Non-Operative Management and Early Response Assessment in Rectal Cancer (NOM-ERA)
Adenocarcinoma of the Lower Rectum
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Lower Rectum
Eligibility Criteria
Inclusion Criteria:
- 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
- Tumor ≤ 12 cm from anal verge as determined by MRI or endoscopy
- Clinically detectable (MR, endoscopy, or DRE) tumor present
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- At least 18 years of age
Adequate bone marrow function defined as:
- Absolute neutrophil count (ANC) > 1,500 cells/mm3
- Hemoglobin> 8 g/dl
- Platelets >100,000 cells/mm3
- 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.
- Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document.
Exclusion Criteria
- Prior radiation therapy, chemotherapy or extirpative surgery for rectal cancer.
- Prior oxaliplatin or capecitabine use for any malignancy
- No prior radiation therapy to the pelvis.
- A history of other malignancy (except non-melanomatous skin cancers) with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
- Currently receiving any investigational agents.
- A history of allergic reaction attributed to compounds of similar chemical or biologic composition to capecitabine, 5FU, oxaliplatin, or leucovorin.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.
- Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective antiretroviral therapy (ART) according to Department of Health and Human Services (DHHS) treatment guidelines is recommended. HIV testing for patients without a history of HIV is not a protocol requirement.
Sites / Locations
- University of ColoradoRecruiting
- Mayo ClinicRecruiting
- Washington University School of MedicineRecruiting
- University of Vermont Medical CenterRecruiting
Arms of the Study
Arm 1
Experimental
Radiation + FOLFOX
Pelvic radiotherapy 5GY x 5 fractions once daily Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks). Oxaliplatin day 1 every 14 days Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available. 5-FU bolus day 1 every 14 days 5-FU infusion day 1 every 14 days over 46 hours Alternatively CAPOX (capecitabine and oxaliplatin) may be given for 5 cycles over 15 weeks. An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted