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Trial record 52 of 3209 for:    Pancreatic Cancer AND pancreas

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02459652
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : October 27, 2020
Sponsor:
Collaborators:
Japan Agency for Medical Research and Development
Pharma Valley Center
Information provided by (Responsible Party):
Japan Adjuvant Study Group of Pancreatic Cancer

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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: S-1 Radiation: Radiation Therapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer
Actual Study Start Date : December 28, 2012
Actual Primary Completion Date : May 13, 2016
Actual Study Completion Date : July 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neoadjuvant S-1/RT
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
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.




Primary Outcome Measures :
  1. R0 resection rate [ Time Frame: Up to 4 years ]
    R0 resection rate of all patients enrolled in the study


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: up to 6 years ]
  2. Disease-free survival [ Time Frame: up to 6 years ]
  3. Response rate after neoadjuvant chemoradiation [ Time Frame: Up to 4 years ]
    All responses will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 within 4 weeks after completion of neoadjuvant therapy.

  4. Pathological response rate [ Time Frame: Up to 4 years ]
    Evaluation of the pathological response of the primary tumor was performed using a classification by Evans et al.

  5. 2-year survival rate [ Time Frame: up to 6 years ]
  6. Surgical morbidity rates [ Time Frame: With in 90 days ]
    Both Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and Clavien-Dindo Classification will be used for all morbidity assessments.

  7. Acute and late toxicity rates [ Time Frame: With in 6 months ]
    All toxicities will be measured by CTCAE version 4.0.

  8. R0 resection rate in borderline resectable pancreatic cancer [ Time Frame: Up to 4 years ]
    Diagnosis of borderline resectable pancreatic cancer will be fixed by Diagnostic Radiology Central Review.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, </=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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459652


Locations
Show Show 22 study locations
Sponsors and Collaborators
Japan Adjuvant Study Group of Pancreatic Cancer
Japan Agency for Medical Research and Development
Pharma Valley Center
Investigators
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Principal Investigator: Masafumi Ikeda, M.D., Ph.D. National Cancer Center Hospital East, Department of Hepatobiliary Pancreatic Oncology
Study Chair: Katsuhiko Uesaka, M.D., Ph.D. Shizuoka Cancer Center Hospital
Publications:
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Responsible Party: Japan Adjuvant Study Group of Pancreatic Cancer
ClinicalTrials.gov Identifier: NCT02459652    
Other Study ID Numbers: JASPAC 05
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Keywords provided by Japan Adjuvant Study Group of Pancreatic Cancer:
Borderline Resectable Pancreatic Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases