Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer

• Status: Completed
• Trial end date: 2018-07-17
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Adjuvant Study Group of Pancreatic Cancer
• Collaborators: Japan Agency for Medical Research and Development; Pharma Valley Center

Criteria

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,
• 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
• Aspartate Transaminase (AST) and Alanine Transaminase (ALT)150 U/L with biliary drainage

• serum albumin >/= 3.0 g/dl

• serum creatinine
• 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