Radiation Impact on Thromboembolic Events

Malignant Neoplasm Clinical Trial

— RIT  

Official title:

Radiation Therapy and Venous Thromboembolic Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696447
• Other study ID #: 2015-09
• Status: Completed
• Start date: June 14, 2016
• Est. completion date: November 25, 2019

Study information

• Verified date: January 2020
• Source: Institut de Cancérologie de la Loire
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the present study is to determine the frequency and to identify main risk factors for venous thromboembolism of venous thromboembolic complications in a population of cancer patients treated with a curative intent by ionizing radiation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: November 25, 2019
• Est. primary completion date: December 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient with a solid cancer (all locations) treated with radiation therapy and / or brachytherapy as curative intent

• to be 18

Exclusion Criteria:

• Patient with metastatic cancer,

• Patients whose follow-up at 6 months is not possible

• Patient receiving an anti-coagulative medication (curative doses)

• Pregnant or breastfeeding women,

• Person under protection of justice or unable to give consent

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms
• Thromboembolism

Intervention

Biological:
• Biomarkers assays
D-Dimer assays, C-reactive protein, blood platelets assays

Locations

Country	Name	City	State
France	CH de Roanne	Roanne
France	Institut de cancérologie Lucien Neuwirth	Saint-Priest-en-Jarez

Sponsors (3)

Lead Sponsor	Collaborator
Institut de Cancérologie de la Loire	Centre Hospitalier Universitaire de Saint Etienne, CH Roanne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous Thromboembolism event	All venous thromboembolism, whether symptomatic or discovered incidentally, objectified (CT angiography, lung scintigraphy, venous Doppler) between J1 of radiation treatment, up to 6 months following discontinuation of radiation treatment	6 months
Secondary	Dosage of D-dimer		6 months
Secondary	C-reactive protein		6 months
Secondary	Complete blood count		6 months
Secondary	Time of occurrence of VTE	Time of occurrence of VTE	6 months
Secondary	Symptomatic VTE	Symptomatic VTE.	6 months