A wait-and-see approach for rectal cancer patients after treatment
Radical External Beam Chemoradiation in Patients With Rectal Cancer: a "Wait-and-see" Approach
NA · McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT03001362
This study is testing whether some rectal cancer patients who respond well to treatment can safely skip surgery and just be closely monitored instead.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT03001362 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over with histologically proven adenocarcinoma of the rectum who are medically fit for oncologic resection.
Not a fit: Patients with previous pelvic radiotherapy or those with uncontrolled cardiorespiratory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for invasive surgeries and improve the quality of life for rectal cancer patients.
How similar studies have performed: Previous studies, particularly from Brazil, have shown promising results for the 'wait-and-see' approach in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Montreal, Quebec and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Carcinoma