Clinical trial · Interventional

HD12 for Advanced Stages

NCT00265031CI-TRIAL-00007252completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

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 (8)

Intervention	Type	Mapped drug	Match
Adriamycin	Drug	—	UNRESOLVED
Bleomycin	Drug	Bleomycin	ALIAS
Cyclophosphamide	Drug	Cyclophosphamide	ALIAS
Etoposide	Drug	Etoposide	ALIAS
Prednisone	Drug	Prednisone	ALIAS
Procarbazine	Drug	Procarbazine	ALIAS
radiation therapy	Procedure	—	UNRESOLVED
Vincristine	Drug	Vincristine	ALIAS

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 16 Years
Maximum age: 65 Years

Show eligibility criteria text

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

References

Publications (2)

RESULTBorchmann 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. PMID 21990399
DERIVEDvon 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. PMID 30290903