Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.

Last updated: August 31, 2021
Sponsor: Lund University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03829033
Version 2 2018-10-10
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The patient must be at least 18 years old.
  2. Histologically or cytologically confirmed, previously untreated squamous cellcarcinoma 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 forunimodal and ipsilateral treatment with radiotherapy with curative intent. Thetreatment may be followed but not preceded by surgery, which would be as a salvageprocedure and not part of the planned treatment. An excision of a lymph node, or atonsillectomy for diagnostic purposes does not exclude the patient from participation.
  3. World Health Organisation/Eastern Cooperative Oncology Group (WHO/ECOG) performancestatus 0-1.
  4. The patient must be able to understand the information about the treatment and give awritten informed consent.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 100
Study Start date:
January 22, 2019
Estimated Completion Date:
January 31, 2028

Connect with a study center

  • Gävle Hospital

    Gävle, SE-803 24
    Sweden

    Active - Recruiting

  • Sahlgrenska University Hospital

    Göteborg, SE-413 46
    Sweden

    Active - Recruiting

  • Jönköping Hospital

    Jönköping, SE-553 05
    Sweden

    Active - Recruiting

  • Karlstad Hospital

    Karlstad, SE-652 30
    Sweden

    Active - Recruiting

  • Linköping University Hospital

    Linköping, SE-587 50
    Sweden

    Active - Recruiting

  • Lund University Hospital

    Lund, SE-221 85
    Sweden

    Active - Recruiting

  • Karolinska University Hospital

    Stockholm, SE-171 64
    Sweden

    Active - Recruiting

  • University Hospital

    Umeå, SE-907 37
    Sweden

    Active - Recruiting

  • Scandion clinic

    Uppsala, SE-752 37
    Sweden

    Active - Recruiting

  • Uppsala Accademical Hospital

    Uppsala, SE-753 09
    Sweden

    Active - Recruiting

  • Västmanlands Hospital

    Västerås, SE-723 35
    Sweden

    Active - Recruiting

  • Örebro University Hospital

    Örebro, SE-703 82
    Sweden

    Active - Recruiting

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