AP-IS: Lung cancer, Ablative high Precision radiotherapy and the Immune System: Evaluation of the immune-modulatory effects of stereotactic body radiation therapy (SBRT) of pulmonary lesions

Phase 1

Recruiting

Conditions: C34
Malignant neoplasm of bronchus and lung

Registration Number: DRKS00011266

Lead Sponsor: niversitätsklinikum Freiburg, Klinik für Strahlenheilkunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 75

Inclusion Criteria

• Primary or recurrent non-metastatic NSCLC or
• Solitary or oligometastasic pulmonary metastasis of otherwise controlled malignant
• Lesions confirmed by either histology or cytology or clear imaging signs of malignant tumors
• Patient scheduled and eligible for SBRT with curative intention
• Whole body FDG-PET scan + WB-CT or CT of chest and upper abdomen
• Written informed consent must be given according to ICH/GCP, and national/local regulations
• Adequate birth control measures during the study treatment period

Exclusion Criteria

• Other active or significantly bone marrow suppressing malignancy
• WHO performance status < 2
• Prior radiotherapy to chest and/or mediastinum within 3 months before the start of SBRT
• Chemotherapy and/or targeted treatment within 3 months before the start of SBRT
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Pregnancy

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase of CTL counts six weeks after SBRT compared to baseline

Secondary Outcome Measures

Name	Time	Method
- Significant changes in number and phenotype of lymphocytes<br>- Significant changes in number and phenotype of myeloid cells <br>- Significant changes in circulating biomarkers of immune response in the plasma <br>- Association between treatment related data and changes in different biomarkers of immune response<br>- Association between treatment outcomes and changes in different biomarkers of immune response <br>- Differences in the above mentioned endpoints between patients with or without prior / simultaneous radiation and /or systemic therapy