Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery
Recruiting
Phase 2
Phase 3
Interventional Study
Stage II Rectal Cancer
Organ Preservation
Non-operative Treatment
Rectal Cancer (Stage III)
Rectal Cancer Patients
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 131 (estimated)
- Sponsor
- Sir Mortimer B. Davis - Jewish General Hospital · Other
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About This Trial
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 frac…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 d…
Contacts