- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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California
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La Jolla, California, Forenede Stater, 92093-0658
- University of California San Diego Cancer Center
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Delaware
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Wilmington, Delaware, Forenede Stater, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20307-5000
- Walter Reed Army Medical Center
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Florida
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Miami Beach, Florida, Forenede Stater, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago Cancer Research Center
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hospitals and Clinics
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Massachusetts
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Worcester, Massachusetts, Forenede Stater, 01655
- University of Massachusetts Memorial Medical Center
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota Cancer Center
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Missouri
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Columbia, Missouri, Forenede Stater, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, Forenede Stater, 63110
- Barnes-Jewish Hospital
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Norris Cotton Cancer Center
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New York
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Buffalo, New York, Forenede Stater, 14263-0001
- Roswell Park Cancer Institute
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Manhasset, New York, Forenede Stater, 11030
- CCOP - North Shore University Hospital
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New York, New York, Forenede Stater, 10029
- Mount Sinai Medical Center, NY
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Syracuse, New York, Forenede Stater, 13210
- State University of New York - Upstate Medical University
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North Carolina
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Winston-Salem, North Carolina, Forenede Stater, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, Forenede 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, Forenede Stater, 02903
- Rhode Island Hospital
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38163
- University of Tennessee, Memphis Cancer Center
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Vermont
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Burlington, Vermont, Forenede Stater, 05401-3498
- Vermont Cancer Center
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Virginia
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Richmond, Virginia, Forenede Stater, 23298-0037
- MBCCOP - Massey Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Oliver W. Press, MD, PhD, University of Washington
- Studiestol: Todd H. Wasserman, MD, Washington University Siteman Cancer Center
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Lymfom
- Hodgkins sygdom
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Antibiotika, antineoplastisk
- Doxorubicin
- Liposomal doxorubicin
- Vinblastin
Andre undersøgelses-id-numre
- CDR0000077691
- U10CA032102 (U.S. NIH-bevilling/kontrakt)
- SWOG-9133 (Anden identifikator: SWOG)
- CLB-9391 (Anden identifikator: CALGB)
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Kliniske forsøg med standard subtotal nodal irradiation
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)AfsluttetLeukæmiForenede Stater
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Baylor College of MedicineThe Methodist Hospital Research Institute; Center for Cell and Gene Therapy...AfsluttetAplastisk anæmiForenede Stater
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Washington University School of MedicineAfsluttet
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Sidney Kimmel Cancer Center at Thomas Jefferson...AfsluttetLymfom | Leukæmi | Hodgkins lymfom | Akut lymfatisk leukæmi | Kronisk lymfatisk leukæmi | AML | Akut myelogen leukæmi | Hæmatologisk malignitet | Myelom | Non-hodgkins lymfom | CLL | ALLEForenede Stater
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Medical College of WisconsinNational Cancer Institute (NCI); National Heart, Lung, and Blood Institute... og andre samarbejdspartnereAfsluttetAlvorlig aplastisk anæmiForenede Stater
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Medical College of WisconsinNational Heart, Lung, and Blood Institute (NHLBI); Dana-Farber Cancer Institute og andre samarbejdspartnereAfsluttetSeglcellesygdomForenede Stater
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Center for International Blood and Marrow Transplant...National Marrow Donor ProgramAfsluttetKronisk lymfatisk leukæmi (CLL) | Myelodysplastisk syndrom (MDS) | Akut myelogen leukæmi (AML) | Kemoterapi-følsomt lymfom | Akut lymfatisk leukæmi (ALL)/T-lymfoblastisk lymfom | Akut bifænotypisk leukæmi (ABL) | Akut udifferentieret leukæmi (AUL)Forenede Stater