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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm - 20 Gy Radiotherapy | Experimental | 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 |
|
| Comparator arm - 30 Gy Radiotherapy | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20 Gy Involved site radiotherapy | Radiation | Total dose 20 Gy Involved site radiotherapy |
|
| 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 | 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). |
| 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; | Overall Survival (OS) for the randomized population | From the time of randomization to death from any cause (up to 82 months) |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uffici Studi FIL | Contact | +390131033153 | startup@filinf.it | |
| Uffici Studi FIL | Contact | +390599769913 | gestionestudi@filinf.it |
| Name | Affiliation | Role |
|---|---|---|
| Umberto Ricardi, MD | SC Radioterapia U - AOU Città della Salute e della Scienza di Torino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O.U. SS. Antonio e Biagio e C. Arrigo - S.C.D.U. Ematologia | Alessandria | Italy |
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Randomized, Phase III, Non-inferiority study
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| 30 Gy Involved site radiotherapy | Radiation | Total dose 30 Gy Involved site radiotherapy |
|
| To evaluate PFS for the whole population | 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 | 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; | 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 | RT dose received by organs at risk (OARs). | At time of radiotherapy (about 4 months from chemotherapy start) |
| A.O.R.N. G Moscati - U.O.C. Ematologia e Terapie cellulari avanzate | Avellino | Italy |
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| IRCCS Centro Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati | Aviano | Italy |
|
| ASST Papa Giovanni XXIII - S.C. Ematologia | Bergamo | Italy |
|
| Clinica Humanitas Gavazzeni - U.O. Oncologia Medica | Bergamo | Italy |
|
| ASST Spedali Civili - S.C. Ematologia | Brescia | Italy |
|
| ARNAS "Brotzu" P.O. Businco - S.C. Ematologia e TMO | Cagliari | Italy |
|
| I.R.C.C.S. Istituto di Candiolo - FPO | Candiolo | Italy |
|
| ARNAS Garibaldi - U.O.C. Ematologia | Catania | Italy |
|
| A.O. S. Croce e Carle - S.C. Ematologia | Cuneo | Italy |
|
| A.S.L. Toscana Centro - SOC Oncoematologia | Florence | Italy |
|
| Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia | Florence | Italy |
|
| IRCCS Policlinico S. Martino - U.O. Ematologia e terapie cellulari | Genova | Italy |
|
| ASL Latina Ospedale S. Maria Goretti - UOC Ematologia con trapianto | Latina | Italy |
|
| ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia | Milan | Italy |
|
| IRCCS Fondazione Istituto Nazionale Tumori - S.C. Ematologia | Milan | Italy |
|
| A.O.U. Ospedale Maggiore della Carità - S.C.D.U. Ematologia | Novara | Italy |
|
| A.O.U. di Padova - U.O.C. Ematologia | Padova | Italy |
|
| I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1 | Padova | Italy |
|
| A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia | Palermo | Italy |
|
| IRCCS Fondazione Policlinico S. Matteo - S.C. Ematologia 1 | Pavia | Italy |
|
| A.O. Ospedale S. Maria della Misericordia - Ematologia | Perugia | Italy |
|
| AUSL di Piacenza Ospedale Guglielmo da Saliceto - U.O.C. Ematologia e centro trapianti | Piacenza | Italy |
|
| AUSL di Ravenna Osp. S. Maria delle Croci - U.O.C. Ematologia | Ravenna | Italy |
|
| AUSL IRCCS Arcispedale S. Maria Nuova - S.C. Ematologia | Reggio Emilia | Italy |
|
| A.O.U. Policlinico Umberto I - U.O.C Ematologia | Roma | Italy |
|
| A.O.U. Sant'Andrea - U.O.C. Ematologia | Roma | Italy |
|
| Fondazione Policlinico Campus Bio-Medico - U.O.C. Ematologia e trapianto di cellule staminali | Roma | Italy |
|
| IRCCS Humanitas - U.O. Ematologia | Rozzano | Italy |
|
| IRCCS Fondazione Casa Sollievo della Sofferenza - UOC Ematologia e Trapianto di Cellule Staminali Ematopoietiche | San Giovanni Rotondo | Italy |
|
| A.O.U. Senese - U.O.C. Ematologia | Siena | Italy |
|
| A.O. Santa Maria - S.C. Oncoematologia | Terni | Italy |
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| A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U | Torino | Italy |
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| A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia | Torino | Italy |
|
| ULSS 2 Ospedale Ca' Foncello - U.O.C. Ematologia | Treviso | Italy |
|
| A.S.U. Giuliano Isontina - S.C. Ematologia | Trieste | Italy |
|
| A.S.U. Friuli Centrale - Clinica Ematologica | Udine | Italy |
|
| A.O.U.I. di Verona - U.O.C. Ematologia | Verona | Italy |
|
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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