Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03829033

Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.

Led by Lund University Hospital · Updated on 2021-09-01

100

Participants Needed

12

Research Sites

466 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is at least 18 years old
  • Histologically or cytologically confirmed, untreated squamous cell carcinoma of the tonsil T1-2 (p16-positive or p16-negative) with specific nodal stages according to AJCC 8th edition
  • Treatment planned as unimodal, ipsilateral radiotherapy with curative intent
  • Surgery allowed only as salvage treatment after radiotherapy, not before or as part of planned treatment
  • WHO/ECOG performance status of 0 or 1
  • Ability to understand treatment information and provide written informed consent
Not Eligible

You will not qualify if you...

  • Patients needing bilateral radiotherapy or combined chemotherapy
  • Current or recent malignancies except certain treated skin cancers or cervical carcinoma with sufficient follow-up
  • Two or more synchronous primary head and neck cancers at diagnosis
  • Previous head and neck surgery or radiotherapy affecting study results
  • Co-existing diseases expected to limit survival to less than 2 years
  • Psychiatric, addictive, or medical conditions impairing compliance
  • Presence of metal dental fillings near tumor area that could affect radiotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

Gävle Hospital

Gävle, Sweden, SE-803 24

Actively Recruiting

2

Sahlgrenska University Hospital

Gothenburg, Sweden, SE-413 46

Actively Recruiting

3

Jönköping Hospital

Jönköping, Sweden, SE-553 05

Actively Recruiting

4

Karlstad Hospital

Karlstad, Sweden, SE-652 30

Actively Recruiting

5

Linköping University Hospital

Linköping, Sweden, SE-587 50

Actively Recruiting

6

Lund University Hospital

Lund, Sweden, SE-221 85

Actively Recruiting

7

Örebro University Hospital

Örebro, Sweden, SE-703 82

Actively Recruiting

8

Karolinska University Hospital

Stockholm, Sweden, SE-171 64

Actively Recruiting

9

University Hospital

Umeå, Sweden, SE-907 37

Actively Recruiting

10

Scandion clinic

Uppsala, Sweden, SE-752 37

Actively Recruiting

11

Uppsala Accademical Hospital

Uppsala, Sweden, SE-753 09

Actively Recruiting

12

Västmanlands Hospital

Västerås, Sweden, SE-723 35

Actively Recruiting

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Research Team

M

Maria Gebre-Medhin, MD

CONTACT

I

Iréne Schönström, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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