Locally advanced resectable rectal cancer
Conditions
Interventions
S-1(80-120mg/body/day1-5,8-12,22-26,29-33) CPT-11(60mg/m2/day1,8,22,29) Radiotherapy(1.8Gy/ 5 times a week for 5 weeks,45Gy/total)
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 (longest diameter is less than 10 mm) (v) Not type 4(Diffuse Infiltrative Type) 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. Oral intake possible 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 administration of corticosteroids 13. Patients of hepatitis B virus suface antigen positivity 14.Contraindication of S-1or CPT-11 15. Patients judged inappropriate for this study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological Complete Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse free survival (RFS) Overall survival (OS) Rate of local recurrence Completion rate of neoadjuvant chemoradiation therapy R0 resection rate Down-staging rate Safety Relation between a nutrition index, and adverse event, perioperative complications and prognosis | — |
Countries
Japan
Contacts
Public ContactSAMRAI affairs office
The Tokyo Cooperative Oncology Group Clinical Study Promotion Agency
Outcome results
None listed