REPROton-HN: Prospective Observational Study on Proton Re-irradiation for Locoregional Recurrences of Head and Neck Tumors (REPROton-HN)

June 3, 2026 updated by: Istituto Clinico Humanitas

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Milano
      • Rozzano, Milano, Italy, 20089

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with head and neck cancer who develop locoregional recurrence after prior radiotherapy and candidate to re-irradiation with proton therapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Re-irradiation with proton
treatment of recurrence of tumor with protontherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from enrollment to 5 years follow up
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)
from enrollment to 5 years follow up
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)
from enrollment to 5 years follow up
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)
from enrollment to 5 years follow up
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)
from enrollment to 5 years follow up
assessment of treatment response
Time Frame: from enrollment to 5 years follow up
assessment of the pathology's response to treatment by imaging
from enrollment to 5 years follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Investigators

  • Principal Investigator: Maria Ausilia Teriaca, MD, radiation oncologist, Humanitas Research Hospital IRCCS, Rozzano-Milan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2026

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

May 1, 2036

Study Registration Dates

First Submitted

June 3, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO/OSS - 003/2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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