HD12 for Advanced Stages

NCT ID: NCT00265031

Last Updated: 2012-06-25

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

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-31

Brief Summary

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This study is designed to test (1) whether the BEACOPP dosage can be reduced to baseline in the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is necessary following effective chemotherapy.

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

Interventions

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Cyclophosphamide

Intervention Type DRUG

Adriamycin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Procarbazine

Intervention Type DRUG

Prednisone

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Bleomycin

Intervention Type DRUG

radiation therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Hodgkin´s lymphoma (histologically proven)
* CS(PS) IIB with one or both of the risk factors:

1. bulky mediastinal mass (\> 1/3 of maximum transverse thorax diameter)
2. extranodal involvement
* CS(PS) III, IV
* 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

65 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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Borchmann P, Haverkamp H, Diehl V, Cerny T, Markova J, Ho AD, Eich HT, Mueller-Hermelink HK, Kanz L, Greil R, Rank A, Paulus U, Smardova L, Huber C, Dorken B, Nerl C, Krause SW, Mueller RP, Fuchs M, Engert A. Eight cycles of escalated-dose BEACOPP compared with four cycles of escalated-dose BEACOPP followed by four cycles of baseline-dose BEACOPP with or without radiotherapy in patients with advanced-stage hodgkin's lymphoma: final analysis of the HD12 trial of the German Hodgkin Study Group. J Clin Oncol. 2011 Nov 10;29(32):4234-42. doi: 10.1200/JCO.2010.33.9549. Epub 2011 Oct 11.

Reference Type RESULT
PMID: 21990399 (View on PubMed)

von Tresckow B, Kreissl S, Goergen H, Brockelmann PJ, Pabst T, Fridrik M, Rummel M, Jung W, Thiemer J, Sasse S, Burkle C, Baues C, Diehl V, Engert A, Borchmann P; German Hodgkin Study Group. Intensive treatment strategies in advanced-stage Hodgkin's lymphoma (HD9 and HD12): analysis of long-term survival in two randomised trials. Lancet Haematol. 2018 Oct;5(10):e462-e473. doi: 10.1016/S2352-3026(18)30140-6.

Reference Type DERIVED
PMID: 30290903 (View on PubMed)

Related Links

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

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

Other Identifiers

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HD12

Identifier Type: -

Identifier Source: org_study_id

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