Head & Neck Cancer
Conditions
Keywords
head&neck cancer, re-irradiation, proton-therapy, protontherapy, radiotherapy, cancer
Brief summary
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.
Interventions
None listed
Sponsors
Istituto Clinico Humanitas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of toxicities profiles | from enrollment to 5 years follow up | 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 |
| Number of partecipants with disease free survival | 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) |
| number of patients with Loco-regional control | 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) |
| number of patient with distant metastasis free survival | 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) |
| Quality of life outcomes | 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) |
| assessment of treatment response | from enrollment to 5 years follow up | assessment of the pathology's response to treatment by imaging |
Countries
Italy
Contacts
CONTACTMaria Ausilia Teriaca, MD, radiation oncologist
CONTACTLaura Bonavita, Master degree
PRINCIPAL_INVESTIGATORMaria Ausilia Teriaca, MD, radiation oncologist
Humanitas Research Hospital IRCCS, Rozzano-Milan
Outcome results
None listed