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- Klinische proef NCT00002495
SWOG-9133 RT w/ or w/o Doxorubicin and Vinblastine in Stage I or Stage II Hodgkin's Disease
Randomized Trial of Subtotal Nodal Irradiation Versus Doxorubicin, Vinblastine and Subtotal Nodal Irradiation for Stage I-IIA Hodgkin's Disease
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: Randomized phase III trial to compare the effectiveness of radiation therapy with or without doxorubicin and vinblastine in treating patients with stage I or stage II Hodgkin's disease.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES: I. Compare progression-free and overall survival of patients with clinical Stage IA/IIA Hodgkin's disease who have not undergone laparotomy and who are randomized to treatment with subtotal nodal irradiation with vs. without 3 courses of doxorubicin/vinblastine. II. Compare the long-term toxicities associated with these treatments, including cardiopulmonary toxicity, secondary malignancies, and infertility. III. Identify subgroups of patients (based on age, gender, tumor histology, number of disease sites, and presence of high neck presentation) that are particularly responsive to these treatments.
OUTLINE: Randomized study. Arm I: Radiotherapy. Subtotal nodal irradiation using megavoltage equipment (4-10 MeV). Arm II: 2-Drug Combination Chemotherapy followed by Radiotherapy. Doxorubicin, DOX, NSC-123127; Vinblastine, VBL, NSC-49842; followed by subtotal nodal irradiation as in Arm I.
PROJECTED ACCRUAL: 210 patients/arm will be enrolled over about 7 years.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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California
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La Jolla, California, Verenigde Staten, 92093-0658
- University of California San Diego Cancer Center
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Delaware
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Wilmington, Delaware, Verenigde Staten, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Verenigde Staten, 20307-5000
- Walter Reed Army Medical Center
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Florida
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Miami Beach, Florida, Verenigde Staten, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, Verenigde Staten, 60637
- University of Chicago Cancer Research Center
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Iowa
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Iowa City, Iowa, Verenigde Staten, 52242
- University of Iowa Hospitals and Clinics
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Massachusetts
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Worcester, Massachusetts, Verenigde Staten, 01655
- University of Massachusetts Memorial Medical Center
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55455
- University of Minnesota Cancer Center
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Missouri
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Columbia, Missouri, Verenigde Staten, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, Verenigde Staten, 63110
- Barnes-Jewish Hospital
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Verenigde Staten, 03756
- Norris Cotton Cancer Center
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New York
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Buffalo, New York, Verenigde Staten, 14263-0001
- Roswell Park Cancer Institute
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Manhasset, New York, Verenigde Staten, 11030
- CCOP - North Shore University Hospital
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New York, New York, Verenigde Staten, 10029
- Mount Sinai Medical Center, NY
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Syracuse, New York, Verenigde Staten, 13210
- State University of New York - Upstate Medical University
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North Carolina
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Winston-Salem, North Carolina, Verenigde Staten, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, Verenigde Staten, 27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
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Rhode Island
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Providence, Rhode Island, Verenigde Staten, 02903
- Rhode Island Hospital
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Tennessee
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Memphis, Tennessee, Verenigde Staten, 38163
- University of Tennessee, Memphis Cancer Center
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Vermont
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Burlington, Vermont, Verenigde Staten, 05401-3498
- Vermont Cancer Center
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Virginia
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Richmond, Virginia, Verenigde Staten, 23298-0037
- MBCCOP - Massey Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
DISEASE CHARACTERISTICS: Biopsy-proven Hodgkin's disease, subclassified according to the Rye system Clinical Stages IA, IEA, IIA, and IIEA according to modified Ann Arbor system Staging laparotomy not allowed Completely resected disease allowed Residual disease, if present, must be bidimensionally measurable No mediastinal mass greater than 1/3 the maximum chest diameter No infradiaphragmatic presentation No pericardial E lesions (small pericardial effusions in the absence of nodular pericardial disease allowed) Concurrent registration on protocol SWOG-9208 (quality-of-life study) required unless patient does not understand or read English
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: SWOG 0-2 Hematopoietic: AGC at least 2,000 Platelets within normal limits Hepatic: Bilirubin within normal limits Renal: Creatinine within normal limits Cardiovascular: LVEF normal No serious EKG abnormality Pulmonary: No serious pulmonary condition Other: No serious medical condition other than Hodgkin's disease No known AIDS or HIV-associated complex No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer Adequately treated in situ carcinoma of the cervix No pregnant or lactating women Adequate contraception required of fertile patients Blood/body fluid analyses to determine eligibility completed within 14 days prior to registration; imaging studies for tumor measurement completed within 28 days prior to registration; screening exams other than blood/body fluid analyses, and imaging studies of nonmeasurable disease or uninvolved organs completed within 42 days prior to registration
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy for any reason Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for any reason Surgery: No staging laparotomy
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Nodal RT
subtotal nodal irradiation will consist of mantle and periaortic/spleen fields treated sequentially.
