Head & Neck CancerREPROton-HNNCT07635641
REPROton-HN: Prospective Observational Study on Proton Re-irradiation for Locoregional Recurrences of Head and Neck Tumors
An observational study of Head & Neck Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head & Neck Cancer
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 29 May 2026to May 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with head and neck cancer who develop locoregional recurrence after prior radiotherapy and candidate to re-irradiation with proton therapy
Who may be able to join
- ≥ 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
Who cannot join
- Age < 18 years old
- ECOG>3
- Life expectancy < 3 months
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Ausilia Teriaca, MD, radiation oncologist contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Humanitas Research Hospital
Rozzano, Milano, 20089
Laura Bonavita, Master degree, +39 0282247026, laura.bonavita@humanitas.it
Barbara Alt, nurse, +39 0282248513, barbara.alt@humanitas.it
About this study
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.
- Conditions
- Head & Neck Cancer
- Keywords
- head&neck cancer, re-irradiation, proton-therapy, protontherapy, radiotherapy, cancer
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Re-irradiation with proton | treatment of recurrence of tumor with protontherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of toxicities profiles
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
Measured: from enrollment to 5 years follow up
Number of partecipants with disease free survival
assessment of the number of patients with no disease progression at follow-ups. Assessed by conventional imaging (PET, RMI, CT)
Measured: from enrollment to 5 years follow up
number of patients with Loco-regional control
assessment of the number of patients with no loco-regional disease progression at follow-ups. Assessed by conventional imaging (PET, RMI, CT)
Measured: from enrollment to 5 years follow up
number of patient with distant metastasis free survival
Assessment of the number of patients with no distant metastasis at follow-ups. Assessed by conventional imaging (PET, RMI, CT)
Measured: from enrollment to 5 years follow up
Quality of life outcomes
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)
Measured: from enrollment to 5 years follow up
assessment of treatment response
assessment of the pathology's response to treatment by imaging
Measured: from enrollment to 5 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start29 May 2026
- Primary completionJun 2031 (estimated)
- Study completionMay 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & Neck CancerStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Ausilia Teriaca, MD, radiation oncologist, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635641
- Sponsor's protocol ID
- PRO/OSS - 003/2026
- Acronym
- REPROton-HN
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REPROton-HN: Prospective Observational Study on Proton Re-irradiation for Locoregional Recurrences of Head and Neck Tumors
- ClinicalTrials.gov ID
- NCT07635641
- Acronym / sponsor ID
- REPROton-HN / PRO/OSS - 003/2026
- Conditions
- Head & Neck Cancer
- Keywords
- head&neck cancer, re-irradiation, proton-therapy, protontherapy, radiotherapy, cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 29 May 2026 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- May 2036 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Re-irradiation with proton | – | –treatment of recurrence of tumor with protontherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with head and neck cancer who develop locoregional recurrence after prior radiotherapy and candidate to re-irradiation with proton therapy
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (4 listed)
- Age < 18 years old
- ECOG>3
- Life expectancy < 3 months
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of toxicities profiles
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from enrollment to 5 years follow up
assessment of the pathology's response to treatment by imaging
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Related trials for Head & Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Ausilia Teriaca, MD, radiation oncologist contact
Maria Ausilia Teriaca, MD, radiation oncologist principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head & Neck Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Ausilia Teriaca, MD, radiation oncologist (+39 0282247461, maria.ausilia.teriaca@cancercenter.humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of toxicities profiles (time frame: from enrollment to 5 years follow up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.