Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer

Korábbi kezelés

• Any prior pelvic radiation
• Other invasive malignancy undergoing active treatment. Patients receiving prior treatment that precludes standard chemoradiation or ability to receive consolidation/adjuvant chemotherapy will be excluded from survival analyses

Más betegség

• Diagnosis of inflammatory bowel disease (IBD)
• Diagnosis of MSI-H colorectal cancer at time of consent
• Recurrent rectal cancer

Egyéb

• Tumor is causing symptomatic bowel obstruction (patients who have diverting ostomy are eligible)
• Patients unwilling or unable to undergo pelvic MRI

• 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