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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tatsuya Ioka, Osaka Medical Center for Cancer and Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT01430052
First received: September 5, 2011
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
 Drug: Drug: gemcitabine, S-1
Drug: gemcitabine, S-1, radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study Comparing Gemcitabine/S-1 Combination Chemoradiotherapy With Gemcitabine/S-1 Combination Chemotherapy for Unresectable Locally Advanced Pancreatic Cancer.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Osaka Medical Center for Cancer and Cardiovascular Diseases:

Primary Outcome Measures:
  • Two year survival rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival（PFS） [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: April 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine , S-1
Gemcitabine 1000mg/m2 on Day 1 and 8, every 3 weeks. S-1 60-100mg/day on Day 1 to 14, every 3 weeks
 Drug: Drug: gemcitabine, S-1
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.
Other Names:
  • gemzer
  • TS-1
Experimental: Gemcitabine, S-1, radiotherapy
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
 Drug: gemcitabine, S-1, radiotherapy
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.
Other Names:
  • gemzer
  • TS-1

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430052

Locations
Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Japan, 537-8511
Sponsors and Collaborators
Osaka Medical Center for Cancer and Cardiovascular Diseases
Investigators
Study Director: Tatsuya Ioka, MD Osaka Medical Center for Cancer and CVD
  More Information

No publications provided

Responsible Party: Tatsuya Ioka, Assistant director, Osaka Medical Center for Cancer and Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT01430052     History of Changes
Other Study ID Numbers: TatsuyaIoka, UMIN000001990
Study First Received: September 5, 2011
Last Updated: February 26, 2013
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on June 17, 2013