AzTrials
AzTrials

Hodgkin DiseasePhase 4NCT00188149

Optimization of the Primary Therapy for Patients With Hodgkin's Disease and Evaluation of PET

A Phase 4 study testing Combined chemotherapy (ABVD, BACOPP-D) and Radiation therapy in people with Hodgkin Disease, run by University Hospital Carl Gustav Carus at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Prognosis of patients with Hodgkin´s lymphoma (HL) has been improved significantly over the last decade. Therefore, the impact of treatment associated long-term toxicities and late effects such as second cancers increased. Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
Hodgkin Disease
What is being tested?
Combined chemotherapy (ABVD, BACOPP-D) and Radiation therapy
Type of treatment
Surgery or procedure
How many people
300 participants
Where
1 siteGermany
Study dates
May 2000to Dec 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically confirmed Hodgkin´s Lymphoma (WHO Classification 1999)
  • Classical Hodgkin Lymphoma: Nodular sclerosis (type 1 and 2) / Mixed type / Lymphocyte depleted type / Lymphocyte rich type
  • 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
Show all 23Show fewer
  • Histologically confirmed Hodgkin´s Lymphoma (WHO Classification 1999)
  • Classical Hodgkin´s Lymphoma: Nodular sclerosis (type 1 and 2) / Mixed type / Lymphocyte depleted type / Lymphocyte rich type
  • Nodular lymphocyte-predominant Hodgkin Lymphoma
  • Patients in stage
  • 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
  • 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)
  • Classical Hodgkin's Lymphoma (Hodgkin's desease): Nodular sclerosis (type 1 and 2) / Mixed type / Lymphocyte depleted type / Lymphocyte rich type
  • Nodular lymphocyte-predominant Hodgkin Lymphoma
  • Patients in stage
  • 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
  • Clinical stage (CS) III
  • Clinical stage (CS) IV
  • Age between 16 and 65
  • Written informed consent

Who cannot join

  • Poor general condition not related to the lymphoma (ECOG perfomance status 3 or 4; Karnofsky Index < 50 %)
  • 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

Trial locations and contacts

1 site in 1 country.

Ralph Naumann, MD contact

458-3855 ext. +49 351

Ralph.Naumann@uniklinikum-dresden.de

Germany1 site, 1 recruiting

  • Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav Carus

    Dresden, Saxony, 01307

    Ralph Naumann, MD

    Recruiting

Other trials in Germany

About this study

Official title: Optimization of the Primary Therapy for Patients With Hodgkin's Lymphoma and Evaluation of the Positron Emission Tomography (PET) as a Diagnostic Tool for Primary Staging and Assessment of the Effects of the Therapy

Prognosis of patients with Hodgkin´s lymphoma (HL) has been improved significantly over the last decade. Therefore, the impact of treatment associated long-term toxicities and late effects such as second cancers increased. The purpose of this prospective multicenter trial is to show the feasibility of the treatment with ABVD alone in patients with limited stage (HL1) and intermediate stage (HL2) disease and of an intensified etoposide-free chemotherapy regimen for patients with advanced disease (HL3) including 18F-FDG-PET evaluation.

Read the detailed description

The aim in limited and intermediate stages is to reduce the toxicity by omitting the subsequent radiotherapy in patients with complete remission after ABVD chemotherapy. Patients with limited disease receive four cycles, patients with intermediate disease (according to the criteria of the German Hodgkin Study group, GHSG) receice six cycles of ABVD. In case of residual mass (> 1.5 cm), additional involved field irradiation is planned. The aim in advanced disease using BACOPP-D regimen which includes cyclophosphamide, adriamycin, dacarbazine, procarbazine, prednisolone, bleomycin and vincristine, is to reduce the hematological toxicity and the secondary leukemias by omitting etoposide (in comparison to the BEACOPP escalated regimen). All patients receive eight cycles of the BACOPP-D regimen. In case of residual mass (> 1.5 cm), additional involved field irradiation is planned. Additionally, we want to evaluate the CT- and PET-based remission status after chemotherapy and at final staging.

Conditions
Hodgkin Disease
Being tested
Combined chemotherapy (ABVD, BACOPP-D), Radiation therapy
Keywords
Hodgkin's Lymphoma, Chemotherapy, Radiation therapy, PET
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined chemotherapy (ABVD, BACOPP-D)Drug

  • Radiation therapyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. - Feasibility and acute toxicity of the therapy

  2. - The Free from Therapy Failure (FFTF) rate after one year

  3. - Event-Free Survival (EFS) rate and overall survival rate

  4. - Evaluation of the PET as a diagnostic tool for the primary tumor staging as well for assessment of the effects of the therapy

Secondary outcomes (2)

  1. - Evaluation of the quality of life of the patients during and after the therapy

  2. - Occurence of late toxicity after the end of the therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startMay 2000
  3. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00188149
Sponsor's protocol ID
CGC05MK1002
Status last verified
Sep 2005
First submitted
10 Sep 2005
Last updated
29 Dec 2005
Results posted
No

Publications

  • 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.

    PubMed 1383107

  • 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.

    PubMed 1740677

  • 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.

    PubMed 1383821

  • 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.

    PubMed 7693881

  • 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.

    PubMed 1389523

  • 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.

    PubMed 9093722

  • Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982 Mar;38(1):143-51.

    PubMed 7082756

  • GEHAN EA. A GENERALIZED WILCOXON TEST FOR COMPARING ARBITRARILY SINGLY-CENSORED SAMPLES. Biometrika. 1965 Jun;52:203-23. No abstract available.

    PubMed 14341275

  • 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.

    PubMed 9164180

  • 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.

    PubMed 2033427

  • 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.

    PubMed 831755

  • 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.

    PubMed 9373210

  • 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.

    PubMed 8823321

  • Seegenschmiedt MH. Interdisciplinary documentation of treatment side effects in oncology. Present status and perspectives. Strahlenther Onkol. 1998 Nov;174 Suppl 3:25-9.

    PubMed 9830452

  • 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.

    PubMed 9508163

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Combined chemotherapy (ABVD, BACOPP-D) and Radiation therapy in people with Hodgkin Disease, run by University Hospital Carl Gustav Carus at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ralph Naumann, MD (458-3855 ext. +49 351, Ralph.Naumann@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

- Feasibility and acute toxicity of the therapy. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00188149, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2005.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in