Phase I radiaition dose escalation study of intensity-modulated radiotherapy with end-exhalation breath-hold technique, combined with full-dose gemcitabine for patients with locally advanced pancreatic cancer.
- Conditions
- Pancreatic cancer
- Registration Number
- JPRN-UMIN000004589
- Lead Sponsor
- Department of Therapeutic Radiology, Kyoto University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 18
Not provided
1) Patients with active double cancer (double cancer with no more than 5-year disease-free period. However, carcinoma in situ judged to be cured by local treatment, or intra-mucosal cancer-equivalent lesion are not to be included in active double cancer). 2) Patients with active bacterial infection requiring treatment. 3) Patients with severe cardiac disease 4) Patients with severe drug allergy history 5) Patients with unstable and uncontrollable diabetic mellitus, hypertension, kidney disease, liver disease. 6) Patients with intersitial pneumonia or pulmonary fibrosis detectable on chest radiography 7) Women during pregnancy or breast-feeding, or patients who wish pregnancy 8) Patients that physicians consider inappropriate for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety (the incidence of dose limiting toxicity)
- Secondary Outcome Measures
Name Time Method ocal control rate, overall survival time, progression-free survival time, completion rate of chemotherapy, incidence of adverse events within 6 months from the start day of treatment, Rate of palliative efficacy (pain relief), rate of CA19-9 regression, The accuracy of the new technique of radiotherapy