- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00059826
Adjuvant Chemoradiotherapy and Interferon Alfa in Treating Patients With Resected Pancreatic Cancer
A Phase II Study of Interferon-Based Adjuvant Chemoradiation in Patients With Resected Pancreatic Adenocarcinoma
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Radiation therapy uses high-energy radiation from x-rays and other sources to kill tumor cells. Combining chemotherapy with interferon alfa and giving them with radiation therapy after surgery may kill any remaining tumor cells.
PURPOSE: Phase II trial to study the effectiveness of adjuvant chemoradiotherapy and interferon alfa in treating patients who have resected stage I, stage II, or stage III pancreatic cancer.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
- Determine the disease-free and overall survival of patients with resected pancreatic adenocarcinoma treated with adjuvant chemoradiotherapy comprising fluorouracil, cisplatin, and interferon alfa.
- Determine the rate and severity of acute and late toxic effects in patients treated with this regimen.
- Determine the local-regional disease control and distant disease control in patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Chemoradiotherapy (CRT): Patients receive fluorouracil IV continuously on days 1-38; cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36; and interferon alfa subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, and 38. Patients also undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38.
- Post-CRT chemotherapy: Beginning 4-6 weeks after the completion of CRT, patients receive fluorouracil IV continuously on days 1-42. Treatment repeats every 56 days for a total of two courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Florida
-
Gainesville, Florida, États-Unis, 32610-0232
- University of Florida Shands Cancer Center
-
-
Illinois
-
Chicago, Illinois, États-Unis, 60612
- Rush University Medical Center
-
-
Kentucky
-
Louisville, Kentucky, États-Unis, 40202
- James Graham Brown Cancer Center at University of Louisville
-
-
Massachusetts
-
Boston, Massachusetts, États-Unis, 02115
- Brigham and Women's Hospital
-
Boston, Massachusetts, États-Unis, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
-
Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital Cancer Center
-
-
Minnesota
-
Minneapolis, Minnesota, États-Unis, 55455
- Fairview University Medical Center - University Campus
-
-
New York
-
Buffalo, New York, États-Unis, 14263-0001
- Roswell Park Cancer Institute
-
New York, New York, États-Unis, 10021
- Memorial Sloan-Kettering Cancer Center
-
Rochester, New York, États-Unis, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
-
Tennessee
-
Nashville, Tennessee, États-Unis, 37232
- Vanderbilt-Ingram Cancer Center
-
-
Texas
-
Dallas, Texas, États-Unis, 75231
- Presbyterian Hospital of Dallas
-
Houston, Texas, États-Unis, 77030
- Baylor University Medical Center - Houston
-
-
Wisconsin
-
Milwaukee, Wisconsin, États-Unis, 53226
- Medical College of Wisconsin Cancer Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patient must be > 18 years of age.
- Patient must have a documented ECOG/Zubrod performance status of 0 or 1, within 7 days prior to registration.
Patient must have pathological stage T1-3, N0-1, M0 adenocarcinoma of the head of the pancreas according to the American Joint Committee on Cancer (AJCC) staging system.
- NOTE: The pathology report must be submitted to ACOSOG on the Pathology Report Shuttle CRF.
- Patient must have undergone a potentially curative gross total resection by pancreaticoduodenectomy (includes R0 [no residual tumor] or R1 [microscopic residual tumor]) within 56 days prior to beginning treatment. NOTE: The operative report must be submitted to ACOSOG on the Operative Report Shuttle CRF.
Patient must have stable or increasing weight in the 14 days prior to the start of treatment, otherwise supplemental nutrition (e.g. feeding jejunostomy, PEG, TPN) must be initiated prior to the start of treatment.6. Patient must have adequate bone marrow, hepatic and renal function, within 7 days prior to registration:
- WBC > 3,000 mm^3
- ANC > 1,500 mm^3
- hemoglobin > 9.5 mg/dl
- platelet count > 100,000 mm^3
- total bilirubin < 3 mg/dl
- AST (SGOT) < 2.0 times institutional upper limit of normal (ULN)
- ALT (SGPT) < 2.0 times institutional ULN
- alkaline phosphatase < 2.0 times institutional ULN
- serum creatinine < 1.5 times institutional ULN
7. Patient must have a baseline diagnostic CT scan of the chest and CT scan with IV contrast (or MRI) of abdomen/pelvis, within 30 days prior to registration, to exclude metastatic disease.
8. If female of childbearing potential, patient must have a negative urine or serum pregnancy test, within 7 days prior to registration. NOTE: Postmenopausal women must have been amenorrheic for at least 12 consecutive months to be considered not of childbearing potential.
9. Patient (male or female) of reproductive potential must agree to use medically acceptable contraception during the study. NOTE: Medically acceptable contraceptives include: (1) surgical sterilization, (2) approved hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD).
10. Patient, or the patient's legally acceptable representative, must sign and date an informed consent PRIOR to registration and the performance of any study related procedures.
11. Patient, or the patient's legally acceptable representative, must provide written authorization to allow the use and disclosure of their protected health information.
- NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration.
