Clinical trial NCT04822077: Study on Proton Radiotherapy of Thymic Malignancies
Official title: PROTHYM - Phase II Non-randomized Study on Proton Radiotherapy Of Thymic Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiotoxicity
Pulmonary Toxicity
Thymus Neoplasms
Keywords: Thymoma
Thymic carcinoma
Proton radiotherapy
Lead sponsor: Swedish Lung Cancer Study Group
Sponsor class: NETWORK
First posted: 2021-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase II study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cardiotoxicity and pulmonary toxicity of therapy
timeFrame: At 60 months from treatment
measure: Local tumor control
timeFrame: At 60 months from treatment
Secondary outcomes:
measure: Quality of life questionnaire EORTC QLQ 30 (European Organisation for Research and Treatment of Cancer)
timeFrame: At 60 months from treatment
measure: Quality of life questionnaire LC13 (Lung cancer specific module of EORTC)
timeFrame: At 60 months from treatment
measure: Survival
timeFrame: From treatment and for 5 years
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Oncology, Norrlands Universitetssjukhus
state: Norrland
city: Stockholm
country: Sweden
facility: Department of Oncology, Karolinska University Hospital
state: Stockholm County
city: Gothenburg
country: Sweden
facility: Department of Oncology, Sahlgrenska University Hospital
state: Västra Götaland
Study officials:
affiliation: Head of Skandion Clinic
name: Hillevi Rylander, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.