Patients With Rectal Cancer: a "Wait-and-see" Approach

Recruiting now · Not applicable

Conditions studied: Colorectal Carcinoma

In brief

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.

Key facts

Study ID

NCT03001362

Run by

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

People needed

48

Starts

2015-03-01

Expected to finish

2026-01-01

Last updated by the study team

2025-05-15

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• McGill University Health Center-Cedars Cancer Centre — Montreal, Quebec, Canada (enrolling)
• McGill University Health Centre- Cedars Cancer Centre — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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