Optimization of the Primary Therapy for Patients With Hodgkin's Disease and Evaluation of PET
NCT ID: NCT00188149
Last Updated: 2005-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
300 participants
INTERVENTIONAL
2000-05-31
2007-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Combined chemotherapy (ABVD, BACOPP-D)
Radiation therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Classical Hodgkin Lymphoma: Nodular sclerosis (type 1 and 2) / Mixed type / Lymphocyte depleted type / Lymphocyte rich type
2. Nodular lymphocyte-predominant Hodgkin Lymphoma
* Patients in stage: Clinical stage (CS) I without risk factors / CS II without risk factors
* Age between 16 and 75
* Written informed consent
* Histologically confirmed Hodgkin´s Lymphoma (WHO Classification 1999)
1. Classical Hodgkin´s Lymphoma: Nodular sclerosis (type 1 and 2) / Mixed type / Lymphocyte depleted type / Lymphocyte rich type
2. Nodular lymphocyte-predominant Hodgkin Lymphoma
* Patients in stage
1. Clinical stage (CS) I,II A with risk factors: Large mediastinal tumor (\>1/3 of the maximal diameter of the thoracic cavity) / Extranodal disease / Sedimentation rate ≥ 50 mm/h for patients without B-symptomes or ≥ 30 mm/h for patients with B-symptomes / ≥ 3 lymph node areas infiltrated with tumor cells
2. Clinical stage (CS) II B with risk factors: Sedimentation rate ≥ 50 mm/h for patients without B-symptomes or ≥ 30 mm/h for patients with B-symptomes / ≥ 3 lymph node areas infiltrated with tumor cells
* Age between 16 and 75
* Written informed consent
* Histologically confirmed Hodgkin´s Lymphoma (WHO Classification 1999)
1. Classical Hodgkin's Lymphoma (Hodgkin's desease): Nodular sclerosis (type 1 and 2) / Mixed type / Lymphocyte depleted type / Lymphocyte rich type
2. Nodular lymphocyte-predominant Hodgkin Lymphoma
* Patients in stage
1. Clinical stage (CS) II B with minimum one of the following risk factors: Large mediastinal tumor (≥1/3 of the maximal diameter of the thoracic cavity) / Extranodal disease
2. Clinical stage (CS) III
3. Clinical stage (CS) IV
* Age between 16 and 65
* Written informed consent
Exclusion Criteria
* Severe concomitant diseases: cardiac insufficiency (NYHA grade III or IV) / chronic respiratory insufficiency with hypoxemia / Hepatic insufficiency (cirrhosis, Hepatitis B or C / chronic renal insufficiency / HIV infection or other out-of-control infections / hematopoetic insufficiency (Leukocytes \< 3000/µl; Thrombocytes \< 100.000/µl / psychiatric diseases
* History of previous malignancy in the last 5 years
* Pregnancy
* Patients not likely to comply to the requirements stemming form the participation in the trial
16 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Technische Universität Dresden
OTHER
University Hospital Carl Gustav Carus
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ralph Naumann, MD
Role: PRINCIPAL_INVESTIGATOR
University Clinic "Carl Gustav Carus" Dresden
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav Carus
Dresden, Saxony, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ralph Naumann, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Anselmo AP, Bove M, Cartoni C, Damico C, Maurizi Enrici R, Falchetto Osti M, Biagini C. Combined modality (ABVD plus radiotherapy) versus radiotherapy in the management of early stage (IIA) Hodgkin's disease with mediastinal involvement. Haematologica. 1992 Mar-Apr;77(2):177-9.
Biti GP, Cimino G, Cartoni C, Magrini SM, Anselmo AP, Enrici RM, Bellesi GP, Bosi A, Papa G, Giannarelli D, et al. Extended-field radiotherapy is superior to MOPP chemotherapy for the treatment of pathologic stage I-IIA Hodgkin's disease: eight-year update of an Italian prospective randomized study. J Clin Oncol. 1992 Mar;10(3):378-82. doi: 10.1200/JCO.1992.10.3.378.
Canellos GP, Anderson JR, Propert KJ, Nissen N, Cooper MR, Henderson ES, Green MR, Gottlieb A, Peterson BA. Chemotherapy of advanced Hodgkin's disease with MOPP, ABVD, or MOPP alternating with ABVD. N Engl J Med. 1992 Nov 19;327(21):1478-84. doi: 10.1056/NEJM199211193272102.
