drugset / Trial / NCT00264953
HD11 for Intermediate Stages
RandomizedFactorialOpen-labelTreatment
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.
Timeline
- Start
- 1998-05
- Primary completion
- 2003-01
- Completion
- —
Outcome
Mixed primary results
paper after four cycles of BEACOPP(baseline), 20 Gy was not inferior to 30 Gy PMID 20713848 ↗
paper whereas inferiority of 20 Gy cannot be excluded after four cycles of ABVD PMID 20713848 ↗
Publications
- Results 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dacarbazine | Small molecule | — | — |
| Subject | Etoposide | Small molecule | — | — |
| Subject | Prednisone | Other / unclassified | — | — |
| Subject | Vinblastine | Small molecule | — | — |
| Subject | Vincristine | Small molecule | — | — |
| Subject | procarbazine | Small molecule | — | — |
| Background | Bleomycin | Unknown | — | — |
| Background | Doxorubicin | Other / unclassified | — | — |