- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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California
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La Jolla, California, Forente stater, 92093-0658
- University of California San Diego Cancer Center
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Delaware
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Wilmington, Delaware, Forente stater, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Forente stater, 20307-5000
- Walter Reed Army Medical Center
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Florida
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Miami Beach, Florida, Forente stater, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, Forente stater, 60637
- University of Chicago Cancer Research Center
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Iowa
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Iowa City, Iowa, Forente stater, 52242
- University of Iowa Hospitals and Clinics
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Massachusetts
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Worcester, Massachusetts, Forente stater, 01655
- University of Massachusetts Memorial Medical Center
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55455
- University of Minnesota Cancer Center
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Missouri
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Columbia, Missouri, Forente stater, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, Forente stater, 63110
- Barnes-Jewish Hospital
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Nevada
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Las Vegas, Nevada, Forente stater, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756
- Norris Cotton Cancer Center
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New York
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Buffalo, New York, Forente stater, 14263-0001
- Roswell Park Cancer Institute
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Manhasset, New York, Forente stater, 11030
- CCOP - North Shore University Hospital
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New York, New York, Forente stater, 10029
- Mount Sinai Medical Center, NY
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Syracuse, New York, Forente stater, 13210
- State University of New York - Upstate Medical University
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North Carolina
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Winston-Salem, North Carolina, Forente stater, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, Forente stater, 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, Forente stater, 02903
- Rhode Island Hospital
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Tennessee
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Memphis, Tennessee, Forente stater, 38163
- University of Tennessee, Memphis Cancer Center
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Vermont
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Burlington, Vermont, Forente stater, 05401-3498
- Vermont Cancer Center
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Virginia
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Richmond, Virginia, Forente stater, 23298-0037
- MBCCOP - Massey Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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progression-free survival
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Oliver W. Press, MD, PhD, University of Washington
- Studiestol: Todd H. Wasserman, MD, Washington University Siteman Cancer Center
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
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 (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Lymfom
- Hodgkins sykdom
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Antineoplastiske midler, fytogene
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Antibiotika, antineoplastisk
- Doxorubicin
- Liposomal doksorubicin
- Vinblastin
Andre studie-ID-numre
- CDR0000077691
- U10CA032102 (U.S. NIH-stipend/kontrakt)
- SWOG-9133 (Annen identifikator: SWOG)
- CLB-9391 (Annen identifikator: CALGB)
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