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Chemoradiotherapy With Gemcitabine/S-1 vs Gemcitabine/S-1 for Locally Advanced Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Drug: gemcitabine, S-1
gemcitabine, S-1, radiotherapy
Sponsored by
Osaka Medical Center for Cancer and Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer.

  2. Patients who confirmed unresectable locally advanced pancreatic cancer with the criteria below.

    • Involving over 1/2 circumference of major artery (SMA/CA). (Under 1/2 that was borderline lesion.)
    • Involving over the merging section of portal-SMV.
    • No distal metastasis with diagnostic imaging.
    • Confirmed by CT image performed with in four weeks before registration.
  3. Performance Status:0-1(ECOG)
  4. Patients of age =>20 and 80>

  5. sufficient organ functions

    • neutrophils>=1,500/mm3
    • platelets>=100,000/mm3
    • hemoglobin>=9.0g/dl
    • AST(GOT)/ALT(GPT) <=150IU
    • total bilirubin <=2.0mg/dl, (or <=3.0mg/dl if biliary drainage were present)
    • serum creatinine <= 1.2mg/dl
    • creatinine clearance>=60ml/min
  6. Life expectancy more than 3 months.
  7. Written informed consent.

Exclusion Criteria:

  1. Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings.
  2. Watery diarrhea
  3. Severe infection
  4. Severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc)
  5. Massive pleural or abdominal effusion.
  6. Metastasis to central nervous system.
  7. Active synchronous or metachronous malignancy other than carcinoma in situ.
  8. Regular use of flucytosine, fenitoin or warfarin
  9. Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
  10. Severe mental illness
  11. Patients who are judged inappropriate for the entry into the study by the investigator.

Sites / Locations

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Gemcitabine , S-1

Gemcitabine, S-1, radiotherapy

Arm Description

Gemcitabine 1000mg/m2 on Day 1 and 8, every 3 weeks. S-1 60-100mg/day on Day 1 to 14, every 3 weeks

Gemcitabine 600mg/m2 on Day 1 and 8, every 3 weeks. S-1 60-100mg/day on Day 1 to 14, every 3 weeks with radiotherapy 50.4Gy in 28 fractions

Outcomes

Primary Outcome Measures

Two year survival rate

Secondary Outcome Measures

Progression free survival（PFS）
Overall Survival (OS)
Adverse events
Response rate

Full Information

First Posted
September 5, 2011
Last Updated
November 19, 2017
Sponsor
Osaka Medical Center for Cancer and Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT01430052
Brief Title
Chemoradiotherapy With Gemcitabine/S-1 vs Gemcitabine/S-1 for Locally Advanced Pancreatic Cancer
Official Title
Randomized Phase II Study Comparing Gemcitabine/S-1 Combination Chemoradiotherapy With Gemcitabine/S-1 Combination Chemotherapy for Unresectable Locally Advanced Pancreatic Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Osaka Medical Center for Cancer and Cardiovascular Diseases

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the clinical effectiveness of Gemcitabine/S-1 combination chemoradiotherapy with Gemcitabine /S-1 combination chemotherapy for unresectable locally advanced pancreatic cancer.
Detailed Description
When cancer develops outside of the pancreas from within the anatomical placement of the pancreas itself, it becomes difficult to excise in most cases. Generally, most pancreatic cancers are already unresectable at the time of diagnosis when we have recognized infiltration of over 1/2 the circumference of major arteries such as the celiac artery and super mesenteric artery in particular. In comparison with advanced pancreatic cancer with distant metastases, it is not easy to treat unresectable locally advanced pancreatic cancer, even when performing standard gemcitabine monotherapy. In the case of unresectable locally advanced pancreatic cancers without distant metastases, we are left with the choice of whether or not to perform radiation therapy. This decision remains unsolved worldwide, despite the continuing efforts of researchers to bring an end to the clinical doubt. We will report our results as well as the problems of combining treatments with chemoradiotherapy, using the novel anticancer agent gemcitabine as well as/or S-1, not 5FU, predominantly from our own clinical trials on this occasion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine , S-1
Arm Type
Other
Arm Description
Gemcitabine 1000mg/m2 on Day 1 and 8, every 3 weeks. S-1 60-100mg/day on Day 1 to 14, every 3 weeks
Arm Title
Gemcitabine, S-1, radiotherapy
Arm Type
Experimental
Arm Description
Gemcitabine 600mg/m2 on Day 1 and 8, every 3 weeks. S-1 60-100mg/day on Day 1 to 14, every 3 weeks with radiotherapy 50.4Gy in 28 fractions
Intervention Type
Drug
Intervention Name(s)
Drug: gemcitabine, S-1
Other Intervention Name(s)
gemzer, TS-1
Intervention Description
Gemcitabine 1,000mg/㎡ is administered with 30 min intravenous infusion on day 1 and 8 every 3 weeks. S-1 60mg/㎡/day is administered orally for 2 consecutive weeks every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
gemcitabine, S-1, radiotherapy
Other Intervention Name(s)
gemzer, TS-1
Intervention Description
Gemcitabine 600mg/㎡ is administered with 30 min intravenous infusion on day 1 and 8 every 3 weeks. S-1 60mg/㎡/day is administered orally for 2 consecutive weeks every 3 weeks. Concurrent radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions.
Primary Outcome Measure Information:
Title
Two year survival rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression free survival（PFS）
Time Frame
4 years
Title
Overall Survival (OS)
Time Frame
4 years
Title
Adverse events
Time Frame
4 years
Title
Response rate
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer. Patients who confirmed unresectable locally advanced pancreatic cancer with the criteria below. Involving over 1/2 circumference of major artery (SMA/CA). (Under 1/2 that was borderline lesion.) Involving over the merging section of portal-SMV. No distal metastasis with diagnostic imaging. Confirmed by CT image performed with in four weeks before registration. Performance Status:0-1(ECOG) Patients of age =>20 and 80> sufficient organ functions neutrophils>=1,500/mm3 platelets>=100,000/mm3 hemoglobin>=9.0g/dl AST(GOT)/ALT(GPT) <=150IU total bilirubin <=2.0mg/dl, (or <=3.0mg/dl if biliary drainage were present) serum creatinine <= 1.2mg/dl creatinine clearance>=60ml/min Life expectancy more than 3 months. Written informed consent. Exclusion Criteria: Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings. Watery diarrhea Severe infection Severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc) Massive pleural or abdominal effusion. Metastasis to central nervous system. Active synchronous or metachronous malignancy other than carcinoma in situ. Regular use of flucytosine, fenitoin or warfarin Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy Severe mental illness Patients who are judged inappropriate for the entry into the study by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatsuya Ioka, MD
Organizational Affiliation
Osaka Medical Center for Cancer and CVD
Official's Role
Study Director
Facility Information:
Facility Name
Osaka Medical Center for Cancer and Cardiovascular Diseases
City
Osaka
ZIP/Postal Code
537-8511
Country
Japan

12. IPD Sharing Statement

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Chemoradiotherapy With Gemcitabine/S-1 vs Gemcitabine/S-1 for Locally Advanced Pancreatic Cancer

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