REPROton-HN: Prospective Observational Study on Proton Re-irradiation for Locoregional Recurrences of Head and Neck Tumors (REPROton-HN)
Some patients with head and neck cancer may develop a tumor recurrence in an area that has already been treated with radiotherapy. In these situations, surgery is not always possible, and giving radiotherapy again can be challenging because nearby healthy tissues and organs may already have received high radiation doses.
The REPROton-HN study is evaluating the use of proton therapy for these patients. Proton therapy is a type of radiation treatment that can deliver radiation more precisely to the tumor while reducing exposure to surrounding healthy tissues.
The aim of the study is to better understand how safe and effective proton therapy is when used as a second course of radiation treatment. Researchers will monitor side effects, tumor control, survival, and patients' quality of life. The results may help improve treatment planning and identify which patients are most likely to benefit from proton therapy in the future.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Laura Bonavita, Master degree
- Telefonnummer: +39 0282247026
- E-post: laura.bonavita@humanitas.it
Studera Kontakt Backup
- Namn: Maria Ausilia Teriaca, MD, radiation oncologist
- Telefonnummer: +39 0282247461
- E-post: maria.ausilia.teriaca@cancercenter.humanitas.it
Studieorter
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Milano
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Rozzano, Milano, Italien, 20089
- Rekrytering
- Irccs Humanitas Research Hospital
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Kontakt:
- Laura Bonavita, Master degree
- Telefonnummer: +39 0282247026
- E-post: laura.bonavita@humanitas.it
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Kontakt:
- Barbara Alt, nurse
- Telefonnummer: +39 0282248513
- E-post: barbara.alt@humanitas.it
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- ≥ 18 years old
- ECOG 0-2
- Pathologically and or radiologically confirmed head and neck cancer recurrence
- Indication for proton therapy
- Written informed consent for REPRO-HN according to applicable legal and ethical requirements by the end of radiotherapy treatment
Exclusion Criteria:
- Age < 18 years old
- ECOG>3
- Life expectancy < 3 months
- Inability to provide informed consent
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
Re-irradiation with proton
treatment of recurrence of tumor with protontherapy
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluation of toxicities profiles
Tidsram: from enrollment to 5 years follow up
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To Evaluate Short and Long-Term Toxicity Profiles - Assess acute and late-onset side effects and compare toxicity rates with conventional radiotherapy.
Adverse event will be evaluated through CTCAE V.5.0 classification
|
from enrollment to 5 years follow up
|
|
Number of partecipants with disease free survival
Tidsram: from enrollment to 5 years follow up
|
assessment of the number of patients with no disease progression at follow-ups.
Assessed by conventional imaging (PET, RMI, CT)
|
from enrollment to 5 years follow up
|
|
number of patients with Loco-regional control
Tidsram: from enrollment to 5 years follow up
|
assessment of the number of patients with no loco-regional disease progression at follow-ups.
Assessed by conventional imaging (PET, RMI, CT)
|
from enrollment to 5 years follow up
|
|
number of patient with distant metastasis free survival
Tidsram: from enrollment to 5 years follow up
|
Assessment of the number of patients with no distant metastasis at follow-ups.
Assessed by conventional imaging (PET, RMI, CT)
|
from enrollment to 5 years follow up
|
|
Quality of life outcomes
Tidsram: from enrollment to 5 years follow up
|
evaluation of quality of life of patients through the completion of questionnarie QLQ-C30.
Question with a scale from 1 to 4 (1 low quality of life - 4 high quality of life)
|
from enrollment to 5 years follow up
|
|
assessment of treatment response
Tidsram: from enrollment to 5 years follow up
|
assessment of the pathology's response to treatment by imaging
|
from enrollment to 5 years follow up
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Maria Ausilia Teriaca, MD, radiation oncologist, Humanitas Research Hospital IRCCS, Rozzano-Milan
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PRO/OSS - 003/2026
Läkemedels- och apparatinformation, studiedokument
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