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

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT07256158
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 20 Gy Involved site radiotherapy — RADIATION
    Total dose 20 Gy Involved site radiotherapy
  • 30 Gy Involved site radiotherapy — RADIATION
    Total dose 30 Gy Involved site radiotherapy

Study Details

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.

Key Dates

First listed
Dec 1, 2025
Start date
Jul 10, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2029
Completion
Aug 31, 2033

Study Design

Enrollment
518 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental arm - 20 Gy Radiotherapy
    Involved site radiotherapy (ISRT) Total dose of 20 Gy is administered in 10 daily fractions of 2.0 Gy, five times a week over 2 weeks
  • Active Comparator: Comparator arm - 30 Gy Radiotherapy
    Involved site radiotherapy (ISRT) Total dose of 30 Gy is administered in 15 daily fractions of 2.0 Gy, five times a week over 3 weeks

Primary Outcome Measure

To evaluate if de-escalated ISRT dose (20 Gy) is not inferior to conventional ISRT dose (30 Gy) in terms of PFS in patients with newly diagnosed early-stage unfavourable HL achieving a complete metabolic response (DS 1-3) after 2 ABVD cycle [ Time Frame: From the date of randomization to documented relapse, progression or to the patient's death as a result of any causes (up to 82 months). ]

Central Contacts

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