small bowel adenocarcinoma
Conditions
Interventions
A: Observation. Patients are observed without treatment until relapse occurs.
B: CAPOX therapy. Patients receive 8 courses of CAPOX therapy (capecitabine 2,000 mg/m2 day1-14, oxaliplatin 130 mg/m2 da
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven adenocarcinoma of which primary tumor is located in the duodenum, jejunum, or ileum (adenocarcinoma of the papilla of Vater is ineligible, but primary duodenal adenocarcinoma which histologically invade to the papilla of Vater is eligible). 2) R0 resection is achieved by small bowel resection, pancreaticoduodenectomy, or distal gastrectomy with regional lymph nodes dissection. 3) Lavage Cytology during surgery is negative, unknown, or unexamined (Only positive case is ineligible). 4) Pathological stage is stage I (T1bN0M0 or T2N0M0), stage II, or stage III. 5) Aged between 16 and 74 years 6) ECOG performance status (PS) of 0 or 1 7) Sufficient oral intake 8) No metastasis/relapse findings on chest CT and enhanced abdomen-pelvis CT/MRI performed within 84 days before registration. 9) No history of chemotherapy or radiotherapy for small bowel adenocartinoma. 10) No history of platinum usage (ex. cisplatin, carboplatin, oxaliplatin, nedaplatin). 11) From 28 days to 84 days after surgery 12) Sufficient organ function 13) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies 2) Active infection requiring systemic therapy. 3) Body temperature of 38 degrees Celsius or higher. 4) Female during pregnancy, within 28 days of postparturition, or during lactation. 5) Severe psychological disease. 6) Continuous systemic corticosteroid or immunosuppressant treatment. 7) Inflammatory bowel disease (ex. Crohn disease, ulcerative colitis) or malabsorption (ex. Celiac disease) requiring therapy. 8) Uncontrollable diabetes mellitus 9) Uncontrollable hypertension 10) Unstable angina pectoris, or history of myocardial infarction within 6 months. 11) Positive HIV antibody. 12) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, disease-free survival (DFS defined by JCOG), disease-free survival (DFS defined by IRCI), adverse events | — |
Countries
Japan
Contacts
Public ContactYoshitaka Honma
JCOG1502C Coordinating Office National Cancer Center Hospital Gastrointestinal Medical Oncology Division
Outcome results
None listed