HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET
| Registry | NCT00736320, acronym HD16 |
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| Status | Unknown |
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| Phase | Phase 3 |
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| Study type | Interventional; randomized, parallel, masking: none, treatment |
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| Enrollment | 1150 (Actual) |
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| Sponsor | University of Cologne (Other) |
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| Conditions | Hodgkin Lymphoma |
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| Interventions | ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine), 20 Gy IFRT (Involved Field Radiotherapy) (Drug, radiation) |
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| Dates | start 2009-11-01, primary completion 2018-09-01, completion 2021-12-01 (estimated), first posted 2008-08-15, last updated 2020-11-04 |
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| Locations | 1 site in Germany |
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Related Papers Related Patents Related Grants Related Experts
All trials for Hodgkin Lymphoma All trials of ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine) All trials of 20 Gy IFRT (Involved Field Radiotherapy)
-Summary
This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS).
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| A | Active comparator | Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine); Radiation: 20 Gy IFRT (Involved Field Radiotherapy) | 2 cycles ABVD followed by 20 Gy IF-RT irrespective of FDG-PET results after chemotherapy |
| B | Experimental | Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine); Radiation: 20 Gy IFRT (Involved Field Radiotherapy) | 2 cycles ABVD followed by 20 Gy IF-RT if FDG-PET is positive after chemotherapy; 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy |
- ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine) (Drug): chemotherapy with 2 cycles of ABVD (day 1 + 15)
- 20 Gy IFRT (Involved Field Radiotherapy) (Radiation): 20 Gy Involved Field Radiotherapy
+Outcome measures
Primary outcomes
- Progression Free Survival [5 years]
Secondary outcomes
- overall survival [5 years]
- acute toxicity [5 years]
- late toxicity [5 years]
- CR rate [5 years]
+Eligibility
Sex: All, ages: 18 Years to 75 Years
Inclusion Criteria:
* Hodgkin Lymphoma
* CS I, II without risk factors
* large mediastinal mass (> 1/3 of maximum transverse thorax diameter)
* extranodal involvement
* elevated ESR
* 3 or more involved nodal areas
* Written informed consent
Exclusion Criteria:
* Leucocytes < 3000/µl
* Platelets < 100000/µl
* Hodgkin Lymphoma as composite lymphoma
* Activity index (WHO) > 2
+Locations (1)
| Facility | City | Country | Status |
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| 1st Dept. of Medicine, Cologne University Hospital | Cologne | Germany | |
+Publications
- Results publication: Lommen M, Weindler JJ, Jablonski J, Rosenbrock J, Borchmann P, Behringer K, Roth KS, Ufton D, Dietlein M, Kobe C, Ferdinandus J. Association between metabolic tumor burden and health-related quality of life in patients with classic Hodgkin lymphoma. Eur J Nucl Med Mol Imaging. 2026 Feb;53(3):1847-1855. doi: 10.1007/s00259-025-07569-5. Epub 2025 Oct 11. PMID 41074963
- Results publication: Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3. PMID 40135712
- Results publication: van Heek L, Stuka C, Kaul H, Muller H, Mettler J, Hitz F, Baues C, Fuchs M, Borchmann P, Engert A, Dietlein M, Voltin CA, Kobe C. Predictive value of baseline metabolic tumor volume in early-stage favorable Hodgkin Lymphoma - Data from the prospective, multicenter phase III HD16 trial. BMC Cancer. 2022 Jun 18;22(1):672. doi: 10.1186/s12885-022-09758-z. PMID 35717166
- Results publication: Fuchs M, Goergen H, Kobe C, Kuhnert G, Lohri A, Greil R, Sasse S, Topp MS, Schafer E, Hertenstein B, Soekler M, Vogelhuber M, Zijlstra JM, Keller UB, Krause SW, Wilhelm M, Maschmeyer G, Thiemer J, Duhrsen U, Meissner J, Viardot A, Eich H, Baues C, Diehl V, Rosenwald A, von Tresckow B, Dietlein M, Borchmann P, Engert A. Positron Emission Tomography-Guided Treatment in Early-Stage Favorable Hodgkin Lymphoma: Final Results of the International, Randomized Phase III HD16 Trial by the German Hodgkin Study Group. J Clin Oncol. 2019 Nov 1;37(31):2835-2845. doi: 10.1200/JCO.19.00964. Epub 2019 Sep 10. PMID 31498753
- Results publication: Voltin CA, Goergen H, Baues C, Fuchs M, Mettler J, Kreissl S, Oertl J, Klaeser B, Moccia A, Drzezga A, Engert A, Borchmann P, Dietlein M, Kobe C. Value of bone marrow biopsy in Hodgkin lymphoma patients staged by FDG PET: results from the German Hodgkin Study Group trials HD16, HD17, and HD18. Ann Oncol. 2018 Sep 1;29(9):1926-1931. doi: 10.1093/annonc/mdy250. PMID 30010775
- Results publication: Narang AK, Terezakis SA. Contemporary radiation therapy in combined modality therapy for Hodgkin lymphoma. J Natl Compr Canc Netw. 2015 May;13(5):597-605. doi: 10.6004/jnccn.2015.0077. PMID 25964643
+Investigators