NCT03051464

Brief Summary

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P75+ for phase_2

Timeline
44mo left

Started Apr 2017

Longer than P75 for phase_2

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Apr 2017Jan 2030

First Submitted

Initial submission to the registry

February 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

April 25, 2017

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

February 17, 2026

Status Verified

December 1, 2025

Enrollment Period

10.7 years

First QC Date

February 7, 2017

Last Update Submit

February 12, 2026

Conditions

Stage II Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • TME-free survival

    Time from date of randomization to either TME or death in the intention to treat population

    2 years post treatment

Secondary Outcomes (4)

  • Local Recurrence

    2 years post treatment

  • Disease-free survival

    5 years post treatment

  • Overall survival

    5 years post treatment

  • Overall Quality of life

    5 years post treatment

Study Arms (2)

Chemoradiation + EBRT Boost

EXPERIMENTAL

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

Procedure: Complete responders and Non-complete respondersRadiation: Chemoradiation + EBRT Boost

Chemoradiation + HDRBT Boost

EXPERIMENTAL

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

Procedure: Complete responders and Non-complete respondersRadiation: Chemoradiation + HDRBT Boost

Interventions

Complete responders and Non-complete respondersPROCEDURE

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

Chemoradiation + EBRT BoostChemoradiation + HDRBT Boost
Chemoradiation + EBRT BoostRADIATION

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

Chemoradiation + EBRT Boost
Chemoradiation + HDRBT BoostRADIATION

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

Chemoradiation + HDRBT Boost

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Le Centre Hospitalier de l'Université de Montreal

Montreal, Quebec, H2X0A9, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Centre hospitalier universitaire de Québec

Québec, Quebec, G2L2Z3, Canada

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapy

Study Officials

  • Te Vuong, MD

    Sir Mortimer Jewish General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne Knoepfel

CONTACT

5143408288sknoepfel@jgh.mcgill.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Radiation Oncology Department

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 13, 2017

Study Start

April 25, 2017

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2030

Last Updated

February 17, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)US(1)