Evaluating the effects of prophylactic irradiation in esophageal cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of modified chemoradiotherapy with elective nodal irradiation in patients with esophageal squamous cell carcinoma. The goal is to determine if this approach can reduce locoregional recurrence in cases where complete resection is not possible, while also preserving the esophagus and maintaining overall survival rates. Participants will receive chemoradiotherapy as part of the intervention. The study focuses on patients with specific tumor characteristics and staging.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.
2. All lesions located in the thoracic esophagus. Secondary lesions with an absolute indication for endoscopic resection (EMR/ESD) may not be confined to the thoracic esophagus.
3. Clinical N0M0 with cervical to abdominal contrast-enhanced CT.
4. The deepest lesion is diagnosed as cT1b (SM1 / SM2 / SM3) with upper gastrointestinal endoscopy. If it is difficult to differentiate cT1a-MM and cT1b-SM1 clinically, the wall depth is diagnosed as cT1b-SM1.
5. Aged 20 years and older.
6. ECOG Performance status 0 or 1.
7. No previous therapy against esophageal cancer except for complete resection by EMR/ESD with either pT1a-LPM (pM2) / pT1a-MM (M3) disease or pT1a-MM (M3) disease without vascular infiltration.
8. No history of radiotherapy for the neck, chest, and upper abdomen for any cancers. No chemotherapy or hormone therapy with less than 3 years of disease-free interval for any cancers.
9. Major organ function is preserved. 1) WBC\<=12,000/mm3 2) ANC\>=1,500/mm3 3) Hb\>=10.0 g /dL 4) PLT\>=10,000/mm3 5) T-bil\<=1.5 mg /dL 6) AST\<=100 IU/L 7) ALT\<=100 IU/L 8) SpO2\>=95% 9) Ccr\>=60 mL/min
10. Patients do not have a preference to receive a surgical resection as an initial therapy after receiving explanations.
11. Written informed consent is obtained.

Exclusion criteria:

1. Simultaneous or metachronous (within 5 years) double cancers, except for intramucosal tumor curable with local therapy.
2. Active infection requiring systemic therapy.
3. Fever over 38 degrees Celsius
4. Female during pregnancy, within 28 days of post parturition, or during lactation. Male who wants a partner's pregnancy.
5. Psychological disorder, which is difficult to participate in this clinical study.
6. Receiving continuous systemic corticosteroid or immunosuppressant treatment.
7. Positive for HBs antigen or HIV antigen.
8. Diabetes mellitus, which is uncontrollable with continuous use of insulin or hypoglycemic agents.
9. Uncontrolled arterial hypertension.
10. History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
11. Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
12. Severe emphysema, interstitial pneumonia or pulmonary fibrosis based on chest CT.
13. With a history of cerebrovascular disorder within 6 months.
14. Drug allergy for iodic drugs.

Where it's running

• National Cancer Center Hospital
  Tokyo, Japan Recruiting

Study contacts

• Study coordinator: Motoo Nomura, MD/PhD
• Email: mnomura@kuhp.kyoto-u.ac.jp
• Phone: 81335422511

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Neoadjuvant Cardonilizumab With Chemotherapy Before Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma

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• Surgery or chemoradiotherapy after neoadjuvant immunochemotherapy for esophageal squamous cell carcinoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.