NCT00265018 · CITED IN SOURCE DOCUMENTS

HD10 for Early 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: 2011-07-29

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.

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,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
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

intervention Names
Drug: Adriamycin
Drug: Bleomycin
Drug: Vinblastine
Drug: DTIC
Radiation: 30 Gy IF-RT
label
Arm A
type
ACTIVE_COMPARATOR
intervention Names
Drug: Adriamycin
Drug: Bleomycin
Drug: Vinblastine
Drug: DTIC
Radiation: 20 Gy IF-RT
label
Arm B
type
EXPERIMENTAL
intervention Names
Drug: Adriamycin
Drug: Bleomycin
Drug: Vinblastine
Drug: DTIC
Radiation: 30 Gy IF-RT
label
Arm C
type
EXPERIMENTAL
intervention Names
Drug: Adriamycin
Drug: Bleomycin
Drug: Vinblastine
Drug: DTIC
Radiation: 20 Gy IF-RT
label
Arm D
type
EXPERIMENTAL

interventions

arm Group Labels
Arm A
Arm B
Arm C
Arm D
name
Adriamycin
type
DRUG
arm Group Labels
Arm A
Arm B
Arm C
Arm D
name
Bleomycin
type
DRUG
arm Group Labels
Arm A
Arm B
Arm C
Arm D
name
Vinblastine
type
DRUG
arm Group Labels
Arm A
Arm B
Arm C
Arm D
name
DTIC
type
DRUG
arm Group Labels
Arm A
Arm C
name
30 Gy IF-RT
type
RADIATION
arm Group Labels
Arm B
Arm D
name
20 Gy IF-RT
type
RADIATION

Study design

allocation

RANDOMIZED

intervention Model

FACTORIAL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 1370
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Progression free survival (PFS)
time Frame
5 years

Full study description

brief Summary: 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.

Source references

references

citation
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.
pmid
20818855
type
RESULT
citation
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.
pmid
29989855
type
DERIVED
citation
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.
pmid
26834240
type
DERIVED
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