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OncoMatch/Clinical Trials/NCT04808323

MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer

Is NCT04808323 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for rectal adenocarcinoma.

Phase 1RecruitingMedical College of WisconsinNCT04808323Data as of May 2026

Treatment: Capecitabine · Initial Dose of Radiation before Dose Escalation · Cohort A: Dose Escalation Radiation · Cohort B: Dose Escalation Radiation · Cohort C: Dose Escalation Radiation · FOLFOXThis study is a prospective, open-label, phase I design.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Required: Stage I, II, III

Excluded: Stage IV

Determined on staging evaluation to be clinical stage I, II or III.

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: radiation therapy

Lab requirements

Blood counts

ANC ≥ 1,000 cells/mm3; platelets ≥50,000 cells/mm3; hemoglobin ≥ 8.0 g/dl (transfusion/intervention allowed).

Kidney function

Not on hemodialysis. If age over 60, history of hypertension, diabetes or liver transplant, and GFR at enrollment is < 30 [excluded].

Liver function

ALT or AST < 4 x upper limit of normal; total bilirubin < 2 x upper normal mg/dL; alkaline phosphatase < 4 x upper limit of normal.

Laboratory values (CBC, Chem24) 45 days prior to treatment as follows: Carcinoembryonic antigen (CEA) (any value). Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3. Platelets ≥50,000 cells/mm3. Hemoglobin ≥ 8.0 g/dl. (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 4 x upper limit of normal. Total bilirubin < 2 x upper normal mg/dL. Alkaline phosphatase < 4 x upper limit of normal. Not on hemodialysis.

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

US trial sites

  • Froedtert & the Medical College of Wisconsin · Milwaukee, Wisconsin

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