Clinical trial · Interventional
Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer
Phase II Study of Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer
NCT02459652CI-TRIAL-00047943completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multicenter Prospective Phase II Study for Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer RATIONALE: Borderline resectable pancreatic cancer is frequently related to a positive surgical margin and has a poor prognosis after resection. Neoadjuvant chemoradiation with intensive local effect may lead to substantial local control and prolongation of survival in borderline resectable pancreatic cancer. PURPOSE: This phase II trial assess efficacy and safety of neoadjuvant S-1 and concurrent radiotherapy for borderline resectable pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Radiation | — | UNRESOLVED |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant S-1/RT
- description
- This is a single arm prospective study. All eligible subjects will receive neoadjuvant S-1 and concurrent radiation followed by surgical resection. Subjects may receive adjuvant chemotherapy after surgical resection at the clinical discretion of the medical oncologists.
- interventionNames
- Drug: S-1
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- R0 resection rate
- timeFrame
- Up to 4 years
- description
- R0 resection rate of all patients enrolled in the study
Secondary outcomes (8)
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Cytologic or histologic proof of pancreatic ductal carcinoma or adenosquamous carcinoma is required prior to study entry. * Disease assessment by Multi Detector-row Computed Tomography (MDCT) scan within 2 weeks of study entry * Borderline resectable pancreatic cancer * No evidence of metastatic disease as determined by chest CT scan, and abdominal CT scan and laparoscopy. Paraaortic lymph node metastasis is considered as metastatic. * Age \>/=20 years old, \</=75 years old * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * No prior chemotherapy or radiotherapy for pancreatic cancer * A square 10 x 10 cm radiation field could encompass all pancreatic lesions and lymph node metastases * Adequate oral intake * Appropriate biliary drainage for obstructive jaundice * Lab Values: * hemoglobin concentration \>/= 9.0 g/dL * leukocyte count \>/= 3,000/mm3 * platelet count \>/= 100,000/mm3 * serum total bilirubin \</= 2.0 mg dL, or \</=3.0 mg/dL with biliary drainage * Aspartate Transaminase (AST) and Alanine Transaminase (ALT) \</= 100 U/L, or \</= 150 U/L with biliary drainage * serum albumin \>/= 3.0 g/dl * serum creatinine \</= 1.2 mg dL * Creatinine clearance \>/= 50 ml/min * Written informed consent Exclusion Criteria: * Tumor invasion to the alimentary tract determined by abdominal CT scan or endoscopic examination * Prior chemotherapy using fluoropyrimidine * Prior radiation therapy to the abdomen * Watery diarrhea * Concurrent phenytoin, warfarin potassium, or flucytosine treatment * Presence of contrast medium allergy * Pulmonary fibrosis or interstitial pneumonia * Pleural effusion or ascites * Active infection * Uncontrolled diabetes mellitus (FBS \>/= 200mg/dL or HbA1c \>/= 10.0) * Active concomitant malignancy * Active gastroduodenal ulcer * Severe complications such as cardiac or renal disease * Regular administration of systemic corticosteroid * Psychiatric disorder * History of drug hypersensitivity * Pregnant and lactating women and women of childbearing age who were not using effective contraception
References
Publications (2)
- BACKGROUNDTakahashi S, Ohno I, Ikeda M, Kobayashi T, Akimoto T, Kojima M, Konishi M, Uesaka K. Neoadjuvant S-1 with concurrent radiotherapy followed by surgery for borderline resectable pancreatic cancer: study protocol for an open-label, multicentre, prospective phase II trial (JASPAC05). BMJ Open. 2017 Oct 22;7(10):e018445. doi: 10.1136/bmjopen-2017-018445. PMID 29061632
- BACKGROUNDTakahashi S, Ohno I, Ikeda M, Konishi M, Kobayashi T, Akimoto T, Kojima M, Morinaga S, Toyama H, Shimizu Y, Miyamoto A, Tomikawa M, Takakura N, Takayama W, Hirano S, Otsubo T, Nagino M, Kimura W, Sugimachi K, Uesaka K. Neoadjuvant S-1 With Concurrent Radiotherapy Followed by Surgery for Borderline Resectable Pancreatic Cancer: A Phase II Open-label Multicenter Prospective Trial (JASPAC05). Ann Surg. 2022 Nov 1;276(5):e510-e517. doi: 10.1097/SLA.0000000000004535. Epub 2020 Oct 15. PMID 33065644