Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
All doses are recorded in Gy(RBE).
After having checked all eligibility criteria patients will receive:
Induction or adjuvant chemotherapy may be used according to local practice. Concomitant chemotherapy is not allowed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton radiotherapy | Experimental | Proton radiotherapy with RBE doses:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton radiation | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiotoxicity and pulmonary toxicity of therapy | Proportion of patients with cardiac and pulmonary toxicity measured by CTCAE 4.0 > Grade 2 | At 60 months from treatment |
| Local tumor control | Freedom from tumor progression (CR,PR or SD) mesured by CT-scan | At 60 months from treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 60 months from treatment |
| Quality of life questionnaire LC13 (Lung cancer specific module of EORTC) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Nyman, Ass.prof. | Contact | +46313421000 | 27927 | jan.nyman@oncology.gu.se |
| Andreas Hallqvist, MD, PhD | Contact | +46739845114 | andreas.hallqvist@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Hillevi Rylander, MD | Head of Skandion Clinic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Norrlands Universitetssjukhus | Recruiting | Umeå | Norrland | 901 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25260491 | Result | 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. | |
| 20859129 | Result |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 21, 2017 | Mar 16, 2021 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| D013953 | Thymus Neoplasms |
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
Phase II study
Not provided
Not provided
Not provided
Not provided
|
Scale from 1-100 for 13 items and higher score indicates worse symptoms. |
| At 60 months from treatment |
| Survival | Overall survival | From treatment and for 5 years |
| Department of Oncology, Karolinska University Hospital | Not yet recruiting | Stockholm | Stockholm County | 171 76 | Sweden |
|
| Department of Oncology, Sahlgrenska University Hospital | Recruiting | Gothenburg | Västra Götaland County | 413 45 | Sweden |
|
| 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. |
| 26895711 | Result | 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. |
| 16332601 | Result | 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. |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |