Health TrialsbyHealthPanel

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

ConditionHodgkin Lymphoma
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

518 Participants
are divided into 2 treatment groups
Group A: Experimental arm - 20 Gy RadiotherapyExperimental treatment 1 intervention
Group B: Comparator arm - 30 Gy RadiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Progression-Free Survival (PFS) of the randomized population. Subjects with incomplete follow-up or with no disease evaluation will be censored at the date of last available documented status of freedom from failure.

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).

Secondary outcomes

1

To compare OS rates between de-escalated ISRT dose (20 Gy) and conventional ISRT dose (30 Gy) in patients with newly diagnosed early-stage unfavourable HL achieving a complete metabolic response (DS 1-3) after 2 ABVD cycles;

Overall Survival (OS) for the randomized population

Time frame
From the time of randomization to death from any cause (up to 82 months)
2

To evaluate PFS for the whole population

Progression free survival for the whole enrolled population

Time frame
From the date of consent to documented relapse, progression or death from any cause (up to 84 months)
3

To evaluate OS for the whole population

Overall Survival (OS) for the whole population

Time frame
From the date of consent to death from any cause (up to 84 months)
4

To describe pattern of failure "in field", "marginal field", "out of field" relapse after conventional and reduced ISRT;

Incidence and severity of Adverse Events, graded according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE v 5.0) during the treatment

Time frame
From the date of consent to death from any cause (up to 84 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Italiana Linfomi - ETS

Lead sponsor

Source ClinicalTrials.gov
Apply now