NCT00264953 · CITED IN SOURCE DOCUMENTS

HD11 for Intermediate Stages

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2011-08-04

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: 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
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 16 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
4x ABVD plus 30Gy IF-RT
intervention Names
Drug: Adriamycin
Drug: Bleomycin
Drug: Vinblastine
Drug: DTIC
Radiation: radiation therapy
label
A
type
ACTIVE_COMPARATOR
description
4x BEACOPP baseline plus 30Gy IF-RT
intervention Names
Drug: Adriamycin
Drug: Bleomycin
Drug: Etoposide
Drug: Procarbazine
Drug: Prednisone
Drug: Vincristine
Radiation: radiation therapy
label
C
type
EXPERIMENTAL
description
4x ABVD plus 20Gy IF-RT
intervention Names
Drug: Adriamycin
Drug: Bleomycin
Drug: Vinblastine
Drug: DTIC
Radiation: radiation therapy
label
B
type
EXPERIMENTAL
description
4x BEACOPP baseline plus 20Gy IF-RT
intervention Names
Drug: Adriamycin
Drug: Bleomycin
Drug: Etoposide
Drug: Procarbazine
Drug: Prednisone
Drug: Vincristine
Radiation: radiation therapy
label
D
type
EXPERIMENTAL

interventions

arm Group Labels
A
B
C
D
name
Adriamycin
type
DRUG
arm Group Labels
A
B
C
D
name
Bleomycin
type
DRUG
arm Group Labels
A
B
name
Vinblastine
type
DRUG
arm Group Labels
A
B
name
DTIC
type
DRUG
arm Group Labels
C
D
name
Etoposide
type
DRUG
arm Group Labels
C
D
name
Procarbazine
type
DRUG
arm Group Labels
C
D
name
Prednisone
type
DRUG
arm Group Labels
C
D
name
Vincristine
type
DRUG
arm Group Labels
A
B
C
D
description
20 or 30Gy IF-RT
name
radiation therapy
type
RADIATION

Study design

allocation

RANDOMIZED

intervention Model

FACTORIAL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 1395
type: ACTUAL

Registered outcome plans (not posted results)

Full study description

brief Summary: 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.

Source references

references

citation
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.
pmid
20713848
type
RESULT
citation
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.
pmid
24121121
type
DERIVED
citation
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.
pmid
23509310
type
DERIVED