Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer

Prior treatment

• Continuous systemic corticosteroid or immunosuppressant treatment.

Other illness

• Synchronous or metachronous (within 5 years) malignancies except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers.
• Infections requiring systemic treatment.
• Severe psychological disease.
• Uncontrollable diabetes mellitus.
• Uncontrollable hypertension.
• Unstable angina pectoris, or history of myocardial infarction within 6 months.
• Uncontrollable valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.

Lab values

• Positive serum Hepatitis B (HB)s antigen or serum Hepatitis C Virus (HCV) antibody.
• Positive serum HIV antibody.

Other

• Body temperature higher than 38 degrees Celsius at registration.
• Pregnant female, female within 28 days post-parturition, or lactating mother. Men with partners planning conception in the near future.
• Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT.

• Histopathologically proven adenocarcinoma or adenosquamous carcinoma on the resected specimen of the initial rectal cancer or endoscopic biopsy from the initial rectal cancer.
• The main tumor location of the initial rectal cancer is upper, middle or lower rectum, or anal canal.
• Either of the following treatments was performed for the initial rectal cancer, and classified as R0/1 or ER (Endoscopical R)0/1 on pathological diagnosis.
  • Surgical resection (including local resection, with or without lymph node dissection).
  • Endoscopic resection.
• Patients with distant metastasis during or after treatment for the initial rectal cancer, and radical surgical resection or radical radiotherapy performed more than 168 days before registration is eligible.
• Recurrent rectal cancer diagnosed by any of the following modalities after treatment for the initial rectal cancer.
  • The recurrent lesion is pathologically diagnosed. ii) Diagnosed as local recurrence by more than two modalities among contrast-enhanced CT, contrast-enhanced MRI, or positron emission computed tomography (PET).
  • Chronological progression of the lesion seen on more than one modality among contrast-enhanced CT, MRI, or PET.
• The main tumor location is within pelvis as seen on contrast-enhanced CT and MRI if recurrent lesion is multiple, or recurrent lesions spread outside of pelvis continuously.
• LRRC is diagnosed with no following condition. i) Judged as resectable endoscopically. ii) Depth of invasion within the muscularis propria as seen on contrast-enhanced CT, MRI, or PET in case of recurrence inside the intestine iii) Solitary ovarian metastasis. iv) Recurrence of the common iliac lymph node alone.
• LRRC is diagnosed as resectable, and all the following conditions must be fulfilled:
  • No distant metastasis on contrast-enhanced CT (cM0). ii) Estimated circumferential resection margin \>0 mm. iii) Leg amputation not required. iv) Preservation of the first sacral nerve possible.
• No prior surgery for recurrent rectal cancer.
• No prior pelvic irradiation for any malignancies.
• A patient who has received systemic chemotherapy for any malignancies and the final dose was administered more than 14 days ago.
• Age at registration is 20 to 80 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1.
• Measurable lesion is not mandatory.
• Adequate oral intake.
• Sufficient organ function. i) Neutrophil count \>= 1,500/mm3 ii) Hemoglobin \>= 9.0 g/dL iii) Platelet count \>= 100,000/mm3 iv) Total Bilirubin =\< 2.0 mg/dL v) Aspartate aminotransferase (AST) =\< 100 U/L vi) Alanine Aminotransferase (ALT) =\< 100 U/L vii) Cr =\< 1.5 mg/dL
• Open surgery or laparoscopic surgery is planned.
• Written informed consent is obtained.