Preserving the rectum in patients with rectal cancer using targeted radiation therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the potential for organ preservation in patients with locally advanced rectal adenocarcinoma who achieve a complete clinical response to short-course radiotherapy (SCRT). It aims to explore the safety and efficacy of a non-operative surveillance strategy, allowing patients to avoid surgery and its associated risks. The study will involve patients who are medically fit for oncologic resection and have specific disease characteristics as defined by pelvic MRI. By focusing on SCRT, the research seeks to validate findings from previous studies that suggest enduring clinical responses can be achieved without surgical intervention.

Why it matters

Who can join: the full rules

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

Where it's running

• McGill University Health Centre
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Neil Kopek, M.D. — Radiation Oncologist - Radiation Oncology
• Study coordinator: Neil Kopek, M.D.
• Email: neil.kopek@muhc.mcgill.ca
• Phone: 514-934-4400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.