Total dose 3600-4000 cGy over 20 fractions.
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3600-4000 cGy delivered over 20 fractions
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Experimenteel: Chemotherapy + Nodal RT
3 cycles (28 days each) of chemotherapy (doxorubicin 25 mg/m^2 on days 1 and 15, vinblastine 6 mg/m^2 on days 1 and 15).
Four weeks after last cycle, subtotal nodal irradiation (total dose 3600-4000 cGy over 20 fractions) will be given as described for the Nodal RT arm.
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3600-4000 cGy delivered over 20 fractions
25 mg/m^2 on days 1 and 15
6 mg/m^2 on days 1 and 15
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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progression-free survival
Tijdsspanne: every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter
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every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter
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overall survival
Tijdsspanne: every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter
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every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Oliver W. Press, MD, PhD, University of Washington
- Studie stoel: Todd H. Wasserman, MD, Washington University Siteman Cancer Center
Publicaties en nuttige links
Algemene publicaties
- Ganz PA, Moinpour CM, McCoy S, et al.: Predictors of vitality (energy/fatigue) in early stage Hodgkin's disease (HD): results from Southwest Oncology Group (SWOG) study 9133. [Abstract] J Clin Oncol 22 (Suppl 14): A-6546, 569s, 2004.
- Ganz PA, Moinpour CM, Pauler DK, Kornblith AB, Gaynor ER, Balcerzak SP, Gatti GS, Erba HP, McCoy S, Press OW, Fisher RI. Health status and quality of life in patients with early-stage Hodgkin's disease treated on Southwest Oncology Group Study 9133. J Clin Oncol. 2003 Sep 15;21(18):3512-9. doi: 10.1200/JCO.2003.01.044. Erratum In: J Clin Oncol. 2013 Jun 10;31(17):2231-2.
- Press OW, LeBlanc M, Lichter AS, Grogan TM, Unger JM, Wasserman TH, Gaynor ER, Peterson BA, Miller TP, Fisher RI. Phase III randomized intergroup trial of subtotal lymphoid irradiation versus doxorubicin, vinblastine, and subtotal lymphoid irradiation for stage IA to IIA Hodgkin's disease. J Clin Oncol. 2001 Nov 15;19(22):4238-44. doi: 10.1200/JCO.2001.19.22.4238.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Neoplasmata
- Lymfoproliferatieve aandoeningen
- Lymfatische ziekten
- Immunoproliferatieve aandoeningen
- Lymfoom
- Ziekte van Hodgkin
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, fytogeen
- Topoisomerase II-remmers
- Topoisomeraseremmers
- Antibiotica, antineoplastiek
- Doxorubicine
- Liposomale doxorubicine
- Vinblastine
Andere studie-ID-nummers
- CDR0000077691
- U10CA032102 (Subsidie/contract van de Amerikaanse NIH)
- SWOG-9133 (Andere identificatie: SWOG)
- CLB-9391 (Andere identificatie: CALGB)
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