Non Small Cell Lung Cancer Clinical Trial
— ICDOfficial title:
Detection of Circulating Biomarkers of Immunogenic Cell Death After Radiotherapy and Chemotherapy: An Exploratory Study
NCT number | NCT02921854 |
Other study ID # | ICD |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 4, 2017 |
Est. completion date | June 19, 2019 |
Verified date | August 2019 |
Source | Maastricht Radiation Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this exploratory study, the investigators will investigate if markers (molecular and immunological) of ICD or anti-tumor immunity (exosomal or molecular) can be detected in the serum of patients after high-dose radiotherapy alone or concurrent cisplatin-doublet therapy and radiotherapy. For each patient: withdraw blood at three times during treatment for analysis.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 19, 2019 |
Est. primary completion date | June 19, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female, aged 18 years or above. - Diagnosed with non-small cell lung cancer - Scheduled to receive one of the following two therapeutic strategies: - Concurrent cisplatin-doublet chemotherapy and radiotherapy (minimal dose of 60 Gy in fractionated non-ablative doses) in patients with stage III NSCLC - SBRT for stage I NSCLC: 54Gy in 3 fractions, 48 Gy in 4 fractions or 60 Gy in 8 or 5 fractions - Is able and willing to comply with all trial requirements. Exclusion Criteria: 1. Chronic use of corticosteroids, except when used as anti-emetics for chemotherapy or inhalers 2. NSAIDs taken until 5 days before radiotherapy or during radiation (low dose Aspirin at a maximum of 160 mg/day, is allowed) 3. Active auto-immune diseases 4. Immunosuppressive medication |
Country | Name | City | State |
---|---|---|---|
Belgium | Unuversity Hospitals Leuven | Leuven | |
Netherlands | MAASTRO clinic | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht Radiation Oncology | Universitaire Ziekenhuizen Leuven |
Belgium, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes of relative protein expression, linked to vascular damage | 5 weeks (during radiotherapy) | ||
Primary | Changes of relative protein expression / derived exosomes, linked to ICD | 5 weeks (during radiotherapy) | ||
Primary | Changes of lipid profile for plasma / plasma, linked to ICD | 5 weeks (during radiotherapy) | ||
Secondary | Changes of relative protein expression, linked to Th1/Th2 subsets | 5 weeks (during radiotherapy) |
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