OncoMatch/Clinical Trials/NCT04749108
Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma
Is NCT04749108 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies Induction chemotherapy - modified FOLFIRINOX regimen for locally advanced malignant neoplasm.
Treatment: Induction chemotherapy - modified FOLFIRINOX regimen — Locally advanced rectal carcinoma raise the issue of both the oncological control, local and general, and the therapeutic morbidity. Surgery alone can cure only one out of two patients, radiochemotherapy improves the local control but the metastatic risk remains about 30% with enhanced postoperative morbidity and poor functional results. The tumor response to preoperative treatment is the major prognostic factor which revealed the aggressiveness of the tumor. To this day, there are no biologic predictive markers for tumor response. The purpose of this trial is to tailor the management according to the early tumoral response after short and intensive induction chemotherapy. MRI volumetric tumor response will be used to distinguish between good responders and bad responders. "Very good" responders will be randomized to either immediate surgery or radiochemotherapy followed by surgery (Standard arm: Cap 50).
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Colorectal Cancer
Disease stage
Required: Stage III
MRI evaluation of the locally advanced tumor before neoadjuvant chemotherapy
Performance status
WHO 0–1
Prior therapy
Must have received: FOLFIRINOX
Patient who receive Folfirinox
Cannot have received: pelvic radiotherapy
Patient with a history of pelvic radiotherapy
Lab requirements
Blood counts
Platelet count ≥ 100,000/mm3; Hemoglobin (Hb) ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥ 1,500/mm3
Kidney function
Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 50 ml/min (MDRD)
Liver function
Total bilirubin ≤ 1.5 x ULN, Alkaline phosphatases ≤ 3 x ULN and AST and ALT ≤ 3 x ULN
Adequate hematologic, hepatic, renal and ionogram function assessed within 7 days prior to study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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