NCT00736320 · CITED IN SOURCE DOCUMENTS

HD16 for Early Stage Hodgkin Lymphoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: UNKNOWN
Registry last update: 2020-11-04

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: 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
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
2 cycles ABVD followed by 20 Gy IF-RT irrespective of FDG-PET results after chemotherapy
intervention Names
Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)
Radiation: 20 Gy IFRT (Involved Field Radiotherapy)
label
A
type
ACTIVE_COMPARATOR
description
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
intervention Names
Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)
Radiation: 20 Gy IFRT (Involved Field Radiotherapy)
label
B
type
EXPERIMENTAL

interventions

arm Group Labels
A
B
description
chemotherapy with 2 cycles of ABVD (day 1 + 15)
name
ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)
type
DRUG
arm Group Labels
A
B
description
20 Gy Involved Field Radiotherapy
name
20 Gy IFRT (Involved Field Radiotherapy)
type
RADIATION

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 1150
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Progression Free Survival
time Frame
5 years

secondary Outcomes

measure
overall survival
time Frame
5 years
measure
acute toxicity
time Frame
5 years
measure
late toxicity
time Frame
5 years
measure
CR rate
time Frame
5 years

Full study description

brief 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).

Source references

references

citation
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
type
DERIVED
citation
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
type
DERIVED
citation
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
type
DERIVED
citation
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
type
DERIVED
citation
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
type
DERIVED
citation
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
type
DERIVED