Proton versus photon treatment for squamous cell cancers of the head and neck

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 is a national, randomized phase III trial comparing proton radiotherapy to conventional photon radiotherapy for curative-intent treatment of head and neck squamous cell carcinoma. Comparative dose plans using both modalities will be created and normal tissue complication probability (NTCP) models used to identify patients predicted to benefit from protons; those with presumed benefit will be randomized 1:1 to protons or photons. The study plans to randomize 400 participants and will include patients treated definitively or postoperatively, with or without concurrent cisplatin. The primary outcome is combined toxicity burden (dry mouth, difficulty swallowing, pain, and affected speech) measured from the end of radiotherapy to 12 months after treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed informed consent.
2. Age ≥ 40 years.
3. Histological or cytological verified squamous cell carcinoma of the following head and neck regions; oral cavity, oropharynx, hypopharynx or larynx.
4. Planned for standard radiotherapy with curative intent, either as definitive or postoperative treatment with or without concomitant chemotherapy (cisplatin).
5. ECOG performance status 0-2.
6. Ability to fill in patient questionnaires and comply with study procedures.
7. Able to answer questionnaires in Norwegian or English.
8. Willing to travel to Oslo or Bergen for proton therapy if randomised to experimental arm.

Exclusion Criteria:

1. Glottic cancers, cT1-T2 cN0 cM0.
2. Nasopharyngeal carcinomas, sino-nasal cancers, and head and neck salivary gland carcinomas.
3. Distant metastasis.
4. Previous radiotherapy to the head and neck.
5. Patients with pacemakers and/or implanted defibrillators.
6. Prior malignancy within the last 5 years. Not including radically resected non-melanoma skin cancer or low-risk early-stage prostate cancer.
7. Not able to participate due to equipment restrictions (weight limit treatment board 150 kg).
8. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could, at the investigator's opinion, interfere with the participant's safety or study participation.

Where it's running

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

Study contacts

• Principal investigator: Hanne Eide, MD PhD — Oslo University Hospital
• Study coordinator: Barbro Berggren, Cand.Scient
• Email: barbbe@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.