Clinical trial · Interventional

HD11 for Intermediate Stages

NCT00264953CI-TRIAL-00005322completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Hodgkin´s Lymphoma	—	UNRESOLVED	—

Interventions

Interventions (9)

Intervention	Type	Mapped drug	Match
Adriamycin	Drug	—	UNRESOLVED
Bleomycin	Drug	Bleomycin	ALIAS
DTIC	Drug	Dacarbazine	ALIAS
Etoposide	Drug	Etoposide	ALIAS
Prednisone	Drug	Prednisone	ALIAS
Procarbazine	Drug	Procarbazine	ALIAS
radiation therapy	Radiation	—	UNRESOLVED
Vinblastine	Drug	Vinblastine	ALIAS
Vincristine	Drug

Design

Arms and outcomes

Arms (4)

type
ACTIVE_COMPARATOR
label
A
description
4x ABVD plus 30Gy IF-RT
interventionNames
1. Drug: Adriamycin
2. Drug: Bleomycin
3. Drug: Vinblastine
4. Drug: DTIC
5. Radiation: radiation therapy
type
EXPERIMENTAL
label
C
description
4x BEACOPP baseline plus 30Gy IF-RT
interventionNames
1. Drug: Adriamycin
2. Drug: Bleomycin
3. Drug: Etoposide
4. Drug: Procarbazine
5. Drug: Prednisone
6. Drug: Vincristine
7. Radiation: radiation therapy

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 16 Years
Maximum age: 75 Years

Show eligibility criteria text

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

References

Publications (3)

RESULTEich 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
DERIVEDHay 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
DERIVEDBoll 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