Recruiting
Phase 2

Hypofractionated RT

Sponsor:

Neil Kopek

Code:

NCT06991465

Conditions

Colorectal Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Radiation Therapy

FOLFOX regimen

Capecitabine

Study Details

Brief summary:

The combination of preoperative pelvic RT - either long-course chemoradiotherapy (LCCRT) or short-course radiotherapy (SCRT)- followed by surgery has been the standard of care in the curative treatment of locally advanced adenocarcinoma of the rectum for decades. Some patients however achieve a complete clinical response (cCR) to their preoperative treatment which opens the possibility of avoiding surgery and consequently preserving the rectum. There now exists a growing body of data from centres around the world validating the safety of a surveillance approach in clinical complete responders treated with LCCRT.

Conditions

Colorectal Carcinoma

Study ID

NCT06991465

Start date

Aug 16, 2023

Status verified date

May, 2025

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed invasive adenocarcinoma of the rectum
  • Pelvic MRI defined disease (at least one of the following):

mesorectum involved or breached - includes involvement of adjacent organ(s) (T3-T4)

  • 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 chemotherapy
  • Previous radiotherapy to the pelvis (including brachytherapy)
  • Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months of randomisation)
  • T1 or T2 N0 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
  • Known dihydropyrimidine dehydrogenase deficiency
  • 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 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

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hypofractionated Pelvic Radiotherapy

A single arm consisting of hypofractionated RT dose of 25 Gy in 5 fractions once daily fractions of intensity modulated radiotherapy (IMRT) with a simultaneous integrated boost up to 35 Gy on sites of gross disease (tumour and lymphadenopathy).

Interventions

Radiation Therapy

High Dose Hypofractionated Radiotherapy 35 Gy over 5 fractions.

FOLFOX regimen

Radiosensitizing chemotherapy

Capecitabine

Radiosensitizing chemotherapy

Primary outcome measure

  • Feasibility of Hypo-fractionated Approach in 5 fractions for a dose of 35Gy [ Time Frame: One year ]

Central Contacts and Locations

Central contacts

Neil Kopek, M.D.

514-934-4400neil.kopek@muhc.mcgill.ca

Tarel Hijal, M.D.

514-934-4400tarek.hijal@muhc.mcgill.ca

Locations

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Neil Kopek, M.D.

514-934-4400neil.kopek@muhc.mcgill.ca

Tarek Hijal, M.D.

514-934-4400tarek.hijal@muhc.mcgill.ca

More Information

Sponsor

Neil Kopek

Last update posted

May 28, 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 Neil Kopek on 2025-05-28.