Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2018-04-18
2029-04-01
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Proton radiotherapy
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)
Proton radiation
* 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)
Interventions
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Proton radiation
* 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)
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy.
* Serious concomitant systemic disorder incompatible with the study.
* Tumour motion \> 0.5 cm on two repeated 4DCT
18 Years
ALL
No
Sponsors
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Ass. Prof. Jan Nyman
NETWORK
Responsible Party
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Ass. Prof. Jan Nyman
Head of Swedish Lung Cancer Study Group, Ass. Prof.
Principal Investigators
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Hillevi Rylander, MD
Role: STUDY_DIRECTOR
Head of Skandion Clinic
Locations
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Department of Oncology, Norrlands Universitetssjukhus
Umeå, Norrland, Sweden
Department of Oncology, Karolinska University Hospital
Stockholm, Stockholm County, Sweden
Department of Oncology, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Mikael Johansson, MD PhD
Role: primary
Per Bergström, MD PhD
Role: backup
Signe Friesland, MD PhD
Role: primary
Michael Gubanski, MD PhD
Role: backup
Jan Nyman, Ass prof
Role: primary
Andreas Hallqvist, MD, PhD
Role: backup
References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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PROTHYM 2.2
Identifier Type: -
Identifier Source: org_study_id