NCT00436267

Brief Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy in different ways and giving it together with chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving internal radiation therapy and external radiation therapy together with fluorouracil works in treating patients with newly diagnosed or recurrent pancreatic cancer and liver metastases that cannot be removed by surgery.

Trial Health

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Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Last Updated

December 19, 2013

Status Verified

November 1, 2009

Enrollment Period

2.9 years

First QC Date

February 15, 2007

Last Update Submit

December 18, 2013

Conditions

Metastatic CancerPancreatic Cancer

Keywords

recurrent pancreatic cancerstage IV pancreatic cancerliver metastases

Outcome Measures

Primary Outcomes (2)

  • Tumor response

  • Hepatic and systemic toxicity

Secondary Outcomes (2)

  • Time to progression

  • Survival

Interventions

fluorouracilDRUG
selective external radiation therapyRADIATION
tomotherapyRADIATION
yttrium Y 90 glass microspheresRADIATION
yttrium Y 90 resin microspheresRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed pancreatic cancer with liver metastases * Unresectable disease AND meets any of the following criteria: * Newly diagnosed disease * No prior treatment * Received prior treatment and progressed * Underwent prior pancreatectomy and progressed * Liver-only disease (receives selective internal radiotherapy only) * No known CNS metastases * No known diffuse peritoneal metastases PATIENT CHARACTERISTICS: * Karnofsky performance status 80-100% * Life expectancy \> 3 months * WBC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * Bilirubin \< 2 mg/dL (without extrahepatic biliary obstruction) * Albumin \> 2 g/dL * Creatinine \< 2 mg/dL * Not pregnant PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior surgery, chemotherapy, and biologic therapy allowed * No prior external beam radiotherapy to liver or pancreatic bed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Center for Cancer Care at Goshen General Hospital

Goshen, Indiana, 46526, United States

Location

MeSH Terms

Conditions

Neoplasm MetastasisPancreatic Neoplasms

Interventions

FluorouracilSerotonin Plasma Membrane Transport ProteinsRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSymportersIon PumpsMembrane Transport ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsPlasma Membrane Neurotransmitter Transport ProteinsNeurotransmitter Transport ProteinsSolute Carrier ProteinsMembrane ProteinsRadiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Kenneth L. Pennington, MD

    Goshen Health System

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2007

First Posted

February 19, 2007

Study Start

November 1, 2006

Primary Completion

October 1, 2009

Last Updated

December 19, 2013

Record last verified: 2009-11

Locations

US(1)