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

Launched by NEIL KOPEK · May 23, 2025

Keywords

ClinConnect Summary

The Hypo-OPRA trial is studying how to best treat patients with locally advanced rectal cancer, specifically looking at whether a combination of radiation therapy before surgery can help preserve the rectum in some patients. Traditionally, patients receive radiation therapy followed by surgery, but this trial is exploring the option for those who show a complete response to the treatment to avoid surgery altogether. This approach aims to maintain the quality of life for patients while effectively managing their cancer.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of invasive adenocarcinoma of the rectum. They should be in good overall health and not have any evidence of cancer spreading to other parts of the body. Participants can expect to undergo preoperative radiation therapy, and if they show a complete response, they may be able to avoid surgery. It’s important for potential participants to discuss their medical history and current health with their doctors to see if they qualify for this study.

Gender

ALL

Eligibility criteria

• 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