Recruiting

Observational Study

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT03001362

Conditions

Colorectal Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Radical external beam radiotherapy

Study Details

Brief summary:

Patients with histologically proven adenocarcinoma of the rectum will receive pelvic radiotherapy to a dose of 45Gy in 25 fractions with a tumor boost to a dose of 9Gy in 5 fractions (thus total of 54Gy/30Fx to the primary tumor), combined with radio sensitizing chemotherapy. Patients will then be closely monitored, through endoscopy and imaging, for response to treatment and relapse. Salvage oncologic surgery to be offered if there is failure to achieve complete clinical response or in the event of a loco regional relapse.

Conditions

Colorectal Carcinoma

Study ID

NCT03001362

Start date

Mar, 2015

Status verified date

May, 2025

Completion date

Jan, 2026

Anticipated

Primary completion date

Jul 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pelvic MRI defined disease (at least one of the following):

  • mesorectum involved or breached - includes involvement of adjacent organ (s) (T3-T4)
  • involvement of muscularis propria (T2)
  • extra-mural vascular invasion
  • tumour deposit within the mesorectum
  • one or more involved mesorectal lymph node
  • Patients are considered medically fit for oncologic resection
  • ECOG performance status 0 or 1
  • No evidence of established metastatic disease (CT chest and abdomen)
  • Absolute neutrophil count >1.5x109/L; platelets >100x109/L,
  • Serum transaminase <3 x ULN;
  • Adequate renal function (Cockroft Gault estimation >50 mL/min)
  • Bilirubin <1.5 x ULN
  • Ability to comply with oral medication
  • Willingness and ability to give informed consent and comply with treatment and follow up schedule
  • Age 18 or over

Exclusion Criteria:

  • Previous radiotherapy to the pelvis (including brachytherapy)
  • Enlarged extramesorectal nodes
  • Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months of randomisation)
  • T1N0 disease without extra-mural venous invasion
  • Unequivocal evidence of metastatic disease (includes resectable metastases)
  • Major impairment of bowel function without defunctioning stoma/ileostomy (baseline grade 3 diarrhoea or clinically significant faecal incontinence)
  • History of another malignancy within the last 5 years except successfully treated basal cell cancer of skin or carcinoma in situ of uterine cervix.
  • Known dihydropyrimidine dehydrogenase deficiency
  • Known Gilberts disease (hyperbilirubinaemia)
  • Taking warfarin or phenytoin or sorivudine
  • Gastrointestinal disorder which would interfere with oral therapy and its bioavailability
  • Pregnant, lactating, or pre-menopausal women not using adequate contraception
  • Unfit to receive any study treatment or subsequent surgical resection

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Radical External Beam RT for Colorectal Ca

A single arm consisting of: Radical external beam RT dose of 54 Gy in 30fx with radiosensitizing chemotherapy as per institutional standard

Interventions

Radical external beam radiotherapy

pelvic radiotherapy to a dose of 45 Gy in 25 fractions with a tumor boost to a dose of 9 Gy in 5 fractions (thus total of 54 Gy/30 fractions to the primary tumor), combined with radio sensitizing chemotherapy.

Primary outcome measure

  • Feasibility of a "wait and see" approach [ Time Frame: One year ]

Central Contacts and Locations

Central contacts

Neil Kopek, M.D.

514-934-4440neil.kopek@muhc.mcgill.ca

Marianna Perna, CCRP,CCRC

514-934-1934marianna.perna@muhc.mcgill.ca

Locations

McGill University Health Centre- Cedars Cancer Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Neil Kopek, M.D.

514-934-4440neil.kopek@muhc.mcgill.ca

Marianna Perna, CCRP, CCRC

514-934-1934marianna.perna@muhc.mcgill.ca

Principal Investigator:

Neil Kopek, M.D.

McGill University Health Center-Cedars Cancer Centre

Recruiting

Montréal, Quebec, Canada, H4A 3J1

Contacts

Marianna Perna, CCRP,CCRC

514-934-1934marianna.perna@muhc.mcgill.ca

Tatiana Carvalho, CCRP

514-934-1934tatiana.carvalho@muhc.mcgill.ca

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

May 15, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2025-05-15.