Clinical trial · Interventional
HD10 for Early Stages
NCT00265018CI-TRIAL-00005295completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 20 Gy IF-RT | Radiation | — | UNRESOLVED |
| 30 Gy IF-RT | Radiation | — | UNRESOLVED |
| Adriamycin | Drug | — | UNRESOLVED |
| Bleomycin | Drug | Bleomycin | ALIAS |
| DTIC | Drug | Dacarbazine | ALIAS |
| Vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- interventionNames
- Drug: Adriamycin
- Drug: Bleomycin
- Drug: Vinblastine
- Drug: DTIC
- Radiation: 30 Gy IF-RT
- type
- EXPERIMENTAL
- label
- Arm B
- interventionNames
- Drug: Adriamycin
- Drug: Bleomycin
- Drug: Vinblastine
- Drug: DTIC
- Radiation: 20 Gy IF-RT
- type
- EXPERIMENTAL
- label
- Arm C
- interventionNames
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,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
References
Publications (5)
- RESULTEngert 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
- DERIVEDSasse 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
- DERIVEDBoll 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
- 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.