Phase II non-randomized study on proton radiotherapy of thymic malignancies

Phase 2

Recruiting

• Conditions: cancer; Thymoma; 10027655

• Registration Number: NL-OMON51962
• Lead Sponsor: Swedish Lung Cancer Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Histological or cytological diagnosis of thymoma or thymic carcinoma
- With radical surgery stage III, IV and selected stage II with type B2, B3 or
thymic carcinoma according to local routine
- With non-radical surgery (R1 or R2), stage I - IVa, any histology
- Medically inoperable or 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
(post-operative measures)
- Age >/18 years, no upper age limit
- Written informed consent

Exclusion Criteria

- Masoaka-Koga stage IVb (distant metastases)
- Pregnancy
- Serious concomittant systemic disorder incompatible with the study
- Tumour motion >0,5cm on two repeated 4DCT

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Toxicity (e.g. cardiac and pulmonary toxicity)<br /><br>- Local control at 5 year</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- PFS<br /><br>- Overall survival<br /><br>- Quality of life, measured by EORTC QLQ30 + LC14<br /><br>- Relapse pattern</p><br>