Resectable locally advanced rectal cancer
Conditions
Interventions
Preoperative administration of six courses mFOLFOX6 + bevacizumab (5mg) followed by 50.4Gy chemoradiation (1.8Gy x28) with S-1 (80-120mg daily on days 1-14 and 22-35)
Sponsors
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Rectal adenocarcinoma diagnosed pathologically at the Department of Pathology, Cancer Institute Hospital, Tokyo, Japan. 2) Patients with MRI and CT-defined locally advanced rectal cancer who meet either of the following clinical criteria. * Lateral lymph node metastasis and/or 4 or more mesorectal lymph node metastases (N2-3 as defined by the 7th edition of the Japanese Classification of Colorectal Carcinoma). * Lymph node metastasis along the proximal superior mesenteric artery (N2-3 as defined by the 6th edition of the Japanese Classification of Colorectal Carcinoma). * Tumors extending to within 1 mm of or beyond the mesorectal fascia (ie, CRM involved or threatened). * T3 low-lying tumors at or below the levators or T4 tumors invading to the levators (ie, abdominoperineal resection needed for R0 resection). * T4 tumors invading to surrounding structures or peritoneum. * Tumors extending 5 mm or more into perirectal fat. 3) Lower edge of tumors located at or below the lower edge of the second sacrum (Ra/Rb rectal cancer as defined by the 7th edition of the Japanese Classification of Colorectal Carcinoma). 4) R0 resection is possible before treatment. 5) No distant metastasis. 6) Performance Status (ECOG) 0 or 1. 7) No preceding preoperative radiotherapy, chemotherapy or hormonal therapies. 8) Function of major organs is well-preserved, including bone marrow, heart, lung and kidney. 9) Oral administration is possible. 10) Written informed consent is obtained.
Exclusion criteria
Exclusion criteria: 1) Contraindication for either of S-1, Oxaliplatin, 5-FU, Leucovorin or Bevasizumab 2) Past history of severe hypersensitivity to the drugs 3) Past history of irradiation to the pelvis 4) Presence of infection with fever 5) Presence of severe morbidity such as heart failure, interstitial pneumonia, pulmonary fibrosis, uncontrollable diabetes, renal failure and liver failure. 6) Presence of sensory neuropathy 7) Presence or clinical manifestation of brain metastasis 8) Presence of diarrhea daily 9) Presence of ascites and/or pleural effusion which need aspiration 10) Presence of concomitant malignancy or past history of malignancy within five years 11) Female with pregnancy 12) Male who desire to keep fertility 13) Other inappropriate cases judged by doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety (proportion of adverse events and morbidity), R0 resection rate, Response rate, Proportion of clinical downstaging, Three-year recurrence free survival, Proportion of gastrointestinal perforation during the treatment | — |
Countries
Japan
Contacts
Public ContactTsuyoshi Konishi
The Cancer Institute Hospital of Japanese Foundation for Cancer Research Gastroenterological Surgery
Outcome results
None listed