Proton Re-irradiation for Recurrent or Second Primary Head and Neck Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, single-arm Phase II observational study will evaluate outcomes of hyperfractionated proton therapy for relapsed or second primary head and neck cancers after prior radiation. Participants are adults with histologically confirmed squamous cell carcinoma who are candidates for curative treatment and have loco-regional recurrence or a second primary at least six months after initial radiotherapy. The study will track survival, tolerability, and health-related quality of life and compare results with historical controls treated with hyperfractionated photons to guide future patient selection and treatment standards. A key goal is to help standardize treatment guidelines and follow-up nationwide.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Informed consent received
* Age ≥ 18 years
* Histological verified squamous cell carcinoma
* Candidate for treatment with curative intent
* Loco-regional recurrence or new second primary ≥ six months after primary radiotherapy
* Medical or surgical inoperable or without free margins ((R1: \< 1mm margin /R2: macroscopic residual tumour) or rpN2-3 or extranodal extension (ENE)) after surgical resection
* WHO PS ≤ 2
* Ability to understand and complete the study documents
* Complete Response (CR) after previous therapy, except in the case where the recurrence is considered a geometric miss (recurrence center of mass (COM) outside the 95% of prescription dose.

Exclusion Criteria:

* Distant metastasis
* Previous re-irradiation for overlapping second primary or relapse
* Severe late effects after primary radiotherapy (osteoradionecrosis, trismus grade 3 or dysphagia grade 3 before recurrence or second primary disease)
* Patients with pacemaker/ and/or implanted defibrillators.
* Comparative treatment planning showing an overall benefit of photon therapy compared to proton therapy

Where it's running

• Oslo University Hospital
  Oslo, Norway Recruiting
• Haukeland University Hospital
  Bergen, Norway Not yet recruiting
• University Hospital of North Norway
  Tromsø, Norway Not yet recruiting
• St.Olavs Hospital
  Trondheim, Norway Not yet recruiting

Study contacts

• Study coordinator: Cecilie Delphin Amdal, Principal Investigator
• Email: cecia@ous-hf.no
• Phone: 004722934000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.