12. If patient is a cancer survivor, all of the following criteria must be met and documented in the patient's medical record:
- Patient has undergone potentially curative therapy for all prior malignancies.
- No evidence of prior malignancies for at least 5 years (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, or nonmelanoma skin cancer).
- No evidence of recurrence of any prior malignancy.
Exclusion Criteria:
- Patient has pancreaticoduodenectomy histopathology of adenosquamous carcinoma, ampullary carcinoma, carcinoid tumor, cystadenocarcinoma, cystadenoma, distal common bile duct carcinoma, duodenal carcinoma, or islet cell carcinoma.
- Patient is pregnant or lactating.
- Patient has recurrent pancreatic cancer.
- Patient has received prior systemic chemotherapy or radiotherapy for pancreatic cancer.
- Patient has received external beam photon (x-ray) therapy to the chest, abdomen or pelvis.
- Patient has received any biologic/ immunologic therapies.
- Patient has received chronic immunotherapy (e.g. prednisone or methotrexate) for collagen vascular disease or other chronic immunologic abnormality.
- Patient has a preexisting psychiatric condition, especially depression, or a history of severe psychiatric disorders.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Interferon-based chemoradiation therapy
Cycle 1: Chemoradiotherapy (CRT)
Cycles 2 and 3: Post-CRT Chemotherapy Post-CRT chemotherapy starts 4 - 6 weeks after completion of Cycle 1, unless the study physician deems further delay is necessary. Patients will be given 2 cycles of chemotherapy (cycles 2 and 3). -- 5-fluorouracil continuous infusion via an ambulatory infusion pump into a central venous catheter at 200 mg/m2/day for 6 weeks followed by 2 weeks of rest |
Autres noms:
IV
IV
Autres noms:
IV
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Overall survival at 18 months
Délai: at 18 months
|
at 18 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Toxicity
Délai: at 18 months
|
at 18 months
|
Survie sans maladie
Délai: à 18 mois
|
à 18 mois
|
Local-regional disease control
Délai: at 18 months
|
at 18 months
|
Distant disease control
Délai: at 18 months
|
at 18 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Vincent J. Picozzi, MD, Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center
Publications et liens utiles
Publications générales
- Picozzi VJ, Abrams RA, Decker PA, Traverso W, O'Reilly EM, Greeno E, Martin RC, Wilfong LS, Rothenberg ML, Posner MC, Pisters PW; American College of Surgeons Oncology Group. Multicenter phase II trial of adjuvant therapy for resected pancreatic cancer using cisplatin, 5-fluorouracil, and interferon-alfa-2b-based chemoradiation: ACOSOG Trial Z05031. Ann Oncol. 2011 Feb;22(2):348-54. doi: 10.1093/annonc/mdq384. Epub 2010 Jul 29.
- Picozzi VJ, Abrams RA, Traverso LW, et al.: ACOSOG Z05031: initial report of a multicenter, phase II trial of a novel chemoradiation protocol using cisplatin, 5-FU, and alpha- interferon as adjuvant therapy for resected pancreas cancer. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-125, 2008.
- Picozzi VJ, Abrams RA, Traverso LW, et al.: ACOSOG Z05031: report on a multicenter, phase II trial for adjuvant therapy of resected pancreatic cancer using cisplatin, 5- FU, and alpha-interferon. [Abstract] J Clin Oncol 26 (Suppl 15): A-4505, 2008.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Tumeurs
- Tumeurs par site
- Maladies du système endocrinien
- Tumeurs du système digestif
- Tumeurs des glandes endocrines
- Maladies pancréatiques
- Tumeurs pancréatiques
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Agents antiviraux
- Antimétabolites, Antinéoplasique
- Antimétabolites
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Interférons
- Interféron-alpha
- Fluorouracile
- Interféron alpha-2
Autres numéros d'identification d'étude
- ACOSOG-Z05031
- CDR0000298776 (Identificateur de registre: NCI Physician Data Query)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Radiothérapie
-
University Hospital Southampton NHS Foundation...ComplétéMaladie de l'artère coronaireRoyaume-Uni, Irlande
-
Seoul National University HospitalComplétéSténose de l'artère coronaire
-
Ajou University School of MedicineRésiliéSténose de l'artère coronaireCorée, République de
-
Medical University of South CarolinaNational Institute on Deafness and Other Communication Disorders (NIDCD)Actif, ne recrute pasAccident vasculaire cérébral | Aphasie | Aphasie Non FluentÉtats-Unis
-
Columbia UniversityRésilié
-
Seoul National University HospitalInje University; Keimyung University; Ajou UniversityInconnueSténose de l'artère coronaireCorée, République de
-
NeuroTronik Inc.InconnueInsuffisance cardiaque | Insuffisance cardiaque aiguëParaguay
-
NeuroTronik Inc.InconnueInsuffisance cardiaque aiguëPanama
-
University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale...ComplétéEn bonne santéSuisse
-
University of Alabama at BirminghamComplétéAccident vasculaire cérébral | Parésie du membre supérieur | AVC (Accident Cérébrovasculaire)États-Unis