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Pancreatic CancerPhase 2NCT02459652

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

A Phase 2 study testing S-1 and Radiation Therapy in people with Pancreatic Cancer, run by Japan Adjuvant Study Group of Pancreatic Cancer at 22 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
S-1 and Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
22 sitesJapan
Study dates
28 Dec 2012to 17 Jul 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Japan22 sites

  • Asahikawa Medical University

    Asahikawa, Hokkaido, 078-8510

  • Chiba Cancer Center

    Chiba, 260-8717

  • National Hospital Organization Osaka National Hospital

    Chuo-ku, Osaka, 540-0006

  • National Hospital Organization Kyusyu Cancer Center

    Fukuoka, 811-1395

  • Fukuyama City Hospital

    Fukuyama, Hiroshima, 721-8511

  • Seirei Mikatahara General Hospital

    Hamamatsu, Shizuoka, 433-8558

  • Hirosaki University Hospital

    Hirosaki, Aomori, 036-8563

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • St. Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa, 216-8511

  • Saitama Cancer Center

    Kita-adachigun Inamachi, Saitama, 362-0806

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • National Hospital Organization Kure Medical Center

    Kure, Hiroshima, 737-0023

  • Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 329-0498

  • Tokyo Women's Medical University Hospital

    Shinjuku, Tokyo, 162-8666

  • Shizuoka Cancer Center

    Suntohgun, Nagaizumityo, Shizuoka, 411-8777

  • Tochigi Cancer Center

    Utsunomiya, Tochigi, 320-0834

  • Yamagata University Hospital

    Yamagata, 990-9585

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

About this study

Official title: Phase II Study of Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer

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.

Read the detailed 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.

Being tested
S-1, Radiation Therapy
Keywords
Borderline Resectable Pancreatic Cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S-1Drug

    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 TherapyRadiation

    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.

Study groups in NCT02459652
Study groupRoleWhat they receive
Neoadjuvant S-1/RTExperimentalThis 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.
Receives: Drug: S-1; Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. R0 resection rate

    R0 resection rate of all patients enrolled in the study

    Measured: Up to 4 years

Secondary outcomes (8)

  1. Overall survival

    Measured: up to 6 years

  2. Disease-free survival

    Measured: up to 6 years

  3. Response rate after neoadjuvant chemoradiation

    All responses will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 within 4 weeks after completion of neoadjuvant therapy.

    Measured: Up to 4 years

  4. Pathological response rate

    Evaluation of the pathological response of the primary tumor was performed using a classification by Evans et al.

    Measured: Up to 4 years

  5. 2-year survival rate

    Measured: up to 6 years

  6. Surgical morbidity rates

    Both Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and Clavien-Dindo Classification will be used for all morbidity assessments.

    Measured: With in 90 days

  7. Acute and late toxicity rates

    All toxicities will be measured by CTCAE version 4.0.

    Measured: With in 6 months

  8. R0 resection rate in borderline resectable pancreatic cancer

    Diagnosis of borderline resectable pancreatic cancer will be fixed by Diagnostic Radiology Central Review.

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2015 (estimated)
  2. Study start28 Dec 2012
  3. Primary completion13 May 2016
  4. Study completion17 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02459652
Sponsor's protocol ID
JASPAC 05
Status last verified
Oct 2020
First submitted
29 May 2015
Last updated
27 Oct 2020
Results posted
No

Publications

  • 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.

    PubMed 29061632

  • 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.

    PubMed 33065644

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing S-1 and Radiation Therapy in people with Pancreatic Cancer, run by Japan Adjuvant Study Group of Pancreatic Cancer at 22 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 resection rate (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02459652, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020; AzTrials last refreshed its copy on 26 Oct 2026.

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