged as T2-T3 by MRI or endoscopic/trans-rectal ultrasound
• Rectal cancer staged as N0 by MRI or EUS/TRUS
• No metastatic lesion
• Rectal tumor occupying less than half of the circumference
• Tumor less than 5 cm on its largest dimension
• Tumor located at less than 10 cm from the anal verge
• Tumor penetration less than 5 mm in the mesorectal fat
• Tumor accessible for brachytherapy
• Lumen accessible for colonoscopy
• Patient should be a suitable candidate for brachytherapy and chemotherapy
• Older than 18 years of age
• Adequate birth control measures in women of childbearing potential
• Written informed consent