Rectal cancer of Stage II or III with T4 or lateral lymph node metastasis at the pre-operative diagnosis
Conditions
Interventions
1)S-1 at a dose of 80mg/m2/day orally in 2 divided doses for 5 days a week during radiotherapy 2) Weekly oxaliplatin at a dose of 40-60mg/m2 intravenously 3) Radiotherapy is delivered a total irradi
Sponsors
National cancer center hosital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed Rectum cancer (adenocarcinoma, mucinous carcinoma, signet-ring cell carcinoma, adenosquamous carcinoma) 2. Preoperative findings (Must meet all the conditions) i.Main lesion of the tumor is located at the Rs, Ra, Rb, or P ii. Lower tumor margin is below the peritoneal reflection iii. With lateral LN metastasis (internal iliac lymph nodes, obturator lymph nodes or common iliac lymph nodes (Shorter diameter of LN is less than 10 mm or more by pelvic CT or MRI)), or T4 3. No evidence of distant metastasis 4. age:20-75years old 5. ECOG PS:0 or 1 6. With or without target lesion by RECIST 7. Without prior anti-cancer therapy 8. Adequate oral intake 9. Adequate organ function 10.Written IC
Exclusion criteria
Exclusion criteria: 1. Suspected metastasis of external iliac lymph nodes, para-aortic lymph nodes, or inguinal lymph nodes by pelvic MRI. 2. Prior or synchronous invasive malignancy (expect carcinoma in situ or superficial carcinoma which is able to eradicate by local therapy) unless disease free for a minimum of 5 years 3. Evidence of active bacterial or fungal infection (existing fever above 38 degrees centigrade due to infection) 4. Previous history of severe drug-induced allergy 5. Need to treatment with flucytosine, atazanavir sulfate, or warfalin 6. Need systemic administration of corticosteroids 7. Evidence of positive hepatitis B virus surface antigen 8. Evidence of severe watery diarrhea 9. Evidence of uncontrolled diabetic mellitus 10. Evidence of uncontrolled hypertension 11. Need to intervention for heart disease according to the findings of electrocardiogram within the last 28 days 12. Myocardial infarction or unstable angina pectoris within the last 12 months 13. Major surgery within 4 weeks of study enrollment (other than diverting colostomy) 14. Severe comorbidity (ie, bowel paralysis, bowel obstruction, interstitial pneumotitis, pulmonary fibrosis, advanced emphysema, heart disease which is difficult to manage, renal failure, hepatic failure) 15. Pregnant or lactating and woman with childbearing potential who lacked effective contraception 16. Evidence of psychiatric disability interfering with enrollment to clinical trial 17.Patients judged inappropriate for this study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the MTD and RD of oxaliplatin | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, radiologic and pathologic tumor response, surgical morbidity | — |
Countries
Japan
Contacts
Public ContactMasayuki Ohue
Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Surgery
Outcome results
None listed