Recruiting
Phase 2
Phase 3

Observational Study

Sponsor:

Sir Mortimer B. Davis - Jewish General Hospital

Code:

NCT03051464

Conditions

Stage II Rectal Cancer

Organ Preservation

Non-operative Treatment

Rectal Cancer (Stage III)

Rectal Cancer Patients

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Complete responders and Non-complete responders

Chemoradiation + EBRT Boost

Chemoradiation + HDRBT Boost

Study Details

Brief summary:

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).

Conditions

Stage II Rectal Cancer

Organ Preservation

Non-operative Treatment

Rectal Cancer (Stage III)

Rectal Cancer Patients

Study ID

NCT03051464

Start date

Apr 25, 2017

Status verified date

Dec, 2025

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 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 Design

Enrollment

131 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Chemoradiation + EBRT Boost

standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5; Complete responders and Non-complete responders

experimental: Chemoradiation + HDRBT Boost

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; Complete responders and Non-complete responders

Interventions

Complete responders and Non-complete responders

Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.

Chemoradiation + EBRT Boost

45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5

Chemoradiation + HDRBT Boost

45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions

Primary outcome measure

  • TME-free survival [ Time Frame: 2 years post treatment ]

Central Contacts and Locations

Central contacts

Susanne Knoepfel

5143408288sknoepfel@jgh.mcgill.ca

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Cristian Gonzales

214-645-5360Cristian.Gonzalez@UTSouthwestern.edu

Principal Investigator:

Aurelie Garant, MD

Le Centre Hospitalier de l'Université de Montreal

Recruiting

Montreal, Quebec, Canada, H2X0A9

Contacts

Nassima Taleb

514-890-8000nassima.taleb.chum@ssss.gouv.qc.ca

Principal Investigator:

Carole Richard, MD

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Susanne Knoepfel

514-340-8222sknoepfel@jgh.mcgill.ca

Principal Investigator:

Te Vuong, MD

Centre hospitalier universitaire de Québec

Recruiting

Québec, Quebec, Canada, G2L2Z3

More Information

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Last update posted

Jun 30, 2026

Last verified

Dec, 2025

Keywords

  • rectal cancer
  • non-operative management
  • rectal preservation
  • organ preservation
  • brachytherapy boost for rectal cancer
  • low rectal cancer curative treatment
  • mid rectal cancer curative treatment
  • rectal brachytherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sir Mortimer B. Davis - Jewish General Hospital on 2026-06-30.