NCT01430052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P75+ for phase_2 pancreatic-cancer

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_2 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 21, 2017

Status Verified

April 1, 2015

Enrollment Period

3.7 years

First QC Date

September 5, 2011

Last Update Submit

November 19, 2017

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Two year survival rate

    2 years

Secondary Outcomes (4)

  • Progression free survival（PFS）

    4 years

  • Overall Survival (OS)

    4 years

  • Adverse events

    4 years

  • Response rate

    4 years

Study Arms (2)

Gemcitabine , S-1

OTHER

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, S-1, radiotherapy

EXPERIMENTAL

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

Interventions

Drug: gemcitabine, S-1DRUG

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.

Also known as: gemzer, TS-1
Gemcitabine , S-1
gemcitabine, S-1, radiotherapyDRUG

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.

Also known as: gemzer, TS-1
Gemcitabine, S-1, radiotherapy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, 537-8511, Japan

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineS 1 (combination)titanium silicideRadiotherapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTherapeutics

Study Officials

  • Tatsuya Ioka, MD

    Osaka Medical Center for Cancer and CVD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant director

Study Record Dates

First Submitted

September 5, 2011

First Posted

September 7, 2011

Study Start

April 1, 2009

Primary Completion

December 1, 2012

Study Completion

September 1, 2015

Last Updated

November 21, 2017

Record last verified: 2015-04

Locations

JP(1)