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

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.

Study Overview

• Status: Recruiting
• Conditions: Tonsil Cancer
• Intervention / Treatment: Radiation: Radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Gebre-Medhin, MD; Phone Number: +46 46 17 75 20; Email: maria.gebre-medhin@skane.se
• Study Contact Backup: Name: Iréne Schönström, RN; Phone Number: +46 46 17 85 59; Email: irene.schonstrom@skane.se

Study Locations

• Sweden
  • Gävle, Sweden, SE-803 24
    • Recruiting
    • Gävle Hospital
    • Contact: Ann-Sofie Fransson, MD; Phone Number: +46 26 15 40 00; Email: ann-sofie.fransson@regiongavleborg.se
    • Principal Investigator: Ann-Sofie Fransson, MD
  • Göteborg, Sweden, SE-413 46
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Hedda Haugen, MD; Phone Number: +46 31 343 60 42; Email: hedda.haugen@oncology.gu.se
  • Jönköping, Sweden, SE-553 05
    • Recruiting
    • Jönköping Hospital
    • Contact: Mattias Olin, MD; Phone Number: +46 10 24 25 942; Email: mattias.olin@rjl.se
    • Principal Investigator: Mattias Olin, MD
  • Karlstad, Sweden, SE-652 30
    • Recruiting
    • Karlstad Hospital
    • Contact: Britta Lödén, MD; Phone Number: +46 54 61 50 00; Email: britta.loden@regionvarmland.se
    • Principal Investigator: Britta Lödén, MD
  • Linköping, Sweden, SE-587 50
    • Recruiting
    • Linkoping University Hospital
    • Contact: Anna Flejmer, MD; Phone Number: +46 10 103 00 00; Email: anna.maria.flejmer@regionostergotland.se
    • Principal Investigator: Anna Flejmer, MD
  • Lund, Sweden, SE-221 85
    • Recruiting
    • Lund University Hospital
    • Contact: Maria Gebre-Medhin, MD; Phone Number: +46 46 17 75 20; Email: maria.gebre-medhin@skane.se
    • Principal Investigator: Maria Gebre-Medhin, MD
  • Stockholm, Sweden, SE-171 64
    • Recruiting
    • Karolinska University Hospital
    • Contact: Michael Gubanski, MD; Phone Number: +46 8 517 700 00; Email: michael.gubanski@sll.se
    • Principal Investigator: Michael Gubanski, MD
  • Umeå, Sweden, SE-907 37
    • Recruiting
    • University Hospital
    • Contact: Björn Zackrisson, MD; Phone Number: +46 90 785 00 00; Email: bjorn.zackrisson@onkologi.umu.se
    • Principal Investigator: Björn Zackrisson, MD
  • Uppsala, Sweden, SE-752 37
    • Recruiting
    • Scandion clinic
    • Contact: Johanna Färlin, MD; Phone Number: +46 18 495 80 00; Email: johanna.farlin@skandion.se
    • Principal Investigator: Johanna Färlin, MD
  • Uppsala, Sweden, SE-753 09
    • Recruiting
    • Uppsala Accademical Hospital
    • Contact: Zahra Taheri Kadkhoda, MD; Phone Number: +46 18 611 00 00; Email: zahra.taheri.kadkhoda@akademiska.se
    • Principal Investigator: Zahra Taheri Kadkhoda, MD
  • Västerås, Sweden, SE-723 35
    • Recruiting
    • Västmanlands Hospital
    • Contact: Zizana Lovasova, MD; Phone Number: +46 21 17 39 04; Email: zuzana.lovasova@regionvastmanland.se
    • Principal Investigator: Zuzana Lovasova, MD
  • Örebro, Sweden, SE-703 82
    • Recruiting
    • Örebro University Hospital
    • Principal Investigator: Erik Lundin, MD
    • Contact: Erik Lundin, MD; Phone Number: +46 19 602 10 00; Email: erik.lundin@regionorebrolan.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The patient must be at least 18 years old.
2. 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.
3. World Health Organisation/Eastern Cooperative Oncology Group (WHO/ECOG) performance status 0-1.
4. The patient must be able to understand the information about the treatment and give a written informed consent.

Exclusion Criteria:

1. Patients judged to benefit from bilateral radiotherapy or concomitant chemotherapy
2. 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.
3. Two or more synchronous primary cancers in the head and neck region at time of diagnosis
4. Previous surgery or radiotherapy in the head and neck region that may affect the study result, 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 of the investigator might impair patient compliance
7. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Radiotherapy delivered with photons	Radiation: Radiotherapy; Radiotherapy with either photons or protons.
Experimental: Radiotherapy delivered with protons	Radiation: Radiotherapy; Radiotherapy with either photons or protons.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute side effects.	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	From the third week of radiotherapy, and then weekly during radiotherapy, which ends after 7 weeks.
Late side effects.	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.	At 2-3 months after completed radiotherapy, then every 3 month for 2 years, and then every 6 month until 5 years.

Collaborators and Investigators

• Sponsor: Lund University Hospital
• Investigators: Principal Investigator: Maria Gebre-Medhin, MD, Lund University Hospiyal

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2019
• Primary Completion (Anticipated): January 1, 2028
• Study Completion (Anticipated): January 1, 2028

Study Registration Dates

• First Submitted: February 1, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; Radiotherapy; Disease Free Survival; Tonsil Cancer; Early Tonsil Cancer; Photons; Protons; Acute Side Effects; Late Side Effects; Locoregional Control; Health Economic
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Oropharyngeal Neoplasms; Tonsillar Neoplasms
• Other Study ID Numbers: Version 2 2018-10-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No