| Title |
Radical External Beam Chemoradiation in Patients With Rectal Cancer: a "Wait-and-see" Approach |
| Protocole ID |
14-407 GEN |
| ClinicalTrials.gov ID |
NCT03001362 |
| Cancer Type(s) |
Colon and Rectum |
| Phase |
Phase II |
| Stage |
|
| Study Type |
|
| Drug |
|
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| City |
Montréal |
| Principal Investigator |
Dr. Neil Kopek
|
| Coordinator |
Tatiana Carvalho
514-934-1934 poste 43698
|
| Status |
Recruiting |
| Activation Date |
|
| Eligibility 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
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Groupe d'étude en oncologie du Québec