Phase
Condition
Rectal Cancer
Colon Cancer
Colorectal Cancer
Treatment
CAPOXIRI
CAPOX
SCRT
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The content of this research was fully explained, and written informed consent wasobtained from the subject.
Histologically confirmed rectal adenocarcinoma.
Radical resection is clinically possible without any distant metastases on imagingstudies.
Age of 18 years or older on the date of consent acquisition.
Eastern Cooperative Oncology Group (ECOG) PS 0-1 (PS 0 if aged 70 years or older onconsent acquisition date).
Inferior margin of the tumor is within 12 cm of the AV.
No prior tumor treatment.
No history of radiation therapy to the pelvis, including treatment for other cancertypes.
Cases with cT3-4N0M0*or T1-4N1-2M0 based on Union Internationale Contre le Cancer (UICC) 8th edition.
(*5 cm< AV ≤ 10 cm, T3a/bN0M0, extramural venous invasion (EMVI) -, mesorectalfascia (MRF) clear and 10 cm < AV ≤ 12 cm, T3a/bN0-1M0, EMVI-, MRF clear areeligible only for those who refused surgery)
UGT1A1 is wild-type or single heterozygous.
Criteria for major organ function within 28 days prior to enrollment. If there aremultiple test results within this period, the most recent one will be used, andblood transfusions and hematopoietic factor preparations will not be administeredwithin 14 days before the test date for measurements before registration.
Neutrophil count: ≥1,500/mm3
Platelet count: ≥10.0×10 4/mm3
Hemoglobin concentration: ≥9.0 g/dL
Total bilirubin: ≤2.0 mg/dL
Aspartate transaminase (AST): ≤100 IU/L or less
Alanine transaminase (ALT): ≤100 IU/L or less
Serum creatinine: Creatinine clearance ≥30 mL/min (by Cockcroft & Gaultformula)
Exclusion
Exclusion Criteria:
Extensive surgery (excluding colostomy and central venous port construction) within 4 weeks before starting protocol treatment.
Complications or history of severe lung disease (such as interstitial pneumonia,pulmonary fibrosis, and severe emphysema).
Colonic stent in place.
Contraindications for MRI such as cardiac pacemakers.
Serious comorbidities (such as heart failure, renal failure, liver failure,intestinal paralysis, intestinal obstruction, uncontrolled diabetes, and activeinflammatory bowel disease).
Patients with multiple active cancers (simultaneous multiple cancers or metachronousmultiple cancers with a disease-free interval of 5 years or less). However,carcinoma in situ or lesions equivalent to intramucosal carcinoma, which can becured by local treatment, are not treated as active multiple cancers.
Pregnant women, lactating women, positive pregnancy test, or unwillingness to usecontraception.
Hepatitis B surface (HBs) antigen positive or hepatitis C virus (HCV)antibody-positive. However, HCV-RNA-negative can be registered.
Have human immunodeficiency virus (HIV) infection.
MSI-high (MSI-H) or defective mismatch repair (dMMR) is known.
Unwilling to donate specimens for "Research on gene profiling and clinicalsignificance using clinical specimens from cancer patients" for whole-genomeanalysis based on the "Action Plan for Whole-Genome Analysis, etc." (CONDUCTORstudy).
Any other patients the principal investigator or co-investigator deems inappropriatefor study participation.
Study Design
Study Description
Connect with a study center
National Cancer Center Hospital East
Chiba,
JapanActive - Recruiting
Ehime Prefectural Central Hospital
Ehime,
JapanActive - Recruiting
Kyushu University Hospital
Fukuoka,
JapanActive - Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka,
JapanActive - Recruiting
National Hospital Organization Kyushu Medical Center
Fukuoka,
JapanActive - Recruiting
Gifu University Hospital
Gifu,
JapanActive - Recruiting
Hirosaki University Hospital
Hirosaki,
JapanActive - Recruiting
Hiroshima University Hospital
Hiroshima,
JapanActive - Recruiting
St. Marianna University Hospital
Kawasaki,
JapanActive - Recruiting
University of Occupational and Environmental Health Hospital
Kitakyushu,
JapanActive - Recruiting
Kochi Medical School Hospital
Kochi,
JapanActive - Recruiting
Kumamoto University Hospital
Kumamoto,
JapanActive - Recruiting
Nagoya University Hospital
Nagoya,
JapanActive - Recruiting
Ohara Memorial Kurashiki Central Medical Organization Kurashiki Central Hospital
Okayama,
JapanActive - Recruiting
Okayama University Hospital
Okayama,
JapanActive - Recruiting
Kansai Medical University Hospital
Osaka,
JapanActive - Recruiting
Kindai University Hospital
Osaka,
JapanActive - Recruiting
National Hospital Organization Osaka Medical Center
Osaka,
JapanActive - Recruiting
Osaka International Cancer Institute
Osaka,
JapanActive - Recruiting
Osaka Prefectural Hospital Organization Osaka Acute and General Medical Center
Osaka,
JapanActive - Recruiting
Osaka University Hospital
Osaka,
JapanActive - Recruiting
Kitasato University Hospital
Sagamihara,
JapanActive - Recruiting
Sapporo Medical University Hospital
Sapporo,
JapanActive - Recruiting
Shizuoka Cancer Center
Shizuoka,
JapanSite Not Available
Foundation for Cancer Research Ariake Hospital
Tokyo,
JapanActive - Recruiting
Keio University Hospital
Tokyo,
JapanActive - Recruiting
National Cancer Center Hospital
Tokyo,
JapanActive - Recruiting
Nippon Medical School Hospital
Tokyo,
JapanActive - Recruiting
Tokyo Medical University Hospital
Tokyo,
JapanActive - Recruiting
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Komagome Hospital
Tokyo,
JapanActive - Recruiting
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama,
JapanActive - Recruiting
Yokohama City University Hospital
Yokohama,
JapanActive - Recruiting
Yokohama City University Medical Center
Yokohama,
JapanActive - Recruiting
Federation of National Public Service Personnel Mutual Aid Associations Yokosuka Mutual Aid Hospital
Yokosuka,
JapanActive - Recruiting
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