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HD16

  • Early stages

Trial-related material

Purpose / objectives

The objective of the HD16 trial is to further individualize treatment for patients with early stage Hodgkin lymphoma. For this purpose an FDG-PET examination is performed after two cycles of ABVD. In the standard arm, all patients receive a subsequent radiotherapy. In the experimental arm, it depends on the individual treatment response whether a patient is further treated with radiotherapy or not. Only patients who show an inadequate treatment response are irradiated after chemotherapy. Patients with a good response do not receive radiotherapy. This procedure aims to reduce the toxicity of treatment without impairing treatment results. Further objectives of this trial are to compare progression-free survival (PFS) in both arms, to evidence that chemotherapy alone is not inferior in terms of PFS compared to a combined chemo- and radiotherapy, and to verify that PET is a valid means to identify a certain risk group. Other endpoints included in the analysis are overall survival (OS), late toxicities and secondary malignancies.

Patient attributes

Stage CS (PS)

  • IA (except for LPHD), IB, IIA, IIB without one of the following risk factors:
  • Large mediastinal mass (? one third of the maximum transverse thorax diameter); extranodal involvement; high ESR (? 50 mm/h in case of present A symptoms, ? 30 mm/h in case of present B symptoms); 3 or more involved lymph node areas

Age

  • 18-75

Crucial inclusion criteria

  • Histologically confirmed primary diagnosis of Hodgkin lymphoma
  • Patient has not received any previous treatment for HL
  • Age 18-75
  • Patient has given their written informed consent to participate in the trial
  • Normal organ function (except HL-related)

Crucial exclusion criteria

  • Prior or concurrent disease that prevents treatment according to protocol
  • Hodgkin lymphoma as composite lymphoma
  • Malignant disease within the last 5 years (see trial protocol for exceptions)
  • Pregnancy, lactation
  • Non-compliance
  • Participation in another interventional trial that might interact with this trial

Study design

  • Phase III, multicenter, randomized

Therapeutic intervention

Standard arm

  • 2 x ABVD + 20 Gy IF-RT

Experimental arm

  • 2 x ABVD for all patients, subsequent stratification by means of FDG-PET
  • For PET-positive patients: + 20 Gy IF-RT
  • For PET-negative patients: end of treatment

After inclusion into the trial, patients are randomized to either the standard arm or the experimental arm. The trial is blinded in the beginning, i.e. the treating physician will not be informed which trial arm their patient was allocated to. Treatment allocation will only be unblinded after two more cycles of ABVD chemotherapy and a subsequent FDG-PET examination.

Patients in the standard arm receive radiotherapy independent of their FDG-PET result. Patients in the experimental arm with a positive FDG-PET result also receive radiotherapy. Patients with a negative PET result, however, do not receive radiotherapy. This concept aims to minimize treatment-related toxicity while maintaining treatment efficacy.

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