NCT00275119

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin followed by radiation therapy, fluorouracil, and oxaliplatin works in treating patients with locally advanced pancreatic cancer 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

Geographic Reach
1 country

11 active sites

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, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
Last Updated

February 9, 2009

Status Verified

January 1, 2006

First QC Date

January 10, 2006

Last Update Submit

February 6, 2009

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreasstage II pancreatic cancerstage III pancreatic cancerrecurrent pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

Secondary Outcomes (7)

  • Tolerability

  • Recurrence-free survival

  • Overall survival

  • Response rate

  • Quality of life

  • +2 more secondary outcomes

Interventions

fluorouracilDRUG
gemcitabine hydrochlorideDRUG
oxaliplatinDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the pancreas * Locally advanced, nonresectable disease * Residual disease after surgical resection (R1, R2) OR recurrent disease after radical surgery * No visceral or peritoneal metastases * No adenocarcinoma of the bile ducts or the ampulla of Vater PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Stable or controlled pain with analgesics * Not pregnant or nursing * Neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 1.5 times normal OR \< 3 mg/dL * Creatinine clearance ≥ 40 mL/min * Bilirubin ≤ 1.5 times normal * Alkaline phosphatase \< 5 times normal * No medical condition that would preclude study treatment * No active infection * Negative pregnancy test * No serious cardiac or respiratory disease * No uncontrolled or persistent hypercalcemia * No pre-existing neuropathy * No biliary or gastro-duodenal obstruction * No other malignancy except nonmelanomatous skin cancer, prostate cancer, or carcinoma in situ of the cervix or bladder * No familial, social, geographical, or psychological condition that would preclude study compliance PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior abdominal radiotherapy (encompassing the liver, pancreas, or spleen) * At least 2 months since prior radiotherapy

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

Sponsors & Collaborators

Study Sites (11)

Institut Sainte Catherine

Avignon, 84082, France

Location

Hopital Saint Andre

Bordeaux, 33075, France

Location

Clinique Tivoli

Bordeaux, F-33000, France

Location

Hopital Drevon

Dijon, 21000, France

Location

CHU de Grenoble - Hopital de la Tronche

Grenoble, F-38043, France

Location

Hopital Saint - Louis

La Rochelle, 17000, France

Location

Clinique Victor Hugo

Le Mans, F-72000, France

Location

Clinique Saint Jean

Lyon, 69008, France

Location

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13009, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

Related Publications (2)

  • Moureau-Zabotto L, Phelip JM, Afchain P, Mineur L, Andre T, Vendrely V, Lledo G, Dupuis O, Huguet F, Touboul E, Balosso J, Louvet C. Concomitant administration of weekly oxaliplatin, fluorouracil continuous infusion, and radiotherapy after 2 months of gemcitabine and oxaliplatin induction in patients with locally advanced pancreatic cancer: a Groupe Coordinateur Multidisciplinaire en Oncologie phase II study. J Clin Oncol. 2008 Mar 1;26(7):1080-5. doi: 10.1200/JCO.2007.12.8223.

    PMID: 18309942RESULT

  • Moureau-Zabotto L, Phélip J, Afchain P, et al.: Concomitant administration of weekly oxaliplatin, 5FU continuous infusion and radiotherapy in locally advanced pancreatic cancer (LAPC): a Gercor phase II study. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1077, S173-4, 2006.

    RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

FluorouracilGemcitabineOxaliplatinRadiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesCoordination ComplexesOrganic ChemicalsTherapeutics

Study Officials

  • Laurence Moureau-Zabotto, MD

    Institut Paoli-Calmettes

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 11, 2006

Study Start

November 1, 2003

Last Updated

February 9, 2009

Record last verified: 2006-01

Locations

FR(11)