Back to resultsStudy on Proton Radiotherapy of Thymic Malignancies (PROTHYM)
Primary Purpose
Cardiotoxicity, Pulmonary Toxicity, Thymus Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Proton radiation
Sponsored by
About this trial
This is an interventional treatment trial for Cardiotoxicity focused on measuring Thymoma, Thymic carcinoma, Proton radiotherapy
Eligibility Criteria
Inclusion Criteria:
- Histological or cytological diagnosis of thymoma or thymic carcinoma.
- With radical surgery: stage III and IVa and selected stage II with type B2, B3 and thymic carcinoma according to local routine. With non-radical surgery (R1 or R2) or inoperable patient/ patient refusing surgery: stage I - IVa, any histology
- PS WHO 0 - 2.
- FEV1 > 1L or >40 % of predicted and CO diffusion capacity > 40% of predicted (postoperative measures)
- Age >18 years, no upper age limit.
- Written informed consent from patients.
Exclusion Criteria:
- Masaoka-Koga stage IVb (distant metastases).
- Pregnancy.
- Serious concomitant systemic disorder incompatible with the study.
- Tumour motion > 0.5 cm on two repeated 4DCT
Sites / Locations
- Department of Oncology, Norrlands UniversitetssjukhusRecruiting
- Department of Oncology, Karolinska University Hospital
- Department of Oncology, Sahlgrenska University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Proton radiotherapy
Arm Description
Proton radiotherapy with RBE doses: Patients with radical surgery and unfavourable histology (B2, B3, C) and/or Masaoka-Koga stage III, IVa: 2 Gy(RBE), once daily, five days a week to a total dose of 50 Gy(RBE). Patients with non-radical surgery (R1 resection) regardless of stage and histology: 2.3 Gy(RBE), once daily, 5 days a week to a total dose of 57.5 Gy(RBE) Inoperable patients regardless of stage and histology and patients with R2 non-radical resection: 2.5 Gy (RBE), once daily, 5 days a week to a total dose of 62.5 Gy(RBE)
Outcomes
Primary Outcome Measures
Cardiotoxicity and pulmonary toxicity of therapy
Proportion of patients with cardiac and pulmonary toxicity measured by CTCAE 4.0 > Grade 2
Local tumor control
Freedom from tumor progression (CR,PR or SD) mesured by CT-scan
Secondary Outcome Measures
Quality of life questionnaire EORTC QLQ 30 (European Organisation for Research and Treatment of Cancer)
Scale from 1-100 for 30 items, higher score indicates a better situation.
Quality of life questionnaire LC13 (Lung cancer specific module of EORTC)
Scale from 1-100 for 13 items and higher score indicates worse symptoms.
Survival
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04822077
Brief Title
Study on Proton Radiotherapy of Thymic Malignancies
Acronym
PROTHYM
Official Title
PROTHYM - Phase II Non-randomized Study on Proton Radiotherapy Of Thymic Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2018 (Actual)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
April 1, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ass. Prof. Jan Nyman
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
This is a multicentre non-randomized phase II study of proton beam radiotherapy in patients with thymic epithelial tumours (i.e. thymoma and thymic carcinoma) in the post-operative setting or in inoperable patients with localized disease.
Patients not willing or for any reason unsuitable to undergo proton treatment will be asked to participate in a follow-up assessment after the regular photon treatment in the same manner as the included patients.
Primary endpoints are:Toxicity (e.g. cardiac and pulmonary toxicity) and Local control at 5 year Secondary endpoints: PFS, Overall survival, Quality of life, measured by EORTC QLQ 30 + LC 13 and relapse pattern
Detailed Description
All doses are recorded in Gy(RBE).
After having checked all eligibility criteria patients will receive:
Patients with radical surgery and unfavourable histology (B2, B3, C) and/or Masaoka-Koga stage III, IVa: 2 Gy(RBE), once daily, five days a week to a total dose of 50 Gy(RBE).
Patients with non-radical surgery (R1 resection) regardless of stage and histology: 2.3 Gy(RBE), once daily, 5 days a week to a total dose of 57.5 Gy(RBE)
Inoperable patients regardless of stage and histology and patients with R2 non-radical resection: 2.5 Gy (RBE), once daily, 5 days a week to a total dose of 62.5 Gy(RBE)
Patients not willing to participate in study will receive photon therapy according to local practice (≥45 Gy)
Induction or adjuvant chemotherapy may be used according to local practice. Concomitant chemotherapy is not allowed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiotoxicity, Pulmonary Toxicity, Thymus Neoplasms
Keywords
Thymoma, Thymic carcinoma, Proton radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Phase II study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Proton radiotherapy
Arm Type
Experimental
Arm Description
Proton radiotherapy with RBE doses:
Patients with radical surgery and unfavourable histology (B2, B3, C) and/or Masaoka-Koga stage III, IVa: 2 Gy(RBE), once daily, five days a week to a total dose of 50 Gy(RBE).
Patients with non-radical surgery (R1 resection) regardless of stage and histology: 2.3 Gy(RBE), once daily, 5 days a week to a total dose of 57.5 Gy(RBE)
Inoperable patients regardless of stage and histology and patients with R2 non-radical resection: 2.5 Gy (RBE), once daily, 5 days a week to a total dose of 62.5 Gy(RBE)
Intervention Type
Radiation
Intervention Name(s)
Proton radiation
Intervention Description
Patients with radical surgery and unfavourable histology (B2, B3, C) and/or Masaoka-Koga stage III, IVa: 2 Gy(RBE), once daily, five days a week to a total dose of 50 Gy(RBE).
Patients with non-radical surgery (R1 resection) regardless of stage and histology: 2.3 Gy(RBE), once daily, 5 days a week to a total dose of 57.5 Gy(RBE)
Inoperable patients regardless of stage and histology and patients with R2 non-radical resection: 2.5 Gy (RBE), once daily, 5 days a week to a total dose of 62.5 Gy(RBE)
Primary Outcome Measure Information:
Title
Cardiotoxicity and pulmonary toxicity of therapy
Description
Proportion of patients with cardiac and pulmonary toxicity measured by CTCAE 4.0 > Grade 2
Time Frame
At 60 months from treatment
Title
Local tumor control
Description
Freedom from tumor progression (CR,PR or SD) mesured by CT-scan
Time Frame
At 60 months from treatment
Secondary Outcome Measure Information:
Title
Quality of life questionnaire EORTC QLQ 30 (European Organisation for Research and Treatment of Cancer)
Description
Scale from 1-100 for 30 items, higher score indicates a better situation.
Time Frame
At 60 months from treatment
Title
Quality of life questionnaire LC13 (Lung cancer specific module of EORTC)
Description
Scale from 1-100 for 13 items and higher score indicates worse symptoms.
Time Frame
At 60 months from treatment
Title
Survival
Description
Overall survival
Time Frame
From treatment and for 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological or cytological diagnosis of thymoma or thymic carcinoma.
With radical surgery: stage III and IVa and selected stage II with type B2, B3 and thymic carcinoma according to local routine. With non-radical surgery (R1 or R2) or inoperable patient/ patient refusing surgery: stage I - IVa, any histology
PS WHO 0 - 2.
FEV1 > 1L or >40 % of predicted and CO diffusion capacity > 40% of predicted (postoperative measures)
Age >18 years, no upper age limit.
Written informed consent from patients.
Exclusion Criteria:
Masaoka-Koga stage IVb (distant metastases).
Pregnancy.
Serious concomitant systemic disorder incompatible with the study.
Tumour motion > 0.5 cm on two repeated 4DCT
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Nyman, Ass.prof.
