Pediatric solid malignant tumo
Conditions
Interventions
Spacer replacement
Sponsors
Nagoya City University Graduate School of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with pediatric malignant solid tumor in abdominal or pelvic cavity. 2) The regions are limited and controlled. 3) Patients can be surgically replaced with PGA-spacer between the tumor and normal organ. 4) Patient age 30days or over 30 days and under 20 years. 5) Patients who can receive particle beam irradiation after PGA-spacer replacement. 6) Patients should obtain written consent if they are 16 years old or older. If they are under 16 years old, their proxies could do that for participation in this study.
Exclusion criteria
Exclusion criteria: 1) Patients with active and refractory infection at their irradiated site 2) Patients who have digestive ulcer at the site of irradiation. 3) Patients with severe liver or kidney disfunction 4) Patients who are pregnant, breast-feeding, or cannot agree with contraception during this study. 5) Patients who have PAG allergy. 6) Patients who are judged inappropriate by the researcher in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequencies of non-hematological toxicity greater than grade 3 by CTCAE criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Proton beam treatment completion rate 2) Spacer withdrawal rate 3) Dose volume distribution 4) Change of extension of treatment period | — |
Countries
Japan
Contacts
Public ContactMichi KAMEI
Nagoya City University Graduate School of Medical Sciences Department of Neonatology and Pediatrics
Outcome results
None listed