Carde P, Hagenbeek A, Hayat M, Monconduit M, Thomas J, Burgers MJ, Noordijk EM, Tanguy A, Meerwaldt JH, Le Fur R, et al. Clinical staging versus laparotomy and combined modality with MOPP versus ABVD in early-stage Hodgkin's disease: the H6 twin randomized trials from the European Organization for Research and Treatment of Cancer Lymphoma Cooperative Group. J Clin Oncol. 1993 Nov;11(11):2258-72. doi: 10.1200/JCO.1993.11.11.2258.
Cosset JM, Henry-Amar M, Meerwaldt JH, Carde P, Noordijk EM, Thomas J, Burgers JM, Somers R, Hayat M, Tubiana M. The EORTC trials for limited stage Hodgkin's disease. The EORTC Lymphoma Cooperative Group. Eur J Cancer. 1992;28A(11):1847-50. doi: 10.1016/0959-8049(92)90018-w. No abstract available.
Diehl V, Sieber M, Ruffer U, Lathan B, Hasenclever D, Pfreundschuh M, Loeffler M, Lieberz D, Koch P, Adler M, Tesch H. BEACOPP: an intensified chemotherapy regimen in advanced Hodgkin's disease. The German Hodgkin's Lymphoma Study Group. Ann Oncol. 1997 Feb;8(2):143-8. doi: 10.1023/a:1008294312741.
Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982 Mar;38(1):143-51.
GEHAN EA. A GENERALIZED WILCOXON TEST FOR COMPARING ARBITRARILY SINGLY-CENSORED SAMPLES. Biometrika. 1965 Jun;52:203-23. No abstract available.
Horning SJ, Hoppe RT, Mason J, Brown BW, Hancock SL, Baer D, Rosenberg SA. Stanford-Kaiser Permanente G1 study for clinical stage I to IIA Hodgkin's disease: subtotal lymphoid irradiation versus vinblastine, methotrexate, and bleomycin chemotherapy and regional irradiation. J Clin Oncol. 1997 May;15(5):1736-44. doi: 10.1200/JCO.1997.15.5.1736.
Longo DL, Glatstein E, Duffey PL, Young RC, Hubbard SM, Urba WJ, Wesley MN, Raubitschek A, Jaffe ES, Wiernik PH, et al. Radiation therapy versus combination chemotherapy in the treatment of early-stage Hodgkin's disease: seven-year results of a prospective randomized trial. J Clin Oncol. 1991 Jun;9(6):906-17. doi: 10.1200/JCO.1991.9.6.906.
Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. analysis and examples. Br J Cancer. 1977 Jan;35(1):1-39. doi: 10.1038/bjc.1977.1.
Ruiz-Arguelles GJ, Gomez-Almaguer D, Apreza-Molina MG. Chemotherapy alone may be an efficient alternative in the treatment of early stage Hodgkin's disease if optimal radiotherapy is not available. Leuk Lymphoma. 1997 Sep;27(1-2):179-83. doi: 10.3109/10428199709068285.
Salloum E, Doria R, Schubert W, Zelterman D, Holford T, Roberts KB, Farber LR, Kiehl RK, Cardinale J, Cooper DL. Second solid tumors in patients with Hodgkin's disease cured after radiation or chemotherapy plus adjuvant low-dose radiation. J Clin Oncol. 1996 Sep;14(9):2435-43. doi: 10.1200/JCO.1996.14.9.2435.
Seegenschmiedt MH. Interdisciplinary documentation of treatment side effects in oncology. Present status and perspectives. Strahlenther Onkol. 1998 Nov;174 Suppl 3:25-9.
Specht L, Gray RG, Clarke MJ, Peto R. Influence of more extensive radiotherapy and adjuvant chemotherapy on long-term outcome of early-stage Hodgkin's disease: a meta-analysis of 23 randomized trials involving 3,888 patients. International Hodgkin's Disease Collaborative Group. J Clin Oncol. 1998 Mar;16(3):830-43. doi: 10.1200/JCO.1998.16.3.830.
Wirth A, Corry J, Laidlaw C, Matthews J, Liew KH. Salvage radiotherapy for Hodgkin's disease following chemotherapy failure. Int J Radiat Oncol Biol Phys. 1997 Oct 1;39(3):599-607. doi: 10.1016/s0360-3016(97)00352-0.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CGC05MK1002
Identifier Type: -
Identifier Source: org_study_id