NCT00020345

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways, such as directly into the abdomen, and combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with radiation therapy plus surgery in treating patients who have advanced cancer of the pancreas.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 2000

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

September 1, 2000

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2007

Completed
Last Updated

October 31, 2023

Status Verified

March 1, 2012

First QC Date

March 2, 2007

Last Update Submit

October 27, 2023

Conditions

Stage IVA Pancreatic CancerStage III Pancreatic CancerAdenocarcinoma of the Pancreas

Keywords

adenocarcinoma of the pancreasadult solid tumorbody system/site cancercancercellular diagnosis, pancreatic cancergastrointestinal cancerpancreatic cancersolid tumorstage III pancreatic cancerstage IV pancreatic cancerstage IVA pancreatic cancerstage, pancreatic cancer

Interventions

fluorouracilDRUG
gemcitabineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically or cytologically confirmed adenocarcinoma of the pancreas or ampullae of vater not amenable to curative surgery Metastases confined to abdominal cavity May include peripancreatic lymph nodes, peritoneal carcinomatosis, and hepatic metastases Extrapancreatic disease must be resectable Must have progressive disease if received any prior therapy No distant metastases, including lung or bone metastases --Prior/Concurrent Therapy-- Biologic therapy: No concurrent immunotherapy for pancreatic cancer Chemotherapy: No prior gemcitabine or fluorouracil Endocrine therapy: No concurrent hormonal therapy for pancreatic cancer Radiotherapy: No prior radiotherapy for pancreatic cancer No prior abdominal or pelvic radiotherapy Surgery: See Disease Characteristics Other: At least 30 days since prior anticancer therapy and recovered --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: SGOT and SGPT less than 4 times upper limit of normal No active hepatitis Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No significant reversible ischemic changes in wall motion or perfusion with stress (correction using angiography and angioplasty allowed) No significant resting left ventricle dysfunction No unstable angina No New York Heart Association class III or IV heart disease No myocardial infarction within past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active disease increasing possibility of infection, including AIDS and other autoimmune disorders No other medical condition or psychiatric disease that would preclude study No other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix

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

Sponsors & Collaborators

Study Sites (2)

Radiation Oncology Branch

Bethesda, Maryland, 20892, United States

Location

Surgery Branch

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsNeoplasmsGastrointestinal Neoplasms

Interventions

FluorouracilGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine Nucleosides

Study Officials

  • David L. Bartlett

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

March 2, 2007

First Posted

March 6, 2007

Study Start

September 1, 2000

Study Completion

March 1, 2002

Last Updated

October 31, 2023

Record last verified: 2012-03

Locations

US(2)