Esophageal Cancer Esophageal Cancer
Conditions
Interventions
Carbon-ion radiotherapy is performed for patients who require additional treatment after ESD for esophageal cancer.
Sponsors
Isozaki Tetsuro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Persons aged 18 years or older at the time ofobtaining consent. Gender is not a consideration. 2) Patients with histologically diagnosed primary squamous cell carcinoma of the thoracic esophagus after endoscopic submucosal dissection (ESD). 3) Patients with histologically diagnosed pT1a-MM or pT1b in 2) and negative resection margins. 4) Patients who have been determined to have nometastasis of esophageal cancer based on imaging tests using CT and PET before carbon-ion radiotherapy. 5) Patients who have no active ulcers in the esophagus before carbon-ion radiotherapy, and whose ulcers have healed and scarred after ESD. 6) Patients who are not indicated for or do not wish to undergo additional surgical resection or X-ray-based chemoradiotherapy for esophageal cancer. 7) Patients with a performance status (ECOG) of 0-2. 8) Those who have no history of prior surgical resection for esophageal disease. 9) Those who are estimated to have a life expectancy of more than 6 months. 10) Those who have obtained written consent from the patient regarding participation in this clinical study. 11) Cases in which consent was obtained for this study within 70 days of the completion of ESD.
Exclusion criteria
Exclusion criteria: 1) Those whose ulcer surface has become full-circumferential due to ESD. 2) Those who have had local steroid injections into the ulcer after ESD. 3) Those who have active and intractable infection in the irradiated area. 4) Those who have a history of radiation therapy in the irradiated area. 5) Those who are judged to be unable to participate in this study for medical or psychological reasons. 6) Those who are pregnant or may be pregnant, or who are breastfeeding. 7) Other people who the principal investigator or other staff members judge to be unsuitable as subjects for this clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events of Grade 3 or higher within 90 days of carbon-ion radiotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| All adverse events within 180 days of carbon-ion radiotherapy, recurrence-free survival, overall survival | — |
Contacts
Public ContactTetsuro Isozaki
National Institutes for Quantum Science and Technology
Outcome results
None listed