Esophageal Squamous Cell Carcinoma
Conditions
Keywords
Esophageal squamous cell carcinoma, chemoradiotherapy, Radiation Field
Brief summary
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.
Interventions
RADIATIONChemoradiotherapy
Chemoradiotherapy
Sponsors
National Cancer Center, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major progression-free survival | The primary analysis will be held 5-years after the last patient was enrolled. | If the remnant lesion in the esophagus or a recurrent lesion after complete response (CR) can be curatively removed by salvage EMR/ESD, it is not an event, and other progressions and deaths are events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | The primary analysis will be held 5-years after the last patient was enrolled. | From date of randomization to date of progression or death, whichever occurs first, approximately 5 years. |
| Complete response rate | The primary analysis will be held 5-years after the last patient was enrolled. | CR was defined as disappeared primary tumors without the presence of ulceration or malignant cells in biopsy specimens under endoscopy. |
| Overall survival | The primary analysis will be held 5-years after the last patient was enrolled. | From date of randomization to date of death, approximately 5 years. |
| Adverse events | The primary analysis will be held 5-years after the last patient was enrolled. | Number of participants with treatment-related adverse events during CRT as assessed by CTCAE v4.0 |
| Long term toxicity | The primary analysis will be held 5-years after the last patient was enrolled. | Number of participants with treatment-related adverse events after termination of CRT as assessed by CTCAE v4.0 |
| Esophagectomy-free survival | The primary analysis will be held 5-years after the last patient was enrolled. | From date of randomization to date of esophagectomy or death, whichever occurs first, approximately 5 years. |
Countries
Japan
Contacts
Primary ContactMotoo Nomura, MD/PhD
Outcome results
None listed