Initially locally advanced unresectable pancreatic cancer after chemotherapy followed by carbon-ion radiotherapy with favorable response
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pre-treatment histological or cytological confirmation of malignancy. 2. Radiologically diagnosed as pancreatic ductal adenocarcinoma before treatment. 3. Unresectable locally-advanced (UR-LA) or Borderline resectable with arterial abutment (BR-A), confirmed by CT-imaging before treatment. 4. No obvious distant metastatic findings. 5. More than 4 months chemotherapy for pancreatic cancer. 6. Carbon ion radiotherapy after chemotherapy described above 5. 7. Disease control after more than 6 months treatment (RECIST=CR, PR, SD). 8. Serum tumor marker decrease after more than 6 months treatment. 9. No distant metastases by staging laparoscopy, including positive peritoneal lavage cytology. 10. Performance status is 0 or 1 (ECOG). 11. No serious comorbidity. 12. No active and ongoing other malignancy. 13. Able to eat orally 14. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. No pre-treatment histological or cytological confirmation of malignancy. 2. Resectable (R) or Borderline resectable without arterial abutment (BR-PV), confirmed by CT-imaging before treatment. 3. Obvious distant metastatic findings. 4. Less than 4 months chemotherapy. 5. No treatment with carbon ion radiotherapy. 6. Without disease control after treatment (RECIST=PD). 7. Serum tumor marker increase after treatment. 8. Distant metastases detected staging laparoscopy after treatment, including positive peritoneal lavage cytology. 9. Performance status is 2 or 3 (ECOG). 10. Serious comorbidity. 11. Active and ongoing other malignancy. 12. Unable to eat orally
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative morbidity rate with severe complication and mortality rate | — |
Countries
Japan
Contacts
Yamagata University Department of Surgery I