Actively Recruiting
A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer
Led by Osaka University · Updated on 2023-07-11
45
Participants Needed
2
Research Sites
357 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multicenter single-arm phase 2 study to evaluate safety and efficacy of the total neoadjuvant therapy of short course radiation therapy followed by neoadjuvant oxaliplatin/fluorouracil-based chemotherapy (CAPOX) for cT2 rectal cancer
CONDITIONS
Official Title
A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient has given written informed consent to participate in the study.
- Histologically confirmed adenocarcinoma of the rectum.
- No distant metastases detected and radical resection is clinically possible.
- Age 20 years or older at the time of consent.
- ECOG Performance Status 0-1 (PS 0 if age 71 years or older).
- Previously untreated rectal cancer with lower tumor margin within 12 cm of the anal verge.
- Diagnosed with clinical stage cT2N0M0 rectal cancer before treatment.
- Lymph node metastasis criteria met based on imaging (CT or MRI) with specific size and characteristics.
- Adequate major organ function within 14 days prior to registration, including neutrophil count ≥1,500/mm3, platelet count ≥100,000/mm3, hemoglobin ≥9.0 g/dL, total bilirubin within 1.5 times institutional limit, AST/ALT/ALP ≤2.5 times institutional limit, and creatinine within 1.5 times institutional limit or creatinine clearance ≥45 mL/min.
You will not qualify if you...
- Underwent extensive surgery (except CV port placement) within 4 weeks before starting protocol therapy.
- Received any anticancer therapy within 4 weeks prior to protocol therapy.
- Received radiation therapy within 4 weeks prior to protocol therapy.
- Have severe pulmonary diseases such as interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
- Have a colonic stent implanted.
- Have serious comorbid conditions including heart failure, renal failure, liver failure, bleeding peptic ulcer, intestinal paralysis, bowel obstruction, or poorly controlled diabetes.
- Have active multiple overlapping cancers with a disease-free period of 5 years or less, excluding curable carcinoma in situ or intramucosal carcinoma.
- Are pregnant or lactating, have a positive pregnancy test, or unwilling to use contraception.
- Are positive for hepatitis B surface antigen or hepatitis C antibody.
- Have known human immunodeficiency virus (HIV) infection.
- Judged by the investigator to be unsuitable for this study.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Osaka General Medical Center
Osaka, Japan
Actively Recruiting
2
Osaka University Hospital
Osaka, Japan
Actively Recruiting
Research Team
M
Mamoru Uemura, MD, PhD
CONTACT
Y
Yoshinori Kagawa, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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