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

NCT07635641 | Recruiting

• 1 other identifier: PRO/OSS - 003/2026
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Head & Neck Cancer

Keywords

head&neck cancer; re-irradiation; proton-therapy; protontherapy; radiotherapy; cancer

Outcome Measures

Primary Outcomes (6)

• 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

  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)

  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)

  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)

  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)

  from enrollment to 5 years follow up

• assessment of treatment response

  assessment of the pathology's response to treatment by imaging

  from enrollment to 5 years follow up

Study Arms (1)

Re-irradiation with proton

treatment of recurrence of tumor with protontherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• ≥ 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

You may not qualify if:

• Age \< 18 years old
• ECOG\>3
• Life expectancy \< 3 months
• Inability to provide informed consent

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

IRCCS Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site

Study Officials

• Maria Ausilia Teriaca, MD, radiation oncologist

  Humanitas Research Hospital IRCCS, Rozzano-Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Ausilia Teriaca, MD, radiation oncologist

CONTACT

+39 0282247461; maria.ausilia.teriaca@cancercenter.humanitas.it

Laura Bonavita, Master degree

CONTACT

+39 0282247026; laura.bonavita@humanitas.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): May 1, 2036
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

IT (1)