A wait-and-see approach for rectal cancer patients after treatment

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 clinical trial investigates the effectiveness of a 'wait-and-see' approach for patients with rectal cancer who achieve a complete clinical response after receiving pelvic radiotherapy combined with chemotherapy. Patients will undergo close monitoring through endoscopy and imaging to assess their response to treatment and detect any relapses. If a complete clinical response is not achieved or if there is a local relapse, salvage oncologic surgery will be offered. The goal is to determine whether radical surgery is necessary for patients whose tumors have been effectively treated with chemoradiotherapy.

Why it matters

Who can join: the full rules

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

Where it's running

• McGill University Health Center-Cedars Cancer Centre
  Montreal, Quebec, Canada Recruiting
• McGill University Health Centre- Cedars Cancer Centre
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Neil Kopek, M.D. — Radiation Oncologist
• Study coordinator: Neil Kopek, M.D.
• Email: neil.kopek@muhc.mcgill.ca
• Phone: 514-934-4440

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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.