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
  • Phase

    Phase 2
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

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.
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
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.
Study Started
Dec 28
Primary Completion
May 13
Study Completion
Jul 17
Last Update
Oct 27

Drug 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 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.

Neoadjuvant S-1/RT 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.


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
No Results Posted