Evaluating the effects of prophylactic irradiation in esophageal cancer treatment

A Randomized Controlled Phase III Trial of Comparing Local Field With Additional Prophylactic Irradiation in Chemoradiotherapy for Clinical-T1bN0M0 Esophageal Cancer

This study tests if a new treatment combining chemotherapy and radiation can help people with esophageal cancer avoid the cancer coming back while keeping their esophagus and improving survival.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: National Cancer Center, Japan (Government)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tokyo)
• Trial ID: NCT04328948 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 20 and older with histologically proven cT1bN0M0 esophageal squamous cell carcinoma.

Not a fit: Patients with a history of prior therapies for esophageal cancer or those with advanced disease not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with esophageal squamous cell carcinoma by reducing recurrence rates.

How similar studies have performed: Other studies have shown promise with similar approaches in treating esophageal cancer, indicating potential for success.

Eligibility criteria

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 this trial is running

Tokyo

• National Cancer Center Hospital — Tokyo, Japan (Recruiting)

Study contacts

• Study coordinator: Motoo Nomura, MD/PhD

Conditions Esophageal Squamous Cell Carcinoma; Esophageal squamous cell carcinoma; chemoradiotherapy; Radiation Field