Radiotherapy
RadiationRadiotherapy with either photons or protons.
NCT Number: NCT03829033
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Sahlgrenska University Hospital, Gothenburg, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Radiotherapy with either photons or protons.
Time frame: From the third week of radiotherapy, and then weekly during radiotherapy, which ends after 7 weeks.
Locoregional side effects (mucositis, pain, dysphagia, skin reactions and other functional impairment) are monitored weekly according to a modified morbidity scoring scale based on Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC). Acute radiation morbidity scoring criteria and other side effects are graded according to (Common Toxicity Criteria for Adverse Events (CTCAE) v4.0
Time frame: At 2-3 months after completed radiotherapy, then every 3 month for 2 years, and then every 6 month until 5 years.
Locoregional side effects (mucositis, pain, dysphagia, skin reactions and other functional impairment) are monitored according to a modified morbidity scoring scale based on Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC). Late radiation morbidity scoring criteria and other side effects are graded according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.
Contact information is provided by the study sponsor or research team.
Iréne Schönström, RN
CONTACT
Maria Gebre-Medhin, MD
CONTACT
Lund University Hospital
Other
Acronym: ARTSCAN V
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06902623
Base of Tongue Cancer, HPV
Washington D.C., District of Columbia, United States
View Trial DetailsNCT06915038
Carcinoma, Carcinoma, Squamous Cell
Carmel, Indiana, United States
View Trial DetailsNCT04277858
Base of the Tongue Carcinoma, Head and Neck Neoplasms
Montreal, Quebec, Canada
View Trial DetailsNCT05696314
Base of Tongue Carcinoma, Base of the Tongue Tumor
Aarhus, Denmark
View Trial Details