Actively Recruiting
A Randomized Controlled Trial Evaluating of Prophylactic Irradiation in CRT for cT1bN0M0 ESCC
Led by National Cancer Center, Japan · Updated on 2025-05-22
280
Participants Needed
1
Research Sites
508 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is conducted to investigate whether modified chemoradiotherapy with elective nodal irradiation reduces the locoregional recurrence that cannot be completely resected by salvage endoscopic resection and preserve esophagus without compromising overall survival.
CONDITIONS
Official Title
A Randomized Controlled Trial Evaluating of Prophylactic Irradiation in CRT for cT1bN0M0 ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma
- All lesions located in the thoracic esophagus; secondary lesions eligible for endoscopic resection
- Clinical N0M0 status confirmed by cervical to abdominal contrast-enhanced CT
- Deepest lesion clinically diagnosed as cT1b (SM1/SM2/SM3) by upper gastrointestinal endoscopy
- Age 20 years or older
- ECOG Performance status of 0 or 1
- No previous treatments against esophageal cancer except complete resection by EMR/ESD with specific disease conditions
- No history of radiotherapy to neck, chest, or upper abdomen; no chemotherapy or hormone therapy within 3 years disease-free interval
- Major organ functions preserved meeting specified blood and oxygen levels
- No preference for surgical resection as initial therapy after explanation
- Written informed consent obtained
You will not qualify if you...
- Simultaneous or metachronous double cancers within 5 years, except intramucosal tumors curable with local therapy
- Active infection requiring systemic therapy
- Fever over 38 degrees Celsius
- Female who is pregnant, within 28 days post parturition, or lactating; male desiring partner pregnancy
- Psychological disorders impairing study participation
- Receiving continuous systemic corticosteroid or immunosuppressant therapy
- Positive for hepatitis B surface antigen or HIV antigen
- Uncontrolled diabetes mellitus requiring insulin or hypoglycemic agents
- Uncontrolled arterial hypertension
- Recent unstable angina (within 3 weeks) or myocardial infarction (within 6 months)
- Uncontrolled valvular disease, dilated or hypertrophic cardiomyopathy
- Severe emphysema, interstitial pneumonia, or pulmonary fibrosis on chest CT
- History of cerebrovascular disorder within 6 months
- Allergy to iodic drugs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Center Hospital
Tokyo, Japan
Actively Recruiting
Research Team
M
Motoo Nomura, 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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