Photon Therapy Versus Proton Therapy in Early Tonsil Cancer. (ARTSCAN V)

  • STATUS
    Recruiting
  • End date
    Jan 9, 2028
  • participants needed
    100
  • sponsor
    Lund University Hospital
Updated on 28 February 2022

Summary

In this trial, patients with early squamous cell carcinoma of the tonsil with clinical stage T1-2 (p16-positive or p16-negative) N0-1 (p16-positive)/N0-N2b (p16-negative) according to American Joint Committee on Cancer (AJCC) 8th edition, aimed for unimodal and ipsilateral treatment with radiotherapy with curative intent will be included. The patients will be randomized to in a 1:1 ratio to receive radiotherapy with either photons (conventional radiotherapy) versus radiotherapy with protons.

Details
Condition Tonsil Cancer
Treatment Radiotherapy
Clinical Study IdentifierNCT03829033
SponsorLund University Hospital
Last Modified on28 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The patient must be at least 18 years old
Histologically or cytologically confirmed, previously untreated squamous cell carcinoma of the tonsil T1-2 (p16-positive or p16-negative) N0-1 M0 (p16-positive)/N0-N2b M0 (p16-negative) according to AJCC 8th edition, aimed for unimodal and ipsilateral treatment with radiotherapy with curative intent. The treatment may be followed but not preceded by surgery, which would be as a salvage procedure and not part of the planned treatment. An excision of a lymph node, or a tonsillectomy for diagnostic purposes does not exclude the patient from participation
World Health Organisation/Eastern Cooperative Oncology Group (WHO/ECOG) performance status 0-1
The patient must be able to understand the information about the treatment and give a written informed consent

Exclusion Criteria

Patients judged to benefit from bilateral radiotherapy or concomitant chemotherapy
Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri with a follow-up time of at least 3 years, or other previous malignancy with a disease-free interval of at least 5 years
Two or more synchronous primary cancers in the head and neck region at time of diagnosis
Previous surgery or radiotherapy in the head and neck region that may affect the study result, as judged by the investigator
Co-existing disease prejudicing survival (expected survival should be >2 years)
Psychiatric or addictive disorders or other medical conditions which in the view of the investigator might impair patient compliance
When dental fillings with amalgam or metal are present close to the tumour area it must be considered if this may affect radiotherapy before inclusion
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