- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01045941
Safety Study of Adjuvant Gemcitabine Started One Week After Laparoscopic Distal Pancreatectomy for Adenocarcinoma
Phase II Study of Adjuvant Gemcitabine Started One Week After Laparoscopic
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Gemcitabine-based chemo¬therapy remains the cornerstone for treatment of locally advanced or metastatic pancreatic cancer. Other novel chemotherapeutic combinations have been investigated in clinical trials, but the overall conclusions are that these agents have failed to improve outcomes. Our hypothesis is that nodal and hematologic micrometastasis make pancreas cancer a systemic problem at the time of surgery. Waiting the traditional six weeks to begin adjuvant therapy allows this very aggressive cancer to metastasize while the patient is waiting to begin therapy. This leads to the increased incidence of locoregional recurrence and poor prognosis. We believe that laparoscopic distal pancreatectomy for cancer allows quicker recovery and significantly reduces the chances of postoperative wound breakdown. This will shorten the wait time required to begin adjuvant therapy to one week after surgery thereby combating the micrometastasis unseen at the time of surgery. Prognosis for patients with pancreatic cancer will therefore improve along with decreasing the incidence of locoregional recurrence.
Methods: We will perform a prospective, non-randomized phase II study with patients undergoing laparoscopic distal pancreatectomy for pancreatic adenocarcinoma at Johns Hopkins Hospital. Gemcitabine will be given as a single-agent chemotherapy regimen one week following laparoscopic distal pancreatectomy according to the protocol designed by our medical oncologist. Six cycles of gemcitabine will be given. The patients will be followed in the medical oncology clinic weekly. Our Primary outcome variable will be all cause postoperative morbidity. Our sample size will be small (6-10 patients) as this is a Phase II study. Early termination rules include development of prohibitive toxicity or death. Our endpoints are an improvement in overall survival, quality of life, progression free survival, or disease free survival. Exclusion criteria will include patients with T4 or M1 disease, R2 resection margin, preoperative therapy, or if adjuvant therapy status was unknown.
Undersøgelsestype
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Maryland
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Baltimore, Maryland, Forenede Stater, 21231
- Johns Hopkins University School of Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Male or female patients older than 18 with clinical diagnosis of distal pancreas adenocarcinoma
Exclusion Criteria:
- Patients with T4 or M1 disease, R2 resection margin, preoperative therapy, or if adjuvant therapy status was unknown.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Patients with distal pancreatic cancer
Patients with distal pancreatic cancer amenable to a laparoscopic distal pancreatectomy
|
Six cycles of Gemcitabine will be given.
Each cycle of Gemcitabine comprises of Gemcitabine 1000 mg/m2 as a 30 minute infusion once weekly for 3 weeks with a fourth week off.
Laparoscopic resection of the distal pancreas
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To determine if it is safe to administer gemcitabine to patients with pancreatic cancer one week after laparoscopic distal pancreatectomy.
Tidsramme: 1 year
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To determine the if the 1-year survival in patients with pancreatic cancer is improved with administration of gemcitabine one week following laparoscopic distal pancreatectomy
Tidsramme: 1 year
|
1 year
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Martin A Makary, MD, MPH, Johns Hopkins University Department of Surgery
Publikationer og nyttige links
Generelle publikationer
- Regine WF, Winter KA, Abrams RA, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Kudrimoti MR, Fromm ML, Haddock MG, Schaefer P, Willett CG, Rich TA. Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial. JAMA. 2008 Mar 5;299(9):1019-26. doi: 10.1001/jama.299.9.1019. Erratum In: JAMA. 2008 Apr 23/30;299(16):1902.
- Crane CH, Abbruzzese JL, Evans DB, Wolff RA, Ballo MT, Delclos M, Milas L, Mason K, Charnsangavej C, Pisters PW, Lee JE, Lenzi R, Vauthey JN, Wong AB, Phan T, Nguyen Q, Janjan NA. Is the therapeutic index better with gemcitabine-based chemoradiation than with 5-fluorouracil-based chemoradiation in locally advanced pancreatic cancer? Int J Radiat Oncol Biol Phys. 2002 Apr 1;52(5):1293-302. doi: 10.1016/s0360-3016(01)02740-7.
- Kachnic LA, Shaw JE, Manning MA, Lauve AD, Neifeld JP. Gemcitabine following radiotherapy with concurrent 5-fluorouracil for nonmetastatic adenocarcinoma of the pancreas. Int J Cancer. 2001 Apr 20;96(2):132-9. doi: 10.1002/ijc.1008.
Datoer for undersøgelser
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Sygdomme i det endokrine system
- Neoplasmer i fordøjelsessystemet
- Neoplasmer i endokrine kirtler
- Pancreassygdomme
- Bugspytkirtel neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Gemcitabin
Andre undersøgelses-id-numre
- NA_00031399
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Kliniske forsøg med Bugspytkirtel neoplasmer
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Guangzhou First People's HospitalAfsluttet
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Richard HungerMedizinische Hochschule Brandenburg Theodor FontaneAfsluttetVolume-Outcome Relation i Pancreatic Surgery
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Tianjin Medical University Cancer Institute and...Ikke rekrutterer endnuPDAC - Pancreatic Ductal Adenocarcinoma
-
Sun Yat-sen UniversityRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaKina
-
Cedars-Sinai Medical CenterRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaForenede Stater
-
Azienda Ospedaliera Universitaria Integrata VeronaRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaItalien
-
Azienda Ospedaliera Universitaria Integrata VeronaRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaItalien
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Washington University School of MedicineUniversity of Oklahoma Medical Center; Northwestern University Chicago... og andre samarbejdspartnereAfsluttet
-
Radboud University Medical CenterDutch Cancer SocietyRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaHolland
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Imperial College LondonThe Leeds Teaching Hospitals NHS Trust; Sheffield Teaching Hospitals NHS... og andre samarbejdspartnereRekrutteringKræft i bugspytkirtlen | PDAC - Pancreatic Ductal AdenocarcinomaDet Forenede Kongerige
Kliniske forsøg med Gemcitabine/Gemzar
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Patrick Dillon, MDRekrutteringBrystkræft | BrystneoplasmerForenede Stater
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AmgenAfsluttetAdenocarcinom i bugspytkirtlen | Lokalt avanceret | UopretteligSpanien, Belgien, Danmark, Polen, Forenede Stater, Korea, Republikken, Den Russiske Føderation, Østrig, Portugal, Det Forenede Kongerige, Tyskland, Ungarn, Tjekkiet
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North Eastern German Society of Gynaecological...Novartis Pharmaceuticals; medac GmbHAktiv, ikke rekrutterende
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University of California, IrvineAfsluttetCarcinom, overgangscelleForenede Stater
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National Institute of CancerologíaInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; Instituto...Rekruttering
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Shanghai Jiao Tong University School of MedicineShanghai 10th People's Hospital; Jiangxi Provincial Cancer Hospital; Shanghai... og andre samarbejdspartnereRekrutteringTilbagevendende ikke-småcellet lungekræftKina
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University of Colorado, DenverChildren's Hospital ColoradoAktiv, ikke rekrutterendeDiffus Intrinsic Pontine GliomForenede Stater
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Columbia UniversityAfsluttetBugspytkirtelkræft Stadium IVAForenede Stater
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Emory UniversityAfsluttetBugspytkirtel neoplasmer | CholangiocarcinomForenede Stater
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K-Group, Beta, Inc., a wholly owned subsidiary...Aktiv, ikke rekrutterendeOsteosarkomForenede Stater, Frankrig