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NCT Number: NCT07635641

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

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.

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Key information

Conditions

Head & Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. assessment of treatment response

    Time frame: from enrollment to 5 years follow up

    assessment of the pathology's response to treatment by imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Bonavita, Master degree

CONTACT

[email protected]

+39 0282247026

Maria Ausilia Teriaca, MD, radiation oncologist

CONTACT

[email protected]

+39 0282247461

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Acronym: REPROton-HN

Important dates

Study start
2026
Primary completion
2031
Study completion
2036
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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