Organ Preservation in Rectal AdenoCa Using Hypofractionated Pelvic RT(Hypo-OPRA)

Recruiting now · Phase 2

Conditions studied: Colorectal Carcinoma

In brief

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.

Key facts

Study ID

NCT06991465

Run by

Neil Kopek

People needed

35

Starts

2023-08-16

Expected to finish

2029-06-30

Last updated by the study team

2025-05-28

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

• McGill University Health Centre — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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