Early Chemotherapy Intensification in Interim-Positron Emission Tomography (PET) Positive Hodgkin Lymphoma
NCT ID: NCT00877747
Last Updated: 2015-10-19
Study Results
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Basic Information
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UNKNOWN
160 participants
OBSERVATIONAL
2006-01-31
2015-10-31
Brief Summary
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From January 2006 GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) suggested an early intensification of chemotherapy with BEACOPP \[Bleomycin, Etoposide, Adriamycin (doxorubicin), Cyclophosphamide, Oncovin (vincristine), Procarbazine, and Prednisone\](4 escalated + 4 baseline cycles) for all the HL patients with a positive PET-2 after 2 ABVD courses. The investigators retrospectively recorded and analyzed these data in order to evaluate if this strategy could be of benefit for this subset of patients.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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PET2 negative
Patients with negative early interim PET after 2 courses of ABVD who continued therapy with ABVD
No interventions assigned to this group
PET2 positive
Patients with positive early interim PET after 2 courses of ABVD who changed their therapy to BEACOPP
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age 16-80
* Not previously treated
* Stage IIB to IVB or stage IIA with adverse prognostic factors (more than 3 nodal sites, ESR \> 50 mm, bulky lesion)
* Written informed consent
Exclusion Criteria
* Concomitant or previously treated neoplastic disorder less than 5 years before the diagnosis of Hodgkin's lymphoma
* Psychiatric disorders
* Uncontrolled infectious disease
* Impaired cardiac (EF \< 50%) or renal (creatinine clearance \< 60 ml/m)function
* Pregnancy and lactation
* Uncompensated diabetes mellitus and fasting glucose levels over 200 mg/dl
16 Years
80 Years
ALL
No
Sponsors
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Ospedale Santa Croce-Carle Cuneo
OTHER
Responsible Party
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DR. ANDREA GALLAMINI
Professor
Principal Investigators
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Andrea Gallamini, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Santa Croce e Carle
Locations
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Azienda Ospedaliera Santa Croce e Carle
Cuneo, , Italy
Countries
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References
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Gallamini A, Hutchings M, Rigacci L, Specht L, Merli F, Hansen M, Patti C, Loft A, Di Raimondo F, D'Amore F, Biggi A, Vitolo U, Stelitano C, Sancetta R, Trentin L, Luminari S, Iannitto E, Viviani S, Pierri I, Levis A. Early interim 2-[18F]fluoro-2-deoxy-D-glucose positron emission tomography is prognostically superior to international prognostic score in advanced-stage Hodgkin's lymphoma: a report from a joint Italian-Danish study. J Clin Oncol. 2007 Aug 20;25(24):3746-52. doi: 10.1200/JCO.2007.11.6525. Epub 2007 Jul 23.
Gallamini A, Patti C, Viviani S, Rossi A, Fiore F, Di Raimondo F, Cantonetti M, Stelitano C, Feldman T, Gavarotti P, Sorasio R, Mule A, Leone M, Rambaldi A, Biggi A, Barrington S, Fallanca F, Ficola U, Chauvie S, Gianni AM; Gruppo Italiano Terapie Innovative nei Linfomi (GITIL). Early chemotherapy intensification with BEACOPP in advanced-stage Hodgkin lymphoma patients with a interim-PET positive after two ABVD courses. Br J Haematol. 2011 Mar;152(5):551-60. doi: 10.1111/j.1365-2141.2010.08485.x. Epub 2010 Dec 20.
Other Identifiers
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HD-PET-intens-retr
Identifier Type: -
Identifier Source: org_study_id
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