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No Surgery Trial / Two Dose-escalation Strategies

Stage II 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).

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 to 80

Participation Criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Study Location

Jewish General Hospital
Jewish General Hospital
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Stephan Bukera, BSc, MSc

[email protected]
514-340-8222
Hôpital Pierre Boucher
Hôpital Pierre Boucher
Longueuil, Quebec
Canada

Contact Study Team

Le Centre Hospitalier de l'Université de Montreal
Le Centre Hospitalier de l'Université de Montreal
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Nassima Taleb

[email protected]
514-890-8000
Centre hospitalier universitaire de Québec
Centre hospitalier universitaire de Québec
Québec City, Quebec
Canada

Contact Study Team

Primary Contact

André-Guy Martin, MD

Study Sponsored By
Sir Mortimer B. Davis - Jewish General Hospital
Participants Required
More Information
Study ID: NCT03051464