HD11 for Intermediate Stages

NCT ID: NCT00264953

Last Updated: 2011-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1395 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-05-31

Brief Summary

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This study is designed to (1) compare the efficacy of the BEACOPP regimen with that of ABVD as a 4-cycle chemotherapy combined with an involved field irradiation and (2) to define the optimum radiation dose comparing of 30 to 20 Gy in the same context.

Detailed Description

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Conditions

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Hodgkin´s Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

4x ABVD plus 30Gy IF-RT

Group Type ACTIVE_COMPARATOR

Adriamycin

Intervention Type DRUG

Bleomycin

Intervention Type DRUG

Vinblastine

Intervention Type DRUG

DTIC

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

20 or 30Gy IF-RT

C

4x BEACOPP baseline plus 30Gy IF-RT

Group Type EXPERIMENTAL

Adriamycin

Intervention Type DRUG

Bleomycin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Procarbazine

Intervention Type DRUG

Prednisone

Intervention Type DRUG

Vincristine

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

20 or 30Gy IF-RT

B

4x ABVD plus 20Gy IF-RT

Group Type EXPERIMENTAL

Adriamycin

Intervention Type DRUG

Bleomycin

Intervention Type DRUG

Vinblastine

Intervention Type DRUG

DTIC

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

20 or 30Gy IF-RT

D

4x BEACOPP baseline plus 20Gy IF-RT

Group Type EXPERIMENTAL

Adriamycin

Intervention Type DRUG

Bleomycin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Procarbazine

Intervention Type DRUG

Prednisone

Intervention Type DRUG

Vincristine

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

20 or 30Gy IF-RT

Interventions

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Adriamycin

Intervention Type DRUG

Bleomycin

Intervention Type DRUG

Vinblastine

Intervention Type DRUG

DTIC

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Procarbazine

Intervention Type DRUG

Prednisone

Intervention Type DRUG

Vincristine

Intervention Type DRUG

radiation therapy

20 or 30Gy IF-RT

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Hodgkin´s lymphoma (histologically proven)
* CS (PS) IA, IB, IIA, with one of the risk factors a-d CS (PS) IIB only with risk factor c or d

1. bulky mediastinal mass (\> 1/3 maximum transverse thorax diameter)
2. extranodal involvement
3. ESR \> 50 (A), \> 30 (B-symptoms)
4. 3 or more lymph node areas involved
* written informaed consent

Exclusion Criteria

* Leukocytes \<3000/microl
* Platelets \<100000/microl
* Hodgkin´s Disease as "composite lymphoma"
* Activity index (WHO) \< grade 2
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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German Hodgkin Study Group

Principal Investigators

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Volker Diehl, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

References

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Eich HT, Diehl V, Gorgen H, Pabst T, Markova J, Debus J, Ho A, Dorken B, Rank A, Grosu AL, Wiegel T, Karstens JH, Greil R, Willich N, Schmidberger H, Dohner H, Borchmann P, Muller-Hermelink HK, Muller RP, Engert A. Intensified chemotherapy and dose-reduced involved-field radiotherapy in patients with early unfavorable Hodgkin's lymphoma: final analysis of the German Hodgkin Study Group HD11 trial. J Clin Oncol. 2010 Sep 20;28(27):4199-206. doi: 10.1200/JCO.2010.29.8018. Epub 2010 Aug 16.

Reference Type RESULT
PMID: 20713848 (View on PubMed)

Hay AE, Klimm B, Chen BE, Goergen H, Shepherd LE, Fuchs M, Gospodarowicz MK, Borchmann P, Connors JM, Markova J, Crump M, Lohri A, Winter JN, Dorken B, Pearcey RG, Diehl V, Horning SJ, Eich HT, Engert A, Meyer RM; Conducted by the NCIC Clinical Trials Group (Canada) and German Hodgkin Study Group (GHSG). An individual patient-data comparison of combined modality therapy and ABVD alone for patients with limited-stage Hodgkin lymphoma. Ann Oncol. 2013 Dec;24(12):3065-9. doi: 10.1093/annonc/mdt389. Epub 2013 Oct 11.

Reference Type DERIVED
PMID: 24121121 (View on PubMed)

Boll B, Gorgen H, Fuchs M, Pluetschow A, Eich HT, Bargetzi MJ, Weidmann E, Junghanss C, Greil R, Scherpe A, Schmalz O, Eichenauer DA, von Tresckow B, Rothe A, Diehl V, Engert A, Borchmann P. ABVD in older patients with early-stage Hodgkin lymphoma treated within the German Hodgkin Study Group HD10 and HD11 trials. J Clin Oncol. 2013 Apr 20;31(12):1522-9. doi: 10.1200/JCO.2012.45.4181. Epub 2013 Mar 18.

Reference Type DERIVED
PMID: 23509310 (View on PubMed)

Related Links

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http://www.lymphome.de/Gruppen/GHSG/

Description od study in German (Website of the Competence Network Malignant Lymphoma)

Other Identifiers

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HD11

Identifier Type: -

Identifier Source: org_study_id

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