ENSEMBLE
- Conditions
- ocally advanced rectal cancer
- Registration Number
- JPRN-jRCTs031220342
- Lead Sponsor
- Yoshino Takayuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 608
(1) The subject has been fully informed of the details of the study and his/her written consent has been obtained.
(2) Adenocarcinoma confirmed by histological examination.
(3) No distant metastasis is identified on imaging examination, and radical resection is clinically feasible.
(4) Subject is at least 18 years of age on the date of consent.
(5) ECOG Performance Status (PS) of 0 - 1
(PS 0 if the subject is 70 years of age or older on the date of consent).
(6) The lower margin of the tumor is within 12 cm of the anal verge (AV).
(7) No prior treatment for the tumor.
(8) No prior pelvic radiation therapy, including treatment for other types of cancer.
(9) Subjects with cT3-4N0M0 or T1-4N1-2M0 based on UICC 8th edition.
( For 5cm(10) UGT1A1 is wild type or single heterozygous.
(11) The following criteria for major organ function within 28 days prior to enrollment are met.
a. Neutrophil count >= 1500/mm3
b. Platelet count >=10.0 x 104 /mm3
c. Hemoglobin concentration >= 9.0 g/dL
d. Total bilirubin <= 2.0 mg/dl
e. AST: less than or equal to 100 IU/L
f. ALT: less than or equal to 100 IU/L
g. Serum creatinine: creatinine clearance>= 30 mL/min
(1) Subject has undergone extensive surgery within 4 weeks prior to the start of protocol treatment (excluding colostomy and central venous port).
(2) Complication or previous history of severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema, etc.).
(3) Colorectal stent implantation.
(4) Cardiac pacemaker or other contraindications to MRI.
(5) Subject has severe comorbidities (heart failure, renal failure, liver failure, intestinal paralysis, bowel obstruction, uncontrolled diabetes, active inflammatory bowel disease, etc.).
(6) Prior or concurrent malignancy < 5 years prior to enrolment in study
(7) Pregnant or lactating women, positive pregnancy test or unwillingness to use contraception.
(8) HBs antigen positive or HCV antibody positive. However, if the HCV-RNA is negative, the subject is eligible for enrollment.
(9) Known human immunodeficiency virus (HIV) infection.
(10) Known microsatellite instability - high (MSI-H) or deficient mismatch repair (dMMR).
(11) The applicant does not intend to consent to the Research on Genetic Profiling and Clinical Significance Using Clinical Specimens from Cancer Subjects (CONDUCTOR Study)
(12) The investigator or principal investigator judges that the subject is inappropriate for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method