Patients with intraperitoneal or intrapelvic malignancies where the adjacent digestive tract made it difficult to perform particle radiation therapy and the spaces are required between malignancies and the digestive tract in the absence of effective therapies other than particle radiation therapy.
Conditions
Interventions
Intervention type:DEVICE
Name of intervention:Implant
Dose form / Japanese Medical Device Nomenclature:DEVICE
Route of administration / Site of application:IMPLANT
Dose per administration:
Dosing freq
Sponsors
Alfresa Pharma Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who were diagnosed with malignancies by diagnostic imaging or by histological diagnosis (2) Patients with malignancies which were localized and without other sites of disease (distant disease) (3) Patients with malignancies where the KHKA-01 can be surgically placed in the space between the margin of malignancies and normal tissues (4) Patients with performance status of 0, 1, and 2 (5) Patients who can maintain posture (the supine position for about 30 minutes) (6) Patients who can write consent of the patient about participation of this trial
Exclusion criteria
Exclusion criteria: 1) Patients meeting any of the following exclusion criteria on the initial visit day are excluded from study participation (1) Patients with a history of radiation therapy to these malignancies or who are planned to undergo additional radiation therapy to the same site as in this study from 28 days prior to surgery to the end of observation at Week 4 after the end of radiation (2) Patients with active and refractory infection at the radiation site (3) Patients with active double cancer (4) Patients with peptic ulcer in the planned irradiated volume (5) Patients with life expectancy of less than 12 months on the initial visit day (6) Patients on chemotherapy, immunotherapy and others or who are planned to undergo chemotherapy, immunotherapy, surgery, ablation treatment, and others from 28 days prior to surgery to the end of observation at Week 4 after the end of radiation (7) Patients with serious hepatic and renal dysfunction (about grade 2 of classification of the severity of adverse drug reactions) However, the exclusion criteria are not applied if the malignancies in this study affect the liver or kidney (8) Patients with mental disorder who cannot follow the protocol, patients with alcoholism and patients with drug dependence (9) Women who are pregnant or may be pregnant, women who are breastfeeding, women in disagree with birth control during clinical trial period (10) Men in disagree with birth control during clinical trial period (11) Patients participating in other clinical trials or patients who had participated in other clinical trials within the 6 months prior to commencement of a clinical trial (12) Patients who were considered inappropriate for study entry by the investigator or subinvestigators 2)Patients meeting any of the following exclusion criteria on the day of surgery using the KHKA-01 (1) Patients whose malignancies can be curatively resected. (2) Patients with malignancies at other sites away from the planned radiation site (3) Patients with malignancies where the KHKA-01 cannot be surgically placed in the space between the margin of malignancies and the digestive tract (at risk of severe adhesion, invasion, and dissemination) (4) Patients with active and refractory infection at the radiation site (5) Patients with active double cancer (6) Patients with peptic ulcer in the planned irradiated volume (7) Patients who had underwent chemotherapy, immunotherapy, radiation therapy, surgery, ablation treatment, and others within 28 days prior to surgery for the treatment of malignancies (8) Patients who were considered inappropriate for study entry by the investigator or subinvestigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The dose in critical organs calculated from Dose Volume Histogram (DVH), and the dose in malignancies 2. The thickness and volume of the KHKA-01 | — |
Countries
Japan
Contacts
Public ContactYasuo Sasai
Alfresa Pharma Corporation
Outcome results
None listed