HD10 for Early Stages

NCT ID: NCT00265018

Last Updated: 2011-07-29

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

1370 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-05-31

Brief Summary

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This study is designed to find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.

Detailed Description

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Conditions

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Hodgkin´s Lymphoma

Keywords

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Hodgkin´s lymphoma early stages

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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Arm A

Group Type ACTIVE_COMPARATOR

Adriamycin

Intervention Type DRUG

Bleomycin

Intervention Type DRUG

Vinblastine

Intervention Type DRUG

DTIC

Intervention Type DRUG

30 Gy IF-RT

Intervention Type RADIATION

Arm B

Group Type EXPERIMENTAL

Adriamycin

Intervention Type DRUG

Bleomycin

Intervention Type DRUG

Vinblastine

Intervention Type DRUG

DTIC

Intervention Type DRUG

20 Gy IF-RT

Intervention Type RADIATION

Arm C

Group Type EXPERIMENTAL

Adriamycin

Intervention Type DRUG

Bleomycin

Intervention Type DRUG

Vinblastine

Intervention Type DRUG

DTIC

Intervention Type DRUG

30 Gy IF-RT

Intervention Type RADIATION

Arm D

Group Type EXPERIMENTAL

Adriamycin

Intervention Type DRUG

Bleomycin

Intervention Type DRUG

Vinblastine

Intervention Type DRUG

DTIC

Intervention Type DRUG

20 Gy IF-RT

Intervention Type RADIATION

Interventions

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Adriamycin

Intervention Type DRUG

Bleomycin

Intervention Type DRUG

Vinblastine

Intervention Type DRUG

DTIC

Intervention Type DRUG

30 Gy IF-RT

Intervention Type RADIATION

20 Gy IF-RT

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Hodgkin´s lymphoma (histologically proven)
* CS (PS) IA, IB, IIA,IIB without any of the following risk factors:

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

Principal Investigators

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Volker Diehl, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

References

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Engert A, Plutschow A, Eich HT, Lohri A, Dorken B, Borchmann P, Berger B, Greil R, Willborn KC, Wilhelm M, Debus J, Eble MJ, Sokler M, Ho A, Rank A, Ganser A, Trumper L, Bokemeyer C, Kirchner H, Schubert J, Kral Z, Fuchs M, Muller-Hermelink HK, Muller RP, Diehl V. Reduced treatment intensity in patients with early-stage Hodgkin's lymphoma. N Engl J Med. 2010 Aug 12;363(7):640-52. doi: 10.1056/NEJMoa1000067.

Reference Type RESULT
PMID: 20818855 (View on PubMed)

Sasse S, Goergen H, Plutschow A, Boll B, Eichenauer DA, Fuchs M, Behringer K, Zijlstra JM, Greil R, Markova J, Topp MS, Meissner J, Neubauer A, Baues C, Engert A, Borchmann P, von Tresckow B. Outcome of Patients With Early-Stage Infradiaphragmatic Hodgkin Lymphoma: A Comprehensive Analysis From the German Hodgkin Study Group. J Clin Oncol. 2018 Sep 1;36(25):2603-2611. doi: 10.1200/JCO.2018.78.7192. Epub 2018 Jul 10.

Reference Type DERIVED
PMID: 29989855 (View on PubMed)

Boll B, Goergen H, Behringer K, Brockelmann PJ, Hitz F, Kerkhoff A, Greil R, von Tresckow B, Eichenauer DA, Burkle C, Borchmann S, Fuchs M, Diehl V, Engert A, Borchmann P. Bleomycin in older early-stage favorable Hodgkin lymphoma patients: analysis of the German Hodgkin Study Group (GHSG) HD10 and HD13 trials. Blood. 2016 May 5;127(18):2189-92. doi: 10.1182/blood-2015-11-681064. Epub 2016 Feb 1.

Reference Type DERIVED
PMID: 26834240 (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 of study in Gereman (Website of the Competence Network Malignant Lymphoma

Other Identifiers

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HD10

Identifier Type: -

Identifier Source: org_study_id