Organ Preservation in Rectal AdenoCa Using Hypofractionated Pelvic RT(Hypo-OPRA)
Recruiting · NCT06991465 · Interventional (participants receive a specific treatment) · Lead sponsor: Neil Kopek
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The combination of preoperative pelvic RT - either long-course chemoradiotherapy (LCCRT) or short-course radiotherapy (SCRT)- followed by surgery has been the standard of care in the curative treatment of locally advanced adenocarcinoma of the rectum for decades. Some patients however achieve a complete clinical response (cCR) to their preoperative treatment which opens the possibility of avoiding surgery and consequently preserving the rectum. There now exists a growing body of data from centres around the world validating the safety of a surveillance approach in clinical complete responders treated with LCCRT.
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- McGill University Health Centre - Montreal, Quebec, Canada