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

December 2, 2025 updated by: Fondazione Italiana Linfomi - ETS

PET Guided Dose Reduction for InvOlved Site Radiotherapy In Early sTage Unfavourable Hodgkin Lymphoma: a Randomized, Phase III, Non-inferiority studY (PRIORITY Study)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

518

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Alessandria, Italy
        • A.O.U. SS. Antonio e Biagio e C. Arrigo - S.C.D.U. Ematologia
        • Contact:
        • Principal Investigator:
          • Manuela Zanni, MD
      • Avellino, Italy
        • A.O.R.N. G Moscati - U.O.C. Ematologia e Terapie cellulari avanzate
        • Principal Investigator:
          • Sonya De Lorenzo, MD
        • Contact:
      • Aviano, Italy
        • IRCCS Centro Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati
        • Contact:
        • Principal Investigator:
          • Michele Spina, MD
      • Bergamo, Italy
        • ASST Papa Giovanni XXIII - S.C. Ematologia
        • Contact:
        • Principal Investigator:
          • Silvia Ferrari, MD
      • Bergamo, Italy
        • Clinica Humanitas Gavazzeni - U.O. Oncologia Medica
        • Contact:
        • Principal Investigator:
          • Daniele Laszlo, MD
      • Brescia, Italy
      • Cagliari, Italy
        • ARNAS "Brotzu" P.O. Businco - S.C. Ematologia e TMO
        • Contact:
        • Principal Investigator:
          • Valeria Oggianu, MD
      • Candiolo, Italy
        • I.R.C.C.S. Istituto di Candiolo - FPO
        • Contact:
        • Principal Investigator:
          • Umberto Vitolo, MD
      • Catania, Italy
        • ARNAS Garibaldi - U.O.C. Ematologia
        • Principal Investigator:
          • Ugo Consoli, MD
        • Contact:
      • Cuneo, Italy
        • A.O. S. Croce e Carle - S.C. Ematologia
        • Principal Investigator:
          • Roberto Sorasio, MD
        • Contact:
      • Florence, Italy
      • Florence, Italy
        • Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
        • Contact:
        • Principal Investigator:
          • Benedetta Puccini, MD
      • Genova, Italy
        • IRCCS Policlinico S. Martino - U.O. Ematologia e terapie cellulari
        • Contact:
        • Principal Investigator:
          • Chiara Ghiggi, MD
      • Latina, Italy
        • ASL Latina Ospedale S. Maria Goretti - UOC Ematologia con trapianto
        • Contact:
        • Principal Investigator:
          • Natalia Cenfra, MD
      • Milan, Italy
      • Milan, Italy
        • IRCCS Fondazione Istituto Nazionale Tumori - S.C. Ematologia
        • Principal Investigator:
          • Paolo Corradini, MD
        • Contact:
      • Novara, Italy
      • Padua, Italy
      • Padua, Italy
        • I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1
        • Contact:
        • Principal Investigator:
          • Dario Marino, MD
      • Palermo, Italy
        • A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
        • Contact:
        • Principal Investigator:
          • Caterina Patti, MD
      • Pavia, Italy
        • IRCCS Fondazione Policlinico S. Matteo - S.C. Ematologia 1
        • Contact:
        • Principal Investigator:
          • Manuel Gotti, MD
      • Perugia, Italy
      • Piacenza, Italy
        • AUSL di Piacenza Ospedale Guglielmo da Saliceto - U.O.C. Ematologia e centro trapianti
        • Contact:
        • Principal Investigator:
          • Annalisa Arcari, MD
      • Ravenna, Italy
        • AUSL di Ravenna Osp. S. Maria delle Croci - U.O.C. Ematologia
        • Contact:
        • Principal Investigator:
          • Monica Tani, MD
      • Reggio Emilia, Italy
        • AUSL IRCCS Arcispedale S. Maria Nuova - S.C. Ematologia
        • Contact:
        • Principal Investigator:
          • Angela Ferrari, MD
      • Roma, Italy
        • A.O.U. Policlinico Umberto I - U.O.C Ematologia
        • Contact:
        • Principal Investigator:
          • Ilaria Del Giudice, MD
      • Roma, Italy
        • A.O.U. Sant'Andrea - U.O.C. Ematologia
        • Contact:
        • Principal Investigator:
          • Giacinto La Verde, MD
      • Roma, Italy
        • Fondazione Policlinico Campus Bio-Medico - U.O.C. Ematologia e trapianto di cellule staminali
        • Principal Investigator:
          • Luigi Rigacci, MD
        • Contact:
      • Rozzano, Italy
        • IRCCS Humanitas - U.O. Ematologia
        • Contact:
        • Principal Investigator:
          • Francesca Ricci, MD
      • San Giovanni Rotondo, Italy
        • IRCCS Fondazione Casa Sollievo della Sofferenza - UOC Ematologia e Trapianto di Cellule Staminali Ematopoietiche
        • Contact:
        • Principal Investigator:
          • Angelo Michele Carella, MD
      • Siena, Italy
        • A.O.U. Senese - U.O.C. Ematologia
        • Contact:
        • Principal Investigator:
          • Alberto Fabbri, MD
      • Terni, Italy
        • A.O. Santa Maria - S.C. Oncoematologia
        • Contact:
        • Principal Investigator:
          • Arcangelo Liso, MD
      • Torino, Italy
        • A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
        • Principal Investigator:
          • Barbara Botto, MD
        • Contact:
      • Torino, Italy
        • A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U
        • Contact:
        • Principal Investigator:
          • candida Vitale, MD
      • Treviso, Italy
      • Trieste, Italy
      • Udine, Italy
      • Verona, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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;
  • ECOG performance status 0 to 2;
  • Presence of FDG-avid lymphoma lesions on baseline PET scan;
  • Subject understands and voluntarily signs the informed consent form approved by the Independent Ethics Committee (IEC), prior to the initiation of any screening or study-specific procedures;

