locally advanced resectable rectal cancer
Conditions
Interventions
TS-1:day1-5,8-12, 22-26,29-33 CPT-11:day1,8,22,29 Radiotherapy: 5 times a week for 5 weeks
Sponsors
The Tokyo Cooperative Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed Rectum adenocarcinoma 2. Preoperative findings i.The clinical stage is T3-4 and N0-2 ii.Main lesion of the tumor is located at the Ra or Rb iii.Lower tumor margin is below the peritoneal reflection iv.No extra mesorectal lymph node swelling (Shorter diameter is less than 10 mm) 3. No evidence of peritoneal metastasis, liver metastasis and distant metastasis 4. age:20-80years old 5. Without prior anti-tumor therapy 6. Adequate organ function 7. Normal ECG 8. Performance status 0-1 9. the case can eat 10.Written IC
Exclusion criteria
Exclusion criteria: 1.Previous history of severe drug-induced allergy 2.Multiple malignancies to be treated or synchronous colorectal cancer 3.Need to treatment with flucytosine or atazanavir sulfate 4. Patient with homozygous genotype of UGT1A1*28/*28 or UGT1A1*6/*6, with combined heterozygous genotypes of UGT1A1*28 and UGT1A1*6 5. Active infections 6. Serious complications 7.Previous history of Interstitial Pneumonitis 8.Pleural effusion or ascites requiring treatment. 9. Active digestive tract bleeding 10. Severe watery diarrhea 11. Pregnant or nursing 12.Systemic administartion of corticosteroids 13. Patients of hepatitis B virus suface antigen positivity 14. Patients judged inappropriate for this study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose Recommended dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety R0 resection rate Down-staging rate pathological Complete Response rate | — |
Countries
Japan
Contacts
Public ContactSAMRAI affairs office
The Tokyo Cooperative Oncology Group Clinical Study Promotion Agency
Outcome results
None listed