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

Primary Purpose

Tonsil Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
Lund University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tonsil Cancer focused on measuring Tonsil Cancer, Early Tonsil Cancer, Radiotherapy, Photons, Protons, Acute Side Effects, Late Side Effects, Locoregional Control, Disease Free Survival, Quality of Life, Health Economic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gävle HospitalRecruiting
  • Sahlgrenska University HospitalRecruiting
  • Jönköping HospitalRecruiting
  • Karlstad HospitalRecruiting
  • Linköping University HospitalRecruiting
  • Lund University HospitalRecruiting
  • Karolinska University HospitalRecruiting
  • University HospitalRecruiting
  • Scandion clinicRecruiting
  • Uppsala Accademical HospitalRecruiting
  • Västmanlands HospitalRecruiting
  • Örebro University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Radiotherapy delivered with photons

Radiotherapy delivered with protons

Arm Description

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2019
Last Updated
August 31, 2021
Sponsor
Lund University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03829033
Brief Title
Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
Acronym
ARTSCAN V
Official Title
Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2019 (Actual)
Primary Completion Date
January 2028 (Anticipated)
Study Completion Date
January 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsil Cancer
Keywords
Tonsil Cancer, Early Tonsil Cancer, Radiotherapy, Photons, Protons, Acute Side Effects, Late Side Effects, Locoregional Control, Disease Free Survival, Quality of Life, Health Economic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy delivered with photons
Arm Type
Active Comparator
Arm Title
Radiotherapy delivered with protons
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Radiotherapy with either photons or protons.
Primary Outcome Measure Information:
Title
Acute side effects.
Description
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
From the third week of radiotherapy, and then weekly during radiotherapy, which ends after 7 weeks.
Title
Late side effects.
Description
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.
Time Frame
At 2-3 months after completed radiotherapy, then every 3 month for 2 years, and then every 6 month until 5 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient must be at least 18 years old. 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. World Health Organisation/Eastern Cooperative Oncology Group (WHO/ECOG) performance status 0-1. The patient must be able to understand the information about the treatment and give a written informed consent. Exclusion Criteria: Patients judged to benefit from bilateral radiotherapy or concomitant chemotherapy 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. Two or more synchronous primary cancers in the head and neck region at time of diagnosis Previous surgery or radiotherapy in the head and neck region that may affect the study result, as judged by the investigator Co-existing disease prejudicing survival (expected survival should be >2 years). Psychiatric or addictive disorders or other medical conditions which in the view of the investigator might impair patient compliance 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Gebre-Medhin, MD
Phone
+46 46 17 75 20
Email
maria.gebre-medhin@skane.se
First Name & Middle Initial & Last Name or Official Title & Degree
Iréne Schönström, RN
Phone
+46 46 17 85 59
Email
irene.schonstrom@skane.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Gebre-Medhin, MD
Organizational Affiliation
Lund University Hospiyal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gävle Hospital
City
Gävle
ZIP/Postal Code
SE-803 24
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann-Sofie Fransson, MD
Phone
+46 26 15 40 00
Email
ann-sofie.fransson@regiongavleborg.se
First Name & Middle Initial & Last Name & Degree
Ann-Sofie Fransson, MD
Facility Name
Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
SE-413 46
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hedda Haugen, MD
Phone
+46 31 343 60 42
Email
hedda.haugen@oncology.gu.se
First Name & Middle Initial & Last Name & Degree
Hedda Haugen, MD
Facility Name
Jönköping Hospital
City
Jönköping
ZIP/Postal Code
SE-553 05
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mattias Olin, MD
Phone
+46 10 24 25 942
Email
mattias.olin@rjl.se
First Name & Middle Initial & Last Name & Degree
Mattias Olin, MD
Facility Name
Karlstad Hospital
City
Karlstad
ZIP/Postal Code
SE-652 30
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Britta Lödén, MD
Phone
+46 54 61 50 00
Email
britta.loden@regionvarmland.se
First Name & Middle Initial & Last Name & Degree
Britta Lödén, MD
Facility Name
Linköping University Hospital
City
Linköping
ZIP/Postal Code
SE-587 50
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Flejmer, MD
Phone
+46 10 103 00 00
Email
anna.maria.flejmer@regionostergotland.se
First Name & Middle Initial & Last Name & Degree
Anna Flejmer, MD
Facility Name
Lund University Hospital
City
Lund
ZIP/Postal Code
SE-221 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Gebre-Medhin, MD
Phone
+46 46 17 75 20
Email
maria.gebre-medhin@skane.se
First Name & Middle Initial & Last Name & Degree
Maria Gebre-Medhin, MD
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
SE-171 64
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Gubanski, MD
Phone
+46 8 517 700 00
Email
michael.gubanski@sll.se
First Name & Middle Initial & Last Name & Degree
Michael Gubanski, MD
Facility Name
University Hospital
City
Umeå
ZIP/Postal Code
SE-907 37
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Björn Zackrisson, MD
Phone
+46 90 785 00 00
Email
bjorn.zackrisson@onkologi.umu.se
First Name & Middle Initial & Last Name & Degree
Björn Zackrisson, MD
Facility Name
Scandion clinic
City
Uppsala
ZIP/Postal Code
SE-752 37
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna Färlin, MD
Phone
+46 18 495 80 00
Email
johanna.farlin@skandion.se
First Name & Middle Initial & Last Name & Degree
Johanna Färlin, MD
Facility Name
Uppsala Accademical Hospital
City
Uppsala
ZIP/Postal Code
SE-753 09
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zahra Taheri Kadkhoda, MD
Phone
+46 18 611 00 00
Email
zahra.taheri.kadkhoda@akademiska.se
First Name & Middle Initial & Last Name & Degree
Zahra Taheri Kadkhoda, MD
Facility Name
Västmanlands Hospital
City
Västerås
ZIP/Postal Code
SE-723 35
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zizana Lovasova, MD
Phone
+46 21 17 39 04
Email
zuzana.lovasova@regionvastmanland.se
First Name & Middle Initial & Last Name & Degree
Zuzana Lovasova, MD
Facility Name
Örebro University Hospital
City
Örebro
ZIP/Postal Code
SE-703 82
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Lundin, MD
Phone
+46 19 602 10 00
Email
erik.lundin@regionorebrolan.se
First Name & Middle Initial & Last Name & Degree
Erik Lundin, MD

12. IPD Sharing Statement

Learn more about this trial

Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.

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