Actively Recruiting
A Randomized Controlled Phase III Trial Comparing Local Field With Additional Prophylactic Irradiation in Chemoradiotherapy for Clinical-T1bN0M0 Esophageal Cancer
Led by National Cancer Center, Japan · Updated on 2025-05-22
280
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether modified chemoradiotherapy with elective nodal irradiation can reduce locoregional recurrence in patients with clinical T1bN0M0 esophageal squamous cell carcinoma that cannot be fully removed by salvage endoscopic resection, while preserving the esophagus without affecting overall survival. This is a randomized controlled Phase III trial focused on this specific stage of esophageal cancer. The trial compares two chemoradiotherapy regimens: one with elective nodal irradiation and one with involved field irradiation. Both use chemotherapy drugs 5-FU and CDDP given on specified days, combined with radiotherapy delivered in fractions totaling either 50.4 Gy or 60 Gy. The study aims to assess the impact of adding prophylactic irradiation to the standard local field treatment. Participants will undergo clinical evaluations including imaging and endoscopy to diagnose and monitor the cancer. Major outcomes measured include progression-free survival, overall survival, complete response rate, esophagectomy-free survival, adverse events, and long-term toxicity. The primary analysis will occur five years after the last patient enrollment, allowing comprehensive monitoring of treatment effects and safety over time.
CONDITIONS
Brief 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 proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.
- All lesions located in the thoracic esophagus; secondary lesions eligible if treatable by endoscopic resection.
- Clinical N0M0 confirmed by cervical to abdominal contrast-enhanced CT.
- Deepest lesion diagnosed as clinical T1b stage by upper gastrointestinal endoscopy.
- Age 20 years or older.
- ECOG Performance status of 0 or 1.
- No previous therapy against esophageal cancer except complete resection by EMR/ESD for specific early-stage disease.
- No history of radiotherapy to neck, chest, or upper abdomen; no recent chemotherapy or hormone therapy for any cancers.
- Preserved major organ function as defined by specific blood and organ function test thresholds.
- No preference for surgical resection as initial therapy after explanation.
- Written informed consent obtained.
You will not qualify if you...
- Presence of simultaneous or recent (within 5 years) double cancers, except intramucosal tumors curable with local therapy.
- Active infection requiring systemic therapy.
- Fever over 38 degrees Celsius.
- Pregnancy, recent childbirth, or lactation; males wishing to conceive.
- Psychological disorders interfering with study participation.
- Continuous use of systemic corticosteroids or immunosuppressants.
- Positive for hepatitis B surface antigen or HIV antigen.
- Uncontrolled diabetes requiring continuous insulin or medication.
- Uncontrolled high blood pressure.
- Recent unstable angina or heart attack.
- Uncontrolled valvular heart disease or cardiomyopathy.
- Severe lung diseases such as emphysema or pulmonary fibrosis.
- Recent cerebrovascular disorder within 6 months.
- Allergy to iodic drugs.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 to 5 weeks
Participants receive chemoradiotherapy consisting of chemotherapy with 5-FU and CDDP combined with radiotherapy.
Multiple visits during chemoradiotherapy treatment period
Duration - Up to 5 years
Participants are monitored for survival, disease progression, response to treatment, adverse events, and long-term toxicity for up to 5 years after treatment.
Periodic follow-up visits as scheduled
Trial Site Locations
Total: 1 location
1
National Cancer Center Hospital
Tokyo, Japan
Actively Recruiting
Research Team
M
Motoo Nomura, MD/PhD
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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