- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00026403
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer
A Phase II Study of Gemcitabine, Cisplatin and Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have locally advanced pancreatic cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- Determine the efficacy of gemcitabine, cisplatin, and radiotherapy, in terms of 1-year survival, in patients with locally advanced pancreatic cancer.
- Determine the toxicity of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at completion of radiotherapy, at completion of chemotherapy, and 3 months after completion of therapy.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 12-28 months.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
-
-
-
-
Arizona
-
Scottsdale, Arizona, Forente stater, 85259-5404
- CCOP - Scottsdale Oncology Program
-
-
District of Columbia
-
Washington, District of Columbia, Forente stater, 20060
- MBCCOP - Howard University Cancer Center
-
-
Illinois
-
Peoria, Illinois, Forente stater, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Forente stater, 61602
- CCOP - Illinois Oncology Research Association
-
Urbana, Illinois, Forente stater, 61801
- CCOP - Carle Cancer Center
-
-
Iowa
-
Cedar Rapids, Iowa, Forente stater, 52403-1206
- CCOP - Cedar Rapids Oncology Project
-
Des Moines, Iowa, Forente stater, 50309-1016
- CCOP - Iowa Oncology Research Association
-
Sioux City, Iowa, Forente stater, 51101-1733
- Siouxland Hematology-Oncology
-
-
Kansas
-
Wichita, Kansas, Forente stater, 67214-3882
- CCOP - Wichita
-
-
Louisiana
-
New Orleans, Louisiana, Forente stater, 70121
- CCOP - Ochsner
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48106
- CCOP - Michigan Cancer Research Consortium
-
-
Minnesota
-
Duluth, Minnesota, Forente stater, 55805
- CCOP - Duluth
-
Rochester, Minnesota, Forente stater, 55905-0001
- Mayo Clinic Cancer Center
-
Saint Cloud, Minnesota, Forente stater, 56303
- CentraCare Health Plaza
-
Saint Louis Park, Minnesota, Forente stater, 55416
- CCOP - Metro-Minnesota
-
-
Nebraska
-
Omaha, Nebraska, Forente stater, 68106
- CCOP - Missouri Valley Cancer Consortium
-
-
North Dakota
-
Bismarck, North Dakota, Forente stater, 58501-5505
- Medcenter One Health System
-
Fargo, North Dakota, Forente stater, 58122
- CCOP - Merit Care Hospital
-
Grand Forks, North Dakota, Forente stater, 58201
- Altru Cancer Center
-
-
Ohio
-
Toledo, Ohio, Forente stater, 43623-3456
- CCOP - Toledo Community Hospital
-
-
Pennsylvania
-
Danville, Pennsylvania, Forente stater, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
-
Pittsburgh, Pennsylvania, Forente stater, 15212-4772
- Allegheny General Hospital
-
-
South Dakota
-
Rapid City, South Dakota, Forente stater, 57709
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Forente stater, 57104
- CCOP - Sioux Community Cancer Consortium
-
-
Wisconsin
-
Green Bay, Wisconsin, Forente stater, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically confirmed unresectable adenocarcinoma of the pancreas
- No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin
Prior subtotal resection or gross residual disease
- No microscopic residual disease only
- No metastatic disease outside of planned study radiotherapy field
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST no greater than 3 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to maintain adequate oral nutrition
- No significant infection
- No other medical condition that would preclude study
- No other malignancy within the past 5 years except non-melanoma skin cancer
- No significant nausea or vomiting
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior or concurrent biologic therapy
Chemotherapy:
- No prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy that would overlap planned study radiotherapy fields
Surgery:
- See Disease Characteristics
- At least 21 days since prior laparotomy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: radiotherapy + gemcitabine + cisplatin
Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at completion of radiotherapy, at completion of chemotherapy, and 3 months after completion of therapy. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
total overlevelse
Tidsramme: 12 måneder
|
12 måneder
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
quality of life
Tidsramme: Up to 3 years
|
Up to 3 years
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Haddock MG, Swaminathan R, Foster NR, Hauge MD, Martenson JA, Camoriano JK, Stella PJ, Tenglin RC, Schaefer PL, Moore DF Jr, Alberts SR. Gemcitabine, cisplatin, and radiotherapy for patients with locally advanced pancreatic adenocarcinoma: results of the North Central Cancer Treatment Group Phase II Study N9942. J Clin Oncol. 2007 Jun 20;25(18):2567-72. doi: 10.1200/JCO.2006.10.2111.
