Safety of short course chemoradiotherapy with S-1/CPT-11 and total neoadjuvant therapy with short course chemoradiotherapy and Capox for advanced rectal cancer
- Conditions
- Rectal cancer
- Registration Number
- JPRN-jRCTs031210461
- Lead Sponsor
- aitoh Takeshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 34
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method