Pancreatic cancer Pancreatic cancer
Conditions
Interventions
NAC-GS group
As preoperative therapy, two courses of gemcitabine plus S-1 chemotherapy will be administered.
In the GS regimen, GEM 1000 mg/m2 will be administered intravenously on Day 1 and Day 8,
however, up to two courses may be allowed depending on circumstances such as preparation time required for radiation therapy.
During the IMRT-based chemoradiotherapy in Arm B, either GEM or S-1 will b
Neoadjuvant Chemoradiotherapy
Sponsors
Hatano Etsuro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Regarding histological or cytological diagnosis of pancreatic masses, one of the following criteria must be met -Histological diagnosis confirms invasive pancreatic ductal carcinoma. In cases where the diagnosis is suspected adenocarcinoma, the imaging findings must also be consistent with pancreatic cancer. -Cytological diagnosis is Class IV or Class V, and imaging findings must also be consistent with adenocarcinoma. Refers only to adenocarcinoma or adenosquamous carcinoma among invasive pancreatic ductal carcinomas. 2) Classified as resectable pancreatic cancer based on the pancreatic cancer resectability classification. 3) The CA19-9 level is below 100 U/ml in the pre-registration examination. The CA19-9 level is referenced as measured when the serum total bilirubin level is 3.0 mg/dL or less.
Exclusion criteria
Exclusion criteria: 1) Has a history of receiving radiation therapy to the upper abdomen. 2) Has active double cancer (synchronous double cancer or metachronous double cancer with a disease-free interval of less than 3 years). *Carcinoma in situ and intramucosal carcinoma lesions are not considered active double cancer, and registration is allowed. 3) Has direct tumor invasion reaching the mucosal surface of the stomach, duodenum, or small intestine. 4) Has pulmonary fibrosis or interstitial pneumonia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year local recurrence rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Recurrence-free survival, recurrence pattern of the tumor, R0 resection rate, postoperative complication rate, Evans grade, treatment-related mortality rate, preoperative and postoperative treatment completion rate | — |
Contacts
Public ContactKei Yamane
Kyoto University
Outcome results
None listed