- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00275119
Gemcitabine and Oxaliplatin Followed By Radiation Therapy, Fluorouracil, and Oxaliplatin in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
Protocole de Phase II: Etude de Faisabilite de L'Oxaliplatine en Association Chimio-Radiotherapie Concomitante Dans le Traitement Des Cancers du Pancreas Localement Avances Non Resecables
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
Primary
- Compare progression-free survival of patients with locally advanced, nonresectable adenocarcinoma of the pancreas treated with gemcitabine hydrochloride and oxaliplatin followed by concurrent radiotherapy, fluorouracil, and oxaliplatin.
Secondary
- Determine the tolerability of this regimen, in both the short- and long-term, in these patients.
- Determine recurrence-free survival, overall survival, and response rate in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the clinical benefits of this regimen in these patients.
- Determine locoregional and metastatic progression-free survival of patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
- Chemotherapy: Patients receive gemcitabine hydrochloride over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are restaged at day 15-21 of the fourth course of chemotherapy. Patients with nonmetastatic disease proceed to chemoradiotherapy.
- Chemoradiotherapy: Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive fluorouracil IV continuously in weeks 1-5 and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29 in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at restaging, and at day 28 after completion of chemoradiotherapy.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
Studietype
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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-
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Avignon, Frankrike, 84082
- Institut Sainte Catherine
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Bordeaux, Frankrike, 33075
- Hopital Saint André
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Bordeaux, Frankrike, F-33000
- Clinique Tivoli
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Dijon, Frankrike, 21000
- Hopital Drevon
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Grenoble, Frankrike, F-38043
- CHU de Grenoble - Hopital de la Tronche
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La Rochelle, Frankrike, 17000
- Hopital Saint - Louis
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Le Mans, Frankrike, F-72000
- Clinique Victor Hugo
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Lyon, Frankrike, 69008
- Clinique Saint Jean
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Marseille, Frankrike, 13009
- Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
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Paris, Frankrike, 75970
- Hôpital Tenon
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Paris, Frankrike, 75571
- Hopital Saint Antoine
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
---|
Progresjonsfri overlevelse
|
Sekundære resultatmål
Resultatmål |
---|
Svarprosent
|
Total overlevelse
|
Livskvalitet
|
Tolerabilitet
|
Gjentaksfri overlevelse
|
Kliniske fordeler
|
Locoregional and metastatic progression-free survival
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Laurence Moureau-Zabotto, MD, Institut Paoli-Calmettes
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer
- Neoplasmer etter nettsted
- Sykdommer i det endokrine systemet
- Neoplasmer i fordøyelsessystemet
- Neoplasmer i endokrine kjertel
- Pankreassykdommer
- Neoplasmer i bukspyttkjertelen
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Gemcitabin
- Fluorouracil
- Oksaliplatin
Andre studie-ID-numre
- CDR0000454568
- GERCOR-D03-1
- EU-20570
- SANOFI-GERCOR-D03-1
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