Organ Preservation With Active Surveillance After Chemoradiation in Rectal Cancer (OPTION)
This pilot trial studies how well active surveillance and chemotherapy before surgery work in treating participants with stage II-III rectal cancer. Active surveillance involves monitoring participants for additional tumor growth after receiving cancer treatment. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether deferring surgery after active surveillance and chemotherapy will work better in treating participants with stage II-III rectal cancer.
• Histologically confirmed diagnosis of rectal adenocarcinoma
• Eligible for curative resection of rectal adenocarcinoma
• Rectal tumor location =\< 12 cm from the anal verge as determined by endoscopy or magnetic resonance imaging (MRI) (if endoscopy report is not available or deemed inadequate my treating oncologist)
• Nodal involvement confined to the radiation field
• Radiologically measurable or clinically evaluable disease as defined in the protocol
• Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0, 1 or 2
• Clinical Stage: Stage II and III. N2 disease is to be estimated as four or more lymph nodes that are \>= 10 mm. Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon including digital rectal exam (DRE), computed tomography (CT) or positron emission tomography (PET)/CT scan of the chest/abdomen/pelvis and a pelvic MRI. If a pelvic MRI is performed, it is acceptable to perform CT of the chest/abdomen, omitting CT imaging of the pelvis. PET/CT is optional.
• No known contraindication to standard (fluoropyrimidine-based) pelvic chemoradiation (e.g. dihydropyrimidine dehydrogenase \[DPD\] deficiency)
• Patient of child-bearing potential is willing to employ adequate contraception during treatment and after treatment, as directed by treating clinical team
• Willing to provide written informed consent
• Willing to return to enrolling medical site for all study assessments