Phone
+46313421000
Ext
27927
Email
jan.nyman@oncology.gu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Hallqvist, MD, PhD
Phone
+46739845114
Email
andreas.hallqvist@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hillevi Rylander, MD
Organizational Affiliation
Head of Skandion Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Department of Oncology, Norrlands Universitetssjukhus
City
Umeå
State/Province
Norrland
ZIP/Postal Code
901 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikael Johansson, MD PhD
Phone
0046703711414
Email
mikael.johansson@onkologi.umu.se
First Name & Middle Initial & Last Name & Degree
Per Bergström, MD PhD
Email
per.bergstrom@vll.se
First Name & Middle Initial & Last Name & Degree
Mikael Johansson, MD PhD
First Name & Middle Initial & Last Name & Degree
Per Bergström, MD
Facility Name
Department of Oncology, Karolinska University Hospital
City
Stockholm
State/Province
Stockholm County
ZIP/Postal Code
171 76
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Signe Friesland, MD PhD
Email
signe.friesland@sll.se
First Name & Middle Initial & Last Name & Degree
Michael Gubanski, MD PhD
Email
michael.gubanski@sll.se
First Name & Middle Initial & Last Name & Degree
Signe Friesland, MD PhD
First Name & Middle Initial & Last Name & Degree
Michael Gubanski, MD PhD
Facility Name
Department of Oncology, Sahlgrenska University Hospital
City
Gothenburg
State/Province
Västra Götaland
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Nyman, Ass prof
Phone
0046313427927
Email
jan.nyman@oncology.gu.se
First Name & Middle Initial & Last Name & Degree
Andreas Hallqvist, MD, PhD
Phone
+46739845114
Email
andreas.hallqvist@vgregion.se
First Name & Middle Initial & Last Name & Degree
Andreas Hallqvist, MD PhD
First Name & Middle Initial & Last Name & Degree
Annica Ravn-Fischer, MD phD
First Name & Middle Initial & Last Name & Degree
Hillevi Rylander, MD
First Name & Middle Initial & Last Name & Degree
Anna Bäck, PhD
First Name & Middle Initial & Last Name & Degree
Erik Lundin, MD
First Name & Middle Initial & Last Name & Degree
Jens Engleson, MD
First Name & Middle Initial & Last Name & Degree
Jan Nyman, Ass prof
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The aim is that the study will be published in international journals. A separate publication will include result of the cardiological data The Vancouver declaration (Br Med J:296, 401-405, 1988) should be followed in all publications based on this study.
Citations:
PubMed Identifier
25260491
Citation
Chang JY, Li H, Zhu XR, Liao Z, Zhao L, Liu A, Li Y, Sahoo N, Poenisch F, Gomez DR, Wu R, Gillin M, Zhang X. Clinical implementation of intensity modulated proton therapy for thoracic malignancies. Int J Radiat Oncol Biol Phys. 2014 Nov 15;90(4):809-18. doi: 10.1016/j.ijrobp.2014.07.045. Epub 2014 Sep 24.
Results Reference
result
PubMed Identifier
20859129
Citation
Gomez D, Komaki R. Technical advances of radiation therapy for thymic malignancies. J Thorac Oncol. 2010 Oct;5(10 Suppl 4):S336-43. doi: 10.1097/JTO.0b013e3181f20ea2.
Results Reference
result
PubMed Identifier
26895711
Citation
Vogel J, Berman AT, Lin L, Pechet TT, Levin WP, Gabriel P, Khella SL, Singhal S, Kucharczuk JK, Simone CB 2nd. Prospective study of proton beam radiation therapy for adjuvant and definitive treatment of thymoma and thymic carcinoma: Early response and toxicity assessment. Radiother Oncol. 2016 Mar;118(3):504-9. doi: 10.1016/j.radonc.2016.02.003. Epub 2016 Feb 16.
Results Reference
result
PubMed Identifier
16332601
Citation
Bjork-Eriksson T, Bjelkengren G, Glimelius B. The potentials of proton beam radiation therapy in malignant lymphoma, thymoma and sarcoma. Acta Oncol. 2005;44(8):913-7. doi: 10.1080/02841860500355983.
Results Reference
result
Learn more about this trial
Study on Proton Radiotherapy of Thymic Malignancies
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