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Coagulation System In STereotactic Radiotherapy Of NSCLC

Impact of Stereotactic Body Radiation Therapy on the Coagulation System in Patients With Non-small Cell Lung Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03893461
Acronym
CISTRON
Enrollment
110
Registered
2019-03-28
Start date
2019-03-26
Completion date
2022-12-31
Last updated
2021-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, NSCLC, Radiotherapy; Complications, Thromboembolism

Brief summary

The risk of thromboembolism is elevated in lung cancer patients. The present project investigates whether stereotactic body radiation therapy (SBRT) further increases the risk of thromboembolic disease in lung cancer patients. If coagulation is activated by SBRT, this study could form the basis of new clinical trials investigating whether lung cancer patients may benefit from thromboprophylaxis during and after stereotactic body radiation therapy.

Detailed description

In this study, the patients will have blood samples drawn three times (prior to start of stereotactic body radiation therapy, immediately after stereotactic body radiation therapy completion, four to six weeks after completing stereotactic body radiation therapy). The blood sample at the completion of stereotactic body radiation therapy is an extra compared to normal gathering of blood samples of patients with NSCLC treated with stereotactic body radiation therapy. Also extra glasses with blood will be gathered at each blood sample for storage in a biobank in order to be able to make future analysis on this material. There is a minimal risk of developing infection or hematoma in connection with blood sampling but we consider this risk to be negligible. The total volume of 120 ml blood drawn over a period of 6 weeks is an inconsiderable risk for the patient.

Interventions

RADIATIONx

Stereotactic body radiation therapy for localized NSCLC

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years * Planned stereotactic body radiation therapy of lung cancer

Exclusion criteria

* Inability to provide informed consent * Venous thrombosis within the last three months * Active cancer within the previous year except for lung cancer

Design outcomes

Primary

MeasureTime frameDescription
Changes in coagulationFrom start of SBRT to end and 5 weeks after SBRTendogenous thrombin

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026