Actively Recruiting
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
Led by Osaka University ยท Updated on 2023-07-11
45
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combined preoperative treatment approach for patients with cT2 rectal cancer. This phase 2, multicenter, single-arm study aims to assess how well short-course radiation therapy followed by chemotherapy works before surgery. The goal is to improve treatment outcomes for patients with this specific stage of rectal cancer. The treatment includes a short course of radiation therapy delivered as five daily doses of 5 Gy each. After radiation, patients receive six cycles of a chemotherapy regimen called CAPOX, which combines oxaliplatin and capecitabine over several weeks. Following these preoperative therapies, patients undergo surgery involving total mesorectal excision with radical lymph node removal to address the cancer. Participants will be closely monitored throughout the study to evaluate the pathological complete response, which measures the absence of cancer cells after treatment. Assessments include imaging and laboratory tests, as well as evaluations of organ function before treatment begins. The study will continue for about six months on average, during which safety and treatment effects are carefully recorded to understand the benefits and risks of this combined therapy approach.
CONDITIONS
Brief 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...
- Patient has given written informed consent.
- Adenocarcinoma of the rectum confirmed by histology.
- No distant metastases; radical resection is clinically feasible.
- Age 20 years or older at consent.
- ECOG Performance Status 0-1 (PS 0 if age 71 or older).
- Previously untreated rectal cancer with tumor lower margin within 12 cm of anal verge.
- Diagnosed with cT2N0M0 rectal cancer before treatment.
- Meets specific lymph node metastasis criteria by imaging.
- Adequate major organ function within 14 days prior to registration (blood counts, liver and kidney function).
You will not qualify if you...
- Recent extensive surgery within 4 weeks (excluding CV port placement).
- Any anticancer therapy or radiation within 4 weeks prior to study therapy.
- Severe pulmonary disease such as interstitial pneumonia or emphysema.
- Presence of a colonic stent.
- Serious comorbidities including heart, renal, liver failure, bleeding ulcers, intestinal paralysis, bowel obstruction, poorly controlled diabetes.
- Active multiple overlapping cancers within 5 years (except certain curable carcinomas).
- Pregnant or lactating women, positive pregnancy test, or unwillingness to use contraception.
- Positive for HBs antigen or HCV antibody.
- Known HIV infection.
- Judged unsuitable by investigators for participation.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 4 to 5 months
Participants receive preoperative short-course radiation therapy followed by neoadjuvant chemotherapy and then surgery to treat cT2 rectal cancer.
Radiation therapy over 1 week, followed by 6 chemotherapy cycles each lasting 3 weeks, and then surgery
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
Y
Yoshinori Kagawa, MD, PhD
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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