early stage intramucosal Carcinoma
Conditions
Interventions
APC therapy will be administered to study subjects with early stage intramucosal Carcinoma who are considered intolerant to EMR or ESD, and the local complete response rate, local recurrence-free surv
Sponsors
Ono Shouko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Early gastric cancer with cT1a-EP/LPM wall depth based on diagnostic endoscopic examination. Simultaneous or heterochronic multiple lesions are acceptable. Patients with or without a history of radiotherapy, chemotherapy, or endocrine therapy to the chest, or abdomen, including treatments for other carcinomas. 2) The following conditions (a) and (b) are diagnosed by endoscopy. Biopsy at the patient's registered facility is not required as long as the histological type can be confirmed by a specimen borrowed from a previous physician or a pathology report. (a)Patients diagnosed by endoscopic biopsy as having gastric adenocarcinoma, limited to common histological types such as papillary adenocarcinoma, well-differentiated tubular adenocarcinoma, or moderately differentiated tubular adenocarcinoma. Gastric biopsy specimens showing undifferentiated types, fundic gland-type gastric cancer, foveolar-type (raspberry), or mixed types wi th predominance of differentiated and undifferentiated components are excluded. (b)Patients with indications for early gastric cancer include lesions that are 2 cm or less, be classified as cT1a (M), and show no ulceration. However, lesions with ulceration may be included if the ulcer has undergone scarring. 3) No evidence of lymph node metastasis or dista nt metastasis (N0, M0) based on CT scan (contrast -enhanced is recommended). 4) Patients who are judged to have difficulty performing surgical treatment (surgery), EMR,or ESD 5) Patients who has any of the following (a) to (e) (a)Patients with a Charlson comorbidity index of 3 or higher (b)Patients who have comorbidities that require antithrombotic medication and who fall into a group with a high incidence of thromboembolism due to drug discontinuation (c)Among patients with blood disorders, those with thrombocytopenia but having a platelet count of 30,000/microliter or higher (e)Patients persons receiving oxygen due to chronic respiratory failure (e)Patients who have had a history of endoscopic treatment in the past and have a test lesion in the scar area 6) ECOG Performance Status (PS) of 1 to 3 (excluding patients with PS score 4). An exception to this is that patients meeting inclusion criterion 5(e) are also eligible with a PS of 0. 7) Patients aged 20 years or older at the time of obtaining consent. 8) Patients for whom written consent has been obtained from the patient or his/her legal represe ntative regarding research participation.
Exclusion criteria
Exclusion criteria: 1) Patient diagnosed with gastric cancer who are eligible for surgical treatment (surgery). 2) Patient with active multiple primary cancers (simultaneous multiple primary cancers and iatrogenic multiple primary cancers with a disease-free interval of 5 years or less). However, even if the disease-free interval is less than 5 years, a history of cancer equivalent to a 5-year relative survival rate of 95% or more, such as clinical stage Iprostate cancer, clinical stage 0 or stage I laryngeal cancer with complete response to radiotherapy, or completely resected cancers of the following stages is not considered active multiple primary cancer: 3) Patients with infectious diseases requiring systemic treatment. 4) Patients with a fever of 38 degrees Celsius or higher at the time of registration. 5) Patients with psychiatric disorders or psychiatri c symptoms that interfere with daily life and make it difficult to participate in the study. 6) Patients with hematologic malignancies (leukemia, malignant lymphoma, multiple myeloma) in the active stage of hematologic disease. 7) Patients with NYHA classification III or IV chronic heart failure and those with poorly controlled he art failure. 8) Patients diagnosed with chronic respiratory failure and on non-invasive positive pressure ventilation (NPPV). However, patients on home oxygen therapy are excluded. 9) Pregnant or lactating mothers. 10) Patients who are deemed inappropriate for inclusion in the study by the principal investigator or subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local complete response (L-CR) after 12 weeks from the argon plasma coagulation therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Local relapse free survival: L-RFS 2) Relapse free survival: RFS 3) Overall survival: OS 4) Changes of Instrumental Activities of Daily Living: IADL 5) Safety: Evaluate the incidence of the adverse events | — |
Contacts
Public ContactYusuke Watanabe
Hokkaido University Hospital
Outcome results
None listed