OncoMatch/Clinical Trials/NCT06991465
Organ Preservation in Rectal AdenoCa Using Hypofractionated Pelvic RT(Hypo-OPRA)
Is NCT06991465 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including FOLFOX regimen and Capecitabine for colorectal carcinoma.
Treatment: FOLFOX regimen · Capecitabine — 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.
Check if I qualifyExtracted eligibility criteria
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)
Prior therapy
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.
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