Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer (JCOG1801)
Rectal Cancer Recurrent
About this trial
This is an interventional treatment trial for Rectal Cancer Recurrent focused on measuring Rectal cancer, Locally recurrent rectal cancer, Chemoradiotherapy, Surgery, Chemotherapy
Eligibility Criteria
Inclusion Criteria:
- 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.
i) Surgical resection (including local resection, with or without lymph node dissection).
ii) 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.
i) 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).
iii) 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:
i) 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.
Exclusion Criteria:
- 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.
- 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.
- Severe psychological disease.
- Continuous systemic corticosteroid or immunosuppressant treatment.
- Uncontrollable diabetes mellitus.
- Uncontrollable hypertension.
- Unstable angina pectoris, or history of myocardial infarction within 6 months.
- Uncontrollable valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
- Positive serum Hepatitis B (HB)s antigen or serum Hepatitis C Virus (HCV) antibody.
- Positive serum HIV antibody.
- Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT.
Sites / Locations
- Chiba Cancer CenterRecruiting
- Gifu University School of MedicineRecruiting
- Saitama Medical University International Medical Center
- Kansai Medical University Hospital
- Hiroshima City Asa Citizens HospitalRecruiting
- Hiroshima City HospitalRecruiting
- Shimane University Faculty of MedicineRecruiting
- Ishikawa Prefectural Central HospitalRecruiting
- National Cancer Center Hospital EastRecruiting
- Saitama Medical Center, Saitama Medical UniversityRecruiting
- Kochi Health Sciences CenterRecruiting
- Kumamoto University HospitalRecruiting
- Kurashiki Central HospitalRecruiting
- Kurume University School of MedicineRecruiting
- National Hospital Organization Shikoku Cancer CenterRecruiting
- Kyorin University Faculty of MedicineRecruiting
- Iwate Medical University
- Nagoya University Graduate School of Medicine
- Niigata Cancer Center HospitalRecruiting
- Hyogo College of MedicineRecruiting
- Okayama Saiseikai General HospitalRecruiting
- National Hospital Organization Osaka National HospitalRecruiting
- Osaka City General HospitalRecruiting
- Saitama Cancer CenterRecruiting
- Sapporo-Kosei General HospitalRecruiting
- Miyagi Cancer CenterRecruiting
- Shizuoka Cancer CenterRecruiting
- Osaka University Graduate School of MedicineRecruiting
- Suita Municipal HospitalRecruiting
- Osaka Medical CollegeRecruiting
- National Defense Medical CollegeRecruiting
- National Cancer Center HospitalRecruiting
- Toho University Ohashi Medical CenterRecruiting
- Toho University Omori Medical Center
- Tokyo Medical and Dental University HospitalRecruiting
- Tokyo Medical University HospitalRecruiting
- Tokyo Metropolitan Cancer and Infectious diseases Center Komagome HospitalRecruiting
- Tochigi Cancer CenterRecruiting
- Yamagata Prefectural Central HospitalRecruiting
- Kanagawa Cancer CenterRecruiting
- Saiseikai Yokohama-shi Nanbu HospitalRecruiting
- Yokohama City University Medical CenterRecruiting
- Oita University Faculty of MedicineRecruiting
- Ogaki Municipal HospitalRecruiting
- Gunma Prefectural Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm A
Arm B
Preoperative chemoradiotherapy (CRT) followed by Surgery plus Adjuvant chemotherapy Preoperative CRT: capecitabine (1650 mg/m2/day) and radiotherapy (50.4 Gy/28 Fr) Adjuvant chemotherapy: CAPOX (capecitabine+oxaliplatin) or mFOLFOX6 (5-fluorouracil+l-leucovorin+oxaliplatin) or capecitabine or 5-fluorouracil (FU) +l-leucovorin (LV) CAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14) mFOLFOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours. Capecitabine: 2000 mg/m2/day, twice daily, days 1-14 5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours
Surgery plus Adjuvant chemotherapy Adjuvant chemotherapy: CAPOX or mFOLFOX6 or capecitabine or 5-FU+l-LV CAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14) mFOLFOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours. Capecitabine: 2000 mg/m2/day, twice daily, days 1-14 5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours