retroperitoneal/pelvic malignancy
Conditions
Interventions
To keep the bowel away from the radiation field, the adipose tissue in the abdominal cavity or superimposed Gore-Tex sheets will be placed onto the tumor as a spacer.
Sponsors
Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Malignant tumor proven histologically or diagnosed by imaging modalities. 2. Tumor in the retroperitoneum or pelvis. 3. Unresectable tumor or the patient denies surgical removal. 4. Tumor contiguous with the bowel less than 5mm in distance. 5. No unmanageable distant metastases. 6. ECOG PS 0-2. 7. Age 20-75. 8. Adequate organ function to perform the surgery. 9. Over three months of apparent survival. 10. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Tumor with over 15cm in the maximum diameter. 2. Without indication for carbon ion radiotherapy. 3. Infectious disease in abdominal or pelvic cavity. 4. Serious co-morbidity, such as cardiopulmonary disease, bleeding tendency, uncontrollable diabetes mellitus or hypertension. 5. Pregnant or possibly pregnant women. 6. Other conditions judged ineligible by physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative and postoperative morbidity rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment rate of carbon ion radiotherapy, Spacer placement rate, Operative time, Blood loss, Three year local control rate, Three year overall survival rate | — |
Countries
Japan
Contacts
Public ContactTatsuya Manabe,MD
Graduate School of Medical Sciences, Kyushu University Surgery and Oncology
Outcome results
None listed