Exploratory clinical trial to evaluate the feasibility and efficacy of conversion surgery after systemic chemotherapy followed by carbon ion radiotherapy against locally advanced unresectable pancreatic cancer
Not Applicable
Recruiting
- Conditions
- Initially locally advanced unresectable pancreatic cancer after chemotherapy followed by carbon-ion radiotherapy with favorable response
- Registration Number
- JPRN-UMIN000049457
- Lead Sponsor
- Faculty of Medicine, Yamagata University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative morbidity rate with severe complication and mortality rate
- Secondary Outcome Measures
Name Time Method