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

NCT02459652 | Completed Phase 2

• 1 other identifier: JASPAC 05
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

Pancreatic Cancer

Keywords

Borderline Resectable Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  R0 resection rate of all patients enrolled in the study

  Up to 4 years

Secondary Outcomes (8)

• Overall survival

  up to 6 years

• Disease-free survival

  up to 6 years

• Response rate after neoadjuvant chemoradiation

  Up to 4 years

• Pathological response rate

  Up to 4 years

• 2-year survival rate

  up to 6 years

Study Arms (1)

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.

Drug: S-1; Radiation: Radiation Therapy

Interventions

S-1 DRUG

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.

Neoadjuvant S-1/RT

Radiation Therapy RADIATION

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

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Japan Adjuvant Study Group of Pancreatic Cancer: lead
• Japan Agency for Medical Research and Development: collaborator
• Pharma Valley Center: collaborator

Study Sites (22)

Aichi Cancer Center

Nagoya, Aichi-ken, 464-8681, Japan

Location

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

Hirosaki University Hospital

Hirosaki, Aomori, 036-8563, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

Location

Fukuyama City Hospital

Fukuyama, Hiroshima, 721-8511, Japan

Location

National Hospital Organization Kure Medical Center

Kure, Hiroshima, 737-0023, Japan

Location

Asahikawa Medical University

Asahikawa, Hokkaido, 078-8510, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, 216-8511, Japan

Location

Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan

Location

National Hospital Organization Osaka National Hospital

Chuo-ku, Osaka, 540-0006, Japan

Location

Saitama Cancer Center

Kita-adachigun Inamachi, Saitama, 362-0806, Japan

Location

Seirei Mikatahara General Hospital

Hamamatsu, Shizuoka, 433-8558, Japan

Location

Shizuoka Cancer Center

Suntohgun, Nagaizumityo, Shizuoka, 411-8777, Japan

Location

Jichi Medical University Hospital

Shimotsuke, Tochigi, 329-0498, Japan

Location

Tochigi Cancer Center

Utsunomiya, Tochigi, 320-0834, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku, Tokyo, 162-8666, Japan

Location

Chiba Cancer Center

Chiba, 260-8717, Japan

Location

National Hospital Organization Kyusyu Cancer Center

Fukuoka, 811-1395, Japan

Location

Yamagata University Hospital

Yamagata, 990-9585, Japan

Location

Related Publications (2)

• Takahashi 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 BACKGROUND

• Takahashi 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 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

S 1 (combination); Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Masafumi Ikeda, M.D., Ph.D.

  National Cancer Center Hospital East, Department of Hepatobiliary Pancreatic Oncology

  PRINCIPAL INVESTIGATOR

• Katsuhiko Uesaka, M.D., Ph.D.

  Shizuoka Cancer Center Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 2, 2015
• Study Start: December 28, 2012
• Primary Completion: May 13, 2016
• Study Completion: July 17, 2018
• Last Updated: October 27, 2020

Record last verified: 2020-10

Locations

JP (22)