Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery

Recruiting now · Phase 2/Phase 3

Conditions studied: Stage II Rectal Cancer, Organ Preservation, Non-operative Treatment, Rectal Cancer (Stage III), Rectal Cancer Patients

In brief

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).

Key facts

Study ID

NCT03051464

Run by

Sir Mortimer B. Davis - Jewish General Hospital

People needed

131

Starts

2017-04-25

Expected to finish

2030-01-01

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

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

Full record on ClinicalTrials.gov

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