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

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ClinicalTrials.gov Identifier: NCT03829033
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Lund University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Tonsil Cancer Radiation: Radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
Actual Study Start Date : January 22, 2019
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : January 2028

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.




Primary Outcome Measures :
  1. Acute side effects. [ 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

  2. Late side effects. [ 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829033


Contacts
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Contact: Maria Gebre-Medhin, MD +46 46 17 75 20 maria.gebre-medhin@skane.se
Contact: Iréne Schönström, RN +46 46 17 85 59 irene.schonstrom@skane.se

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

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Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT03829033     History of Changes
Other Study ID Numbers: Version 2 2018-10-10
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lund University Hospital:
Tonsil Cancer
Early Tonsil Cancer
Radiotherapy
Photons
Protons
Acute Side Effects
Late Side Effects
Locoregional Control
Disease Free Survival
Quality of Life
Health Economic
Additional relevant MeSH terms:
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Tonsillar Neoplasms
Oropharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases