Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery

What this study is about

A randomized study of 131 patients. Patients with a clinical T2-3 N0-1 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).

Who can join (things the study team will check)

✅ You may be able to join if…

• Rectal cancer patients, clinically staged as T2-T3a,b N0-1 by MRI or endoscopic/trans-rectal ultrasound
• Rectal cancer staged as N0-1 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

🚫 You may not be able to join if…

• Patients with previous pelvic radiation
• Evidence of distant metastasis
• Extension of malignant disease to the anal canal
• Tumors staged as T4
• Tumors larger than 5 cm in length

Where this trial is running

• UT Southwestern Medical Center, Dallas, Texas, United States
• Le Centre Hospitalier de l'Université de Montreal, Montreal, Quebec, Canada
• Jewish General Hospital, Montreal, Quebec, Canada
• Centre hospitalier universitaire de Québec, Québec, Quebec, Canada

Who to contact

Susanne Knoepfel · 5143408288 · sknoepfel@jgh.mcgill.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT03051464.