Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer
Locally Advanced Rectal Carcinoma, Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8
About this trial
This is an interventional treatment trial for Locally Advanced Rectal Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed rectal adenocarcinoma
- Patients must have stage II (cT3, cN0) or stage III (cT1-3, cN1-3) tumor as staged by MRI
- No evidence of metastatic disease
- Resectable primary lesion
- Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2
- Absolute neutrophil count (ANC) > 1.5 cell/mm^3
- Hemoglobin (Hgb) > 8.0 gm/dL
- Platelets (PLT) > 150,000/mm^3
- Total bilirubin < or equal to 1.5 x upper limit of normal
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < or equal to three times upper limit of normal
- If a woman is of childbearing potential, a negative serum pregnancy test must be documented prior to initiation of radiation therapy
Exclusion Criteria:
- Active treatment of a separate malignancy
- Distant metastatic disease as assessed by staging positron emission tomography (PET)/computed tomography (CT) or CT of the chest and abdomen within 6 weeks of starting radiation therapy
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Pregnant and/or breastfeeding
- Medical/psychological contraindication to MRI
Sites / Locations
- UCLA / Jonsson Comprehensive Cancer CenterRecruiting
Arms of the Study
Arm 1
Experimental
Treatment (IMRT, mFOLFOX6, CapeOX, TME)
Patients undergo SCRT in the form of IMRT over 5 fractions daily for 5 consecutive days. Beginning 11-18 days after the last day of radiation therapy, patients receive either oxaliplatin IV and leucovorin IV on day 1 and fluorouracil IV on days 1-3 (mFOLFOX6) or oxaliplatin IV on day 1 and capecitabine PO BID on days 1-14 (CapeOX). Treatment with mFOLFOX6 repeats every 2 weeks for up to 8 cycles, and treatment with CapeOX repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. At 8-12 weeks after completion of all therapy, patients with residual tumor undergo TME. Patients with cCR undergo NOM.