NCT03893461

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
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thromboembolism
• Lung Cancer
• NSCLC
• Radiotherapy; Complications

Interventions

Type	Name	Description
RADIATION	x	Stereotactic body radiation therapy for localized NSCLC

Timeline

• Start date: 2019-03-26
• Primary completion: 2021-06-30
• Completion: 2022-12-31
• First posted: 2019-03-28
• Last updated: 2021-07-22

Locations

1 site across 1 country: Denmark