Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments s-1, radiation therapy
Phase phase 2
Sponsor Japan Adjuvant Study Group of Pancreatic Cancer
Collaborator Japan Agency for Medical Research and Development
Start date September 2012
End date April 2016
Trial size 50 participants
Trial identifier NCT02459652, JASPAC 05

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
s-1
S-1 is administered orally at a dose of 40 mg/m2 twice daily on the day of irradiation (Monday through Friday) during radiation therapy.
radiation therapy
Radiation therapy is delivered with >6-megavolts (MV) photons, using a multiple field technique. A total dose of 50.4 Gy is delivered in 28 fractions over 5.5 weeks.

Primary Outcomes

Measure
R0 resection rate
time frame: Up to 4 years

Secondary Outcomes

Measure
Overall survival
time frame: up to 6 years
Disease-free survival
time frame: up to 6 years
Response rate after neoadjuvant chemoradiation
time frame: Up to 4 years
Pathological response rate
time frame: Up to 4 years
2-year survival rate
time frame: up to 6 years
Surgical morbidity rates
time frame: With in 90 days
Acute and late toxicity rates
time frame: With in 6 months
R0 resection rate in borderline resectable pancreatic cancer
time frame: Up to 4 years

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

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, /= 9.0 g/dL - leukocyte count >/= 3,000/mm3 - platelet count >/= 100,000/mm3 - serum total bilirubin /= 3.0 g/dl - serum creatinine /= 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

Additional Information

Official title Phase II Study of Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer
Principal investigator Masafumi Ikeda, M.D., Ph.D.
Description S-1: S-1 is an oral fluorinated pyrimidine agent which contains tegafur (FT, a prodrug of 5-FU), 5-chloro-2,4-dihydropyrimidine (CHDP) and potassium oxonate (Oxo) effective for gastric and various other types of cancers. S-1 is also active for pancreatic cancer: S-1 demonstrated non-inferiority to gemcitabine in overall survival for metastatic or locally advanced pancreatic cancer (LAPC). S-1 and Concurrent radiotherapy: S-1 therapy with concurrent radiation therapy (RT) had favorable activity with overall tumor response rate of 37%, as well as mild toxicity in patients with LAPC. The median survival time and the 2-year survival rate for LAPC patients treated by S-1/RT were 16.2 months and 26% respectively. Definition of Borderline Resectable Pancreatic Cancer:(1) Reconstructible bilateral impingement of superior mesenteric vein or portal vein; (2) Tumor contact with the superior mesenteric artery (SMA) of </= 180 degrees ; (3) Tumor contact with the common hepatic artery of </= 180 degrees (at the root of the gastroduodenal artery); and (4) Tumor contact with the celiac axis of </= 180 degrees. Tumor with portal vein tumor thrombus and tumor contact with the second or further jejunal SMA branch are considered as unresectable. Tumor which is contact with the common hepatic artery or celiac axis but can be resected by distal pancreatectomy with en bloc celiac axis resection, is not included in this study.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Japan Adjuvant Study Group of Pancreatic Cancer.