Non-Operative Management and Early Response Assessment in Rectal Cancer (NOM-ERA)
1. Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-2a, M0) adenocarcinoma of the rectum; staging must also be based on multidisciplinary evaluation including MRI 2. Tumor ≤ 12 cm from anal verge as determined by MRI or endoscopy 3. Clinically detectable (MR, endoscopy, or DRE) tumor present 4. ECOG performance status 0-2 5. At least 18 years of age 6. Adequate bone marrow function defined as: a. ANC > 1,500 cells/mm3 b. Hgb > 8 g/dl c. platelets >100,000 cells/mm3 7. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. 8. Able to understand and willing to sign an IRB-approved written informed consent document.
Memorial Hospital Central
Memorial Hospital North
Jeffrey Olsen, MD
Protocol Number: 20-2227
More information available at ClinicalTrials.gov: NCT03904043
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