  • Adequate organ and marrow function as defined below:

    • absolute neutrophil count > 1.0 x109/L
    • platelet count > 75 x109/L
    • Total bilirubin < 2 mg/dl without a pattern consistent with Gilbert's syndrome
    • Aspartate Transaminase and Alanine Transaminase (AST/ALT) < 3.0 X institutional Upper Limits of Normality (ULN)
    • Creatinine within normal institutional limits or creatinine clearance > 50 mL/min
  • Women of childbearing potential must agree to use a highly effective method of contraception (oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device) from the signature of informed consent until six months after the last dose of treatment;
  • Men must agree to use a highly effective method of contraception (barrier contraception or abstinence, when this is in line with the usual lifestyle of the subject) from the signature of informed consent until six months after the last dose of treatment;
  • Women of childbearing potential must have a negative serum pregnancy test at screening.

Exclusion Criteria:

  • Patients who meet any of the following criteria are not eligible to enroll:
  • Stage II B- III- IV
  • Hodgkin Lymphoma as "composite lymphoma" or nodular lymphocyte prevalence histological subtype
  • Active HBV and HCV infection
  • HIV seropositivity
  • Pre-treatment with chemotherapy or radiation therapy
  • Malignant disease within the last 5 years (excluding basal skin tumors and carcinoma in situ of the cervix)
  • Women who are pregnant or breast feeding
  • Absence of FDG-avid lymphoma lesions on baseline PET scan
  • Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Radiation: 20 Gy Involved site radiotherapy
Total dose 20 Gy Involved site radiotherapy
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
Radiation: 30 Gy Involved site radiotherapy
Total dose 30 Gy Involved site radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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;
Time Frame: From the time of randomization to death from any cause (up to 82 months)
Overall Survival (OS) for the randomized population
From the time of randomization to death from any cause (up to 82 months)
To evaluate PFS for the whole population
Time Frame: From the date of consent to documented relapse, progression or death from any cause (up to 84 months)
Progression free survival for the whole enrolled population
From the date of consent to documented relapse, progression or death from any cause (up to 84 months)
To evaluate OS for the whole population
Time Frame: From the date of consent to death from any cause (up to 84 months)
Overall Survival (OS) for the whole population
From the date of consent to death from any cause (up to 84 months)
To describe pattern of failure "in field", "marginal field", "out of field" relapse after conventional and reduced ISRT;
Time Frame: From the date of consent to death from any cause (up to 84 months)
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
From the date of consent to death from any cause (up to 84 months)
To report details on RT treatment volumes and dose distributions and to estimate the dose received by the organs at risk (OARs) in the two treatment arms
Time Frame: At time of radiotherapy (about 4 months from chemotherapy start)
RT dose received by organs at risk (OARs).
At time of radiotherapy (about 4 months from chemotherapy start)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi - ETS

Investigators

  • Principal Investigator: Umberto Ricardi, MD, SC Radioterapia U - AOU Città della Salute e della Scienza di Torino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2033

Study Completion (Estimated)

March 1, 2033

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Estimated)

December 1, 2025

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_PRIORITY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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