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

Primary Purpose

Hodgkin Disease

Status

Unknown status

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Combined chemotherapy (ABVD, BACOPP-D)

Radiation therapy

About this trial

This is an interventional treatment trial for Hodgkin Disease focused on measuring Hodgkin's Lymphoma, Chemotherapy, Radiation therapy, PET

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (HL1): 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 Inclusion criteria (HL2): 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 Inclusion criteria (HL3): 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 Exclusion Criteria (HL1, HL2 and HL3): 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

Sites / Locations

Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav CarusRecruiting

Outcomes

Primary Outcome Measures

- Feasibility and acute toxicity of the therapy

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

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

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

Secondary Outcome Measures

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

- Occurence of late toxicity after the end of the therapy

Full Information

NCT ID

NCT00188149

First Posted

September 10, 2005

Last Updated

December 28, 2005

Sponsor

University Hospital Carl Gustav Carus

Collaborators

Technische Universität Dresden

1. Study Identification

Unique Protocol Identification Number

NCT00188149

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

May 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital Carl Gustav Carus

Collaborators

Technische Universität Dresden

4. Oversight

5. Study Description

Brief 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. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hodgkin Disease

Keywords

Hodgkin's Lymphoma, Chemotherapy, Radiation therapy, PET

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

300 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Combined chemotherapy (ABVD, BACOPP-D)

Intervention Type

Procedure

Intervention Name(s)

Radiation therapy

Primary Outcome Measure Information:

Title

- Feasibility and acute toxicity of the therapy

Title

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

Title

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

Title

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

Secondary Outcome Measure Information:

Title

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

Title

- Occurence of late toxicity after the end of the therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ralph Naumann, MD

Phone

458-3855

Ext

+49 351

Ralph.Naumann@uniklinikum-dresden.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ralph Naumann, MD

Organizational Affiliation

University Clinic "Carl Gustav Carus" Dresden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav Carus

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ralph Naumann, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

1383107

Citation

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.

Results Reference

background

PubMed Identifier

1740677

Citation

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.

Results Reference

background

PubMed Identifier

1383821

Citation

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.

Results Reference

background

PubMed Identifier

7693881

Citation

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.

Results Reference

background

PubMed Identifier

1389523

Citation

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.

Results Reference

background

PubMed Identifier

9093722

Citation

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.

Results Reference

background

PubMed Identifier

7082756

Citation

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

Results Reference

background

PubMed Identifier

14341275

Citation

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

Results Reference

background

PubMed Identifier

9164180

Citation

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.

Results Reference

background

PubMed Identifier

2033427

Citation

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.

Results Reference

background

PubMed Identifier

831755

Citation

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.

Results Reference

background

PubMed Identifier

9373210

Citation

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.

Results Reference

background

PubMed Identifier

8823321

Citation

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.

Results Reference

background

PubMed Identifier

9830452

Citation

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

Results Reference

background

PubMed Identifier

9508163

Citation

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.

Results Reference

background

PubMed Identifier

9336139

Citation

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.

Results Reference

background

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

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