- Haddock MG, Swaminathan R, Alberts SR, et al.: Gemcitabine (Gem), cisplatin (Cis) and radiation therapy (RT) for patients with locally advanced pancreatic adenocarcinoma (ACA): a North Central Cancer Treatment Group (NCCTG) phase II study. [Abstract] J Clin Oncol 22 (Suppl 14): A-4121, 343s, 2004.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
- Cisplatin
Andre studie-ID-numre
- NCCTG-N9942
- NCI-2012-02426 (Registeridentifikator: CTRP (Clinical Trials Reporting System))
- CDR0000069026 (Registeridentifikator: PDQ (Physician Data Query))
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Bukspyttkjertelkreft
-
Tianjin Medical University Cancer Institute and...Har ikke rekruttert ennåPDAC - Pancreatic Ductal Adenocarcinoma
-
Sun Yat-sen UniversityRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaKina
-
Azienda Ospedaliera Universitaria Integrata VeronaRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaItalia
-
Azienda Ospedaliera Universitaria Integrata VeronaRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaItalia
-
Cedars-Sinai Medical CenterRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaForente stater
-
Radboud University Medical CenterDutch Cancer SocietyRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaNederland
-
Thomas Jefferson UniversityUkjentBukspyttkjertelfistel | Distal pankreatektomikomplikasjoner | Falciform Patch Pancreatic Closure | Fibrinlim bukspyttkjertellukkingForente stater
-
Imperial College LondonThe Leeds Teaching Hospitals NHS Trust; Sheffield Teaching Hospitals NHS... og andre samarbeidspartnereRekrutteringBukspyttkjertelkreft | PDAC - Pancreatic Ductal AdenocarcinomaStorbritannia
-
Chinese PLA General HospitalRekrutteringNeoplasmer i bukspyttkjertelen | Bukspyttkjertelkreft | Bukspyttkjertelkreft | PDAC - Pancreatic Ductal AdenocarcinomaKina
-
Andrei IagaruIkke lenger tilgjengeligKarsinoide svulster | Islet Cell (Pancreatic NET) | Andre nevroendokrine svulsterForente stater
Kliniske studier på strålebehandling
-
Alpha Tau Medical LTD.RekrutteringLungekreft | Tilbakevendende lungekreftIsrael
-
Alpha Tau Medical LTD.RekrutteringHudkreft | Slimhinneneoplasma i munnhulen | MykvevsneoplasmaIsrael
-
Alpha Tau Medical LTD.RekrutteringProstata adenokarsinomIsrael
-
Alpha Tau Medical LTD.RekrutteringHudkreft | Slimhinneneoplasma i munnhulen | MykvevsneoplasmaIsrael
-
Alpha Tau Medical LTD.AvsluttetMetastatisk brystkreft | Brystkarsinom | Invasiv brystkreft | Fjernmetastaser. PatologiDen russiske føderasjonen
-
Alpha Tau Medical LTD.FullførtPlateepitelkarsinom i hudenItalia
-
Alpha Tau Medical LTD.European Organisation for Research and Treatment of Cancer - EORTCHar ikke rekruttert ennåPlateepitelkarsinom i hode og nakke | PlateepitelkarsinomIsrael
-
Alpha Tau Medical LTD.RekrutteringHudkreft | Slimhinneneoplasma i munnhulen | MykvevsneoplasmaItalia
-
Alpha Tau Medical LTD.Aktiv, ikke rekrutterendeHudkreft | Slimhinneneoplasma i munnhulen | MykvevsneoplasmaIsrael
-
Alpha Tau Medical LTD.RekrutteringHudkreft | Slimhinneneoplasma i munnhulen | MykvevsneoplasmaIsrael