Esophageal cancer Esophageal cancer
Conditions
Interventions
For chemoradiotherapy in primary or recurrent esophageal cancer, the radiation delivery method shall be hypofractionated. Specifically, the prescribed dose to 95% of the planned target volume (PTV) sh
Radiation Therapy
Sponsors
Yamashita Hideomi
Eligibility
Inclusion criteria
Inclusion criteria: Esophageal cancer patients diagnosed with stage I-IVA according to the UICC-TNM classification (9th edition) or stage IVB with supraclavicular lymph node metastasis only, using various imaging diagnostic methods (FDG-PET [PET/CT] is mandatory); or cases determined to require additional treatment after ESD; or patients with small-volume recurrent esophageal cancer at the primary site or thoracic/abdominal lymph node sites after subtotal resection, among whom: 1) Cases histologically confirmed as squamous cell carcinoma, adenocarcinoma, basaloid carcinoma, or a mixture thereof 2) Cases where the attending physician determined the patient was eligible for platinum-based chemoradiotherapy 3) Cases with pre-treatment blood tests showing KL-6 levels below 1000 U/mL 4) Cases where written informed consent was obtained from the patient
Exclusion criteria
Exclusion criteria: 1) Patients with active concurrent cancers considered to have a poorer prognosis than esophageal cancer 2) Patients who are pregnant, may be pregnant, or are breastfeeding 3) Patients who are deemed unable to understand the explanation of the trial 4) Patients deemed ineligible for this trial by the responsible physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two-year progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Control rate within the radiation field Overall survival (OS) Cancer-specific survival (CSS) Incidence rate of grade 3 or higher acute adverse events Cumulative incidence rate of grade 3 or higher late adverse events up to 2 years after the start of radiation therapy Quality of life assessment using FACT-E (Functional Assessment of Cancer Therapy-Esophageal) Radiation therapy completion rate | — |
Contacts
Public ContactMei Kono
The University of Tokyo Hospital
Outcome results
None listed