borderline resectable pancreatic cancer
Conditions
Interventions
Case series:Neoadjuvant chemoradiation therapy
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 72 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Aged 18 - 72 Years 3. Histologically or cytologically proven adenocarcinoma of the pancreas. 4. Determination of borderline resectable pancreatic adenocarcinomadetermined by multiple disciplinary team (MDT) of Sun Yat-sen Cancer Center by review of a diagnostic CT scan and/or MRI scan with contrast, and defined according to the NCCN consensus guidelines. 5. Estimated life expectance > 3 months. 6. Patient can take medications orally. 7. Karnofsky performance status greater than or equal to 70 8. Lab Values: (1) Alanine transaminase (ALT) and aspartate transaminase (AST) /= 9.0 g/dL, neutrophils >/= 1,500/mm3, platelet count >/= 90,000/mm3 (3) Creatinine clearance >/= 60 mL/min.
Exclusion criteria
Exclusion criteria: 1. Received any of the following treatments prior to this clinical trial: 1) Prior chemotherapy; 2) Prior radiation therapy; 3) Administration of any other investigational agent within 30 days; 4) Any operation within 3 weeks; 5) Candidates for any other ongoing clinical trials; 2. Previous or current malignancies of other histologies; with the exception of adequately treated basal cell carcinoma of skin and cervical cancer in situ; 3.;Other serious illness or physical condition, including: 1) Patients with a history of severe heart disease, include congestive heart failure, high-risk uncontrolled arrhythmia and high blood pressure, angina pectoris needing pharmacotherapy and severe myocardial infarction; 2) Active infection or active infectious diseases; 3) Known gastrointestinal disorders, including dyspepsia, diarrhea, etc. at the beginning of the study; 4) Chronic nausea, vomiting or diarrhea which may interfere with the intake and absorption of oral investigational agent; 5) Uncontrolled diabetes mellitus; 4. Psychological disorders that would preclude appropriate informed consent or compliance with the study; 5. Any other acute or chronic unwell, laboratory abnormality that would increase the expected risk of the study, affect the treatment or interfere with the results of the study ,would preclude study participation in the judgment of the investigator; 6. Pregnant or breastfeeding women are excluded from this study; 7. Other medical condition or reason that, in the opinion of the investigator, would preclude study participation; 8. With serious concurrent complication such as active digestive tract hemorrhage, perforation, jaundice, intestinal obstruction, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety using neo-adjuvant gemcitabine plus S1 and SBRT followed by surgery for borderline resectable pancreatic cancer;Completion rate of pancreatectomy;Objective response rate (ORR);Overall survival;Progression free survival;Tumor regression grading after preoperative chemoradiotherapy;Rate of local recurrence; | — |
Countries
China
Contacts
Public ContactSheng-Ping Li
Sun Yat-sen University Cancer Center
Outcome results
None listed