Study on Proton Radiotherapy of Thymic Malignancies

Cardiotoxicity Clinical Trial

— PROTHYM  

Official title:

PROTHYM - Phase II Non-randomized Study on Proton Radiotherapy Of Thymic Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04822077
• Other study ID #: PROTHYM 2.2
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2018
• Est. completion date: April 1, 2029

Study information

• Verified date: March 2021
• Source: Swedish Lung Cancer Study Group
• Contact: Jan Nyman, Ass.prof.
• Phone: +46313421000
• Email: jan.nyman[@]oncology.gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 1, 2029
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiotoxicity
• Pulmonary Toxicity
• Thymoma
• Thymus Neoplasms

Intervention

Radiation:
• 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)

Locations

Country	Name	City	State
Sweden	Department of Oncology, Sahlgrenska University Hospital	Gothenburg	Västra Götaland
Sweden	Department of Oncology, Karolinska University Hospital	Stockholm	Stockholm County
Sweden	Department of Oncology, Norrlands Universitetssjukhus	Umeå	Norrland

Sponsors (1)

Lead Sponsor	Collaborator
Ass. Prof. Jan Nyman

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Björk-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. Review. — View 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. d — View 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. Review. — View 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 tox — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Local tumor control	Freedom from tumor progression (CR,PR or SD) mesured by CT-scan	At 60 months from treatment
Secondary	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
Secondary	Quality of life questionnaire LC13 (Lung cancer specific module of EORTC)	Scale from 1-100 for 13 items and higher score indicates worse symptoms.	At 60 months from treatment
Secondary	Survival	Overall survival	From treatment and for 5 years