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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
518
Total dose 20 Gy Involved site radiotherapy
Total dose 30 Gy Involved site radiotherapy
A.O.U. SS. Antonio e Biagio e C. Arrigo - S.C.D.U. Ematologia
Alessandria, Italy
NOT_YET_RECRUITINGA.O.R.N. G Moscati - U.O.C. Ematologia e Terapie cellulari avanzate
Avellino, Italy
NOT_YET_RECRUITINGIRCCS Centro Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati
Aviano, Italy
NOT_YET_RECRUITINGASST Papa Giovanni XXIII - S.C. Ematologia
Bergamo, Italy
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).
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)
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)
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)
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)
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).
Time frame: At time of radiotherapy (about 4 months from chemotherapy start)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinica Humanitas Gavazzeni - U.O. Oncologia Medica
Bergamo, Italy
NOT_YET_RECRUITINGASST Spedali Civili - S.C. Ematologia
Brescia, Italy
NOT_YET_RECRUITINGARNAS "Brotzu" P.O. Businco - S.C. Ematologia e TMO
Cagliari, Italy
NOT_YET_RECRUITINGI.R.C.C.S. Istituto di Candiolo - FPO
Candiolo, Italy
NOT_YET_RECRUITINGARNAS Garibaldi - U.O.C. Ematologia
Catania, Italy
NOT_YET_RECRUITINGA.O. S. Croce e Carle - S.C. Ematologia
Cuneo, Italy
NOT_YET_RECRUITING...and 28 more locations