Rectal cancer
Conditions
Interventions
Preoperative chemoradiotherapy using S-1/CPT-11/enhanced chemotherapy using CAPOX
(Phase I study 1)
- Chemoradiotherapy will last for 14 days.
- Irradiation will be 5 Gy/day in 5 divided doses (5 days
Sponsors
Naitoh Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed rectal cancer (adenocarcinoma) 2. Patients who meet all of the following criteria on imaging diagnosis* within 28 days prior to enrollment -Resectable cases with the diagnosis of cT3-4 and N0-2 -The primary site of occupation is either Ra or Rb. -The inferior border of the tumor is anorectal to the peritoneal adaptation. -No obvious lateral lymph node metastasis -No gross type 4 (diffuse invasive type) 3. No liver metastasis, peritoneal metastasis, or distant metastasis. 4. Age between 20 and 80 (full age) at the time of registration. 5. Patients who have not received any prior treatment (radiotherapy, chemotherapy, hormone therapy, etc.) for the disease 6. Patients with no severe impairment of major organ function (bone marrow, liver, kidney, etc.) 7. No clinically problematic findings on electrocardiogram within 28 days prior to enrollment 8. Patients with a general performance status (P.S.) of 0-1. 9. Patients who are able to eat and take drugs orally. 10. Patients whose consent to be a subject of this study has been explained to them using a consent explanation document and their written consent has been obtained.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of severe drug hypersensitivity 2. Patients with active multiple cancers or multiple colorectal cancer 3. Patients receiving flucytosine or atazanavir sulfate 4. Patients with UGT1A1*6/*6, UGT1A1*28/*28 and both heterozygous (UGT1A1*6/*28) 5. Patients with active infection 6. Patients with serious complications 7. Patients with a history of interstitial pneumonia 8. Patients with pleural effusion or ascites requiring treatment 9. Patients with fresh bleeding in the gastrointestinal tract 10. Patients with diarrhea (watery stool) 11. Women with the possibility (intention) of pregnancy, pregnant women, or lactating women who do not intend to use contraception. 12. Cases receiving continuous systemic administration of steroids (oral or intravenous). 13. Cases with HBs antigen positive. 14. Patients with contraindication to administration of S-1 and CPT-11. 15. Other patients who are judged by the investigator to be unsuitable for enrollment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I Study 1: Estimation of the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 and CPT-11 Phase I study 2: Incidence of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I study (1): Safety (Incidence of adverse events, Complication rate), R0 resection rate, Down-staging rate, pCR rate, Grade determination of treatment effect Phase I (2): Completion rate of intensified chemotherapy, Surgical outcomes (Operative time, Blood loss, R0 resection rate, CRM, Postoperative hospital stay, Anal sphincter preservation rate, Autonomic nerve preservation rate, Complication rate), Down-staging rate, Recurrence-free survival (RFS), Overall survival (OS), Cumulative local recurrence rate, Evaluation of the relationship between nutritional indices and adverse events, Perioperative complications, and prognosis, Rate of clinical complete response, Rate of transition to watch-and-wait approach | — |
Contacts
Public ContactKen Kojo
Kitasato University
Outcome results
None listed