Secondary Cancer Risk After Radiation Therapy for Rectal Cancer

Neoplasms, Second Primary Clinical Trial

Official title:

Estimation of Second Cancer Risk in Patients Planned With Different Radiotherapy Regimes for Rectal Cancer - A Planning Study and Model-based Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572362
• Other study ID #: KEK-ZH-Nr. 2014-0255
• Status: Completed
• Phase: N/A
• First received: October 4, 2015
• Last updated: December 11, 2016
• Start date: August 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Kantonsspital Graubuenden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

Retrospective study comparing dose distribution of 3D conformal radiotherapy (3DCRT) and volumetric-modulated arc therapy (VMAT) to estimate secondary cancer risk for patients having had radiation therapy for rectal cancer. Twenty-five patients are included in this study. Planning CT scans are used for comparison of dose distribution and calculation of second cancer risk.

Description:

A model-based Analysis calculating the organ-specific excess lifetime attributable risk using the planning CT data sets of 25 patients to estimate second cancer risk for patients after radiotherapy for rectal cancer comparing conventional 3DCRT with VAMT techniques.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Male/Female > 18 years of age

• pre or postoperative radiation therapy for rectal cancer

• Planning CT

Exclusion Criteria:

• Planning CT not available

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Neoplasms, Second Primary
• Rectal Neoplasms

Intervention

Other:
• No intervention in this retrospective study
No Intervention in this retrospective Analysis. All patients included did receive Radiation therapy Independent of this study

Locations

Country	Name	City	State
Switzerland	Klinik Hirslanden, Institute for Radiotherapy	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Kantonsspital Graubuenden	Klinik Hirslanden, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculation of the organ-specific excess lifetime attributable risk (LAR) (%)	LAR is calculated for variable Ages at exposure	60 years (model-based calculation)	No