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Neoadjuvant radiation therapy concurrent with S-1 followed by systemic Gemcitabine therapy for Borderline resectable pancreatic cancer patients; A phase2 study

Neoadjuvant radiation therapy concurrent with S-1 followed by systemic Gemcitabine therapy for Borderline resectable pancreatic cancer patients; A phase2 study - A phase2 study of neoadjuvant S1+RT followed by systemic Gem therapy for Borderline resectable pancreatic cancer patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012293
Enrollment
45
Registered
2013-11-15
Start date
2013-11-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer

Interventions

Concurrent radiotherapy with S-1: S-1 (80mg/m2) on the irradiated day, Radiotherapy
a total dose of 50.4 Gy in 28 fractions. Systemic Gemcitabine therapy: Gemcitabine (1000mg/m2) is given by intravenous infusion over 30 min on days 1, 8, 15 every 4 week. This cycle was repeated 3 cy

Sponsors

Hokkaido Pancreatic Cancer Study Group (HOPS)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Pathologically or cytologically proven diagnosis of pancreas cancer. 2) Definition of a Borderline resectable pancreatic cancer is filled in NCCN guidelines 2012 pancreatic adenocarcinoma 3) No hepatic metastasis by EOB-MR 4) Patients of age =>20 and 75> 5) Performance Status:0-1 (ECOG) 6) Adequate oral intake 7) Good main organ function 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) treatment history of a pancreatic cancer (chemotherapy, radiotherapy, surgical) 2) treatment history of other malignant tumors (chemotherapy, radiotherapy) 3) Patients who can' t receive neither iodic drug because of drug allergy 4) Including in an exposure field is impossible with contrast enhanced CT 5) Massive pleural or abdominal effusion 6) Pleural membranes and peritoneum sowing are proved by cytological diagnosis 7) Existence of tumor exposure with CT or Endoscope 8) Hemorrhagic peptic ulcer 9) Watery diarrhea 10) Regular use of frucitocin, fenitoin or warfarin 11) Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings 12) Severe infection 13) Serious complications (e.g. heart failure, hepatic failure, intestinal paralysis, intestinal obstruction) 14) Uncontrolled diabetes 15) Simultaneous or metachronous (within 3 years) double cancers 16) Patients requiring systemic steroids medication 17) Severe mental illness 18) Severe drug hypersensitivity 19) Males that are currently attempting to produce a pregnancy 20) Pregnant females, possibly pregnant females, females wishing to become pregnant 21) Patients seems inadequate for this study by investigators

Design outcomes

Primary

MeasureTime frame
R0 resection rate

Secondary

MeasureTime frame
completion rate, pathological effect , Response rate, CA19-9 response rate, progression free survival, distant metastasis free survival, overall survival, adverse effect, surgical complication

Countries

Japan

Contacts

Public ContactTsuyoshi Hayashi

Sapporo Medical University Department of Medical Oncology and Hematology

thayashi69@sapmed.ac.jp011-611-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026