Actively Recruiting
TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer
Led by National Cancer Center Hospital East · Updated on 2025-04-03
608
Participants Needed
34
Research Sites
423 weeks
Total Duration
On this page
Sponsors
N
National Cancer Center Hospital East
Lead Sponsor
J
Japan Agency for Medical Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial is a multicenter randomized Phase III study to verify the superiority of short-course preoperative radiation (SCRT) and CAPOXIRI over SCRT and CAPOX as preoperative treatments for locally advanced rectal cancer.
CONDITIONS
Official Title
TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent after full explanation of the study
- Histologically confirmed rectal adenocarcinoma
- Clinically possible radical resection without distant metastases on imaging
- Age 18 years or older at consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (PS 0 if age 70 or older)
- Tumor inferior margin within 12 cm of the anal verge
- No prior tumor treatment
- No prior pelvic radiation therapy
- Clinical stage cT3-4N0M0 or T1-4N1-2M0 based on UICC 8th edition, with specific conditions for certain subgroups
- UGT1A1 gene is wild-type or single heterozygous
- Adequate major organ function within 28 days before enrollment including neutrophil count ≥1500/mm3, platelet count ≥100,000/mm3, hemoglobin ≥9.0 g/dL, total bilirubin ≤2.0 mg/dL, AST and ALT ≤100 IU/L, and creatinine clearance ≥30 mL/min
You will not qualify if you...
- Extensive surgery (other than colostomy or central venous port) within 4 weeks before treatment
- Severe lung disease history such as interstitial pneumonia, pulmonary fibrosis, or severe emphysema
- Presence of colonic stent
- Contraindications for MRI including cardiac pacemakers
- Serious comorbidities like heart failure, renal failure, liver failure, intestinal paralysis or obstruction, uncontrolled diabetes, or active inflammatory bowel disease
- Multiple active cancers within 5 years, except certain localized carcinomas
- Pregnancy, lactation, positive pregnancy test, or unwillingness to use contraception
- Positive for hepatitis B surface antigen or hepatitis C antibody (except HCV-RNA negative)
- HIV infection
- Known MSI-high or defective mismatch repair status
- Unwillingness to donate specimens for gene profiling research
- Any other condition deemed inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 34 locations
1
National Cancer Center Hospital East
Chiba, Japan
Actively Recruiting
2
Ehime Prefectural Central Hospital
Ehime, Japan
Actively Recruiting
3
Kyushu University Hospital
Fukuoka, Japan
Actively Recruiting
4
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan
Actively Recruiting
5
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan
Actively Recruiting
6
Gifu University Hospital
Gifu, Japan
Actively Recruiting
7
Hirosaki University Hospital
Hirosaki, Japan
Actively Recruiting
8
Hiroshima University Hospital
Hiroshima, Japan
Actively Recruiting
9
St. Marianna University Hospital
Kawasaki, Japan
Actively Recruiting
10
University of Occupational and Environmental Health Hospital
Kitakyushu, Japan
Actively Recruiting
11
Kochi Medical School Hospital
Kochi, Japan
Actively Recruiting
12
Kumamoto University Hospital
Kumamoto, Japan
Actively Recruiting
13
Kyoto Prefectural University of Medicine
Kyoto, Japan
Actively Recruiting
14
Nagoya University Hospital
Nagoya, Japan
Actively Recruiting
15
Ohara Memorial Kurashiki Central Medical Organization Kurashiki Central Hospital
Okayama, Japan
Actively Recruiting
16
Okayama University Hospital
Okayama, Japan
Actively Recruiting
17
Kansai Medical University Hospital
Osaka, Japan
Actively Recruiting
18
Kindai University Hospital
Osaka, Japan
Actively Recruiting
19
National Hospital Organization Osaka Medical Center
Osaka, Japan
Actively Recruiting
20
Osaka International Cancer Institute
Osaka, Japan
Actively Recruiting
21
Osaka Metropolitan University Hospital
Osaka, Japan
Actively Recruiting
22
Osaka Prefectural Hospital Organization Osaka Acute and General Medical Center
Osaka, Japan
Actively Recruiting
23
Osaka University Hospital
Osaka, Japan
Actively Recruiting
24
Kitasato University Hospital
Sagamihara, Japan
Actively Recruiting
25
Sapporo Medical University Hospital
Sapporo, Japan
Actively Recruiting
26
Keio University Hospital
Tokyo, Japan
Actively Recruiting
27
National Cancer Center Hospital
Tokyo, Japan
Actively Recruiting
28
Nippon Medical School Hospital
Tokyo, Japan
Actively Recruiting
29
Tokyo Medical University Hospital
Tokyo, Japan
Actively Recruiting
30
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Komagome Hospital
Tokyo, Japan
Actively Recruiting
31
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Japan
Actively Recruiting
32
Yokohama City University Hospital
Yokohama, Japan
Actively Recruiting
33
Yokohama City University Medical Center
Yokohama, Japan
Actively Recruiting
34
Federation of National Public Service Personnel Mutual Aid Associations Yokosuka Mutual Aid Hospital
Yokosuka, Japan
Actively Recruiting
Research Team
Y
Yoshinori Kagawa, MD., PhD
CONTACT
J
Jun Watanabe, MD., PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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