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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 (Jun 2026). This Phase 1 trial studies multiple treatments for rectal adenocarcinoma.

Phase 1RecruitingMedical College of WisconsinNCT04808323Data as of Jun 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

Treatments studied

Chemotherapy

Capecitabine

Other

Initial Dose of Radiation before Dose EscalationCohort A: Dose Escalation RadiationCohort B: Dose Escalation RadiationCohort C: Dose Escalation RadiationFOLFOX

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

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT04808323 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior radiation therapy disqualifies patients from enrollment.

What disease stage is eligible?

Stage I or II or III is required.

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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