Safety of preoperative short-term chemoradiotherapy with S-1/CPT-11 (Irinotecan) and total neoadjuvant therapy with consolidation chemotherapy with CapeOX for locally advanced rectal cancer: a phase I clinical study - SHOW TIME study

aitoh Takeshi0 个研究点目标入组 34 人开始时间: 2021年11月30日最近更新: 2023年10月17日

试验速览

暂无简介。

•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.

•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.

发起方

aitoh Takeshi