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OncoMatch/Clinical Trials/NCT06991465

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

Is NCT06991465 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including FOLFOX regimen and Capecitabine for colorectal carcinoma.

Phase 2RecruitingNeil KopekNCT06991465Data as of Jun 2026Location: Canada

Treatment: FOLFOX regimen · CapecitabineThe 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.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

Capecitabine

Other

FOLFOX regimen

Cancer type

Colorectal Cancer

Disease stage

Excluded: Stage T1 N0, T2 N0

mesorectum involved or breached - includes involvement of adjacent organ(s) (T3-T4); T1 or T2 N0 disease without extra-mural venous invasion [excluded]

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 90

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

Previous chemotherapy

Cannot have received: radiotherapy to the pelvis (including brachytherapy)

Previous radiotherapy to the pelvis (including brachytherapy)

Lab requirements

Blood counts

absolute neutrophil count >1.5x109/l; platelets >100x109/l

Kidney function

cockroft gault estimation >50 ml/min

Liver function

serum transaminase <3 x uln; bilirubin <1.5 x uln

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06991465 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 90 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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