PET Guided Dose Reduction for InvOlved Site Radiotherapy In Early sTage Unfavourable Hodgkin Lymphoma

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Italiana Linfomi - ETS

About this trial

The final analysis of GHSG HD11 study (not PET driven) showed that 30 Gy IFRT still remains the standard dose after 4 ABVD.

Early PET negativity might allow safe radiation de-escalation in patients achieving a metabolic complete response after 2 ABVD.

The aim of Priority trial is to explore whether radiotherapy could be safely deescalated to 20 Gy without loss of efficacy in patients treated with four cycles of ABVD who achieved complete metabolic response after the first two cycles.

Eligibility criteria

Qualifiers

Age ≥18 years;

Histologically confirmed classical HL stage I, II unfavorable according to GHSG criteria;

Patient with any nodal mass ≥ than 10 cm can be included

No previous treatment for Hodgkin lymphoma;

Disqualifiers

Stage II B- III- IV

Hodgkin Lymphoma as "composite lymphoma" or nodular lymphocyte prevalence histological subtype

Active HBV and HCV infection

HIV seropositivity

Trial design

Treatments tested in this trial

  • 20 Gy Involved site radiotherapy
  • 30 Gy Involved site radiotherapy

Treatment groups

518 Participants
are divided into 2 treatment groups