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Secondary Cancer Risk After Radiation Therapy for Rectal Cancer

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ClinicalTrials.gov Identifier: NCT02572362
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : December 13, 2016
Sponsor:
Collaborator:
Klinik Hirslanden, Zurich
Information provided by (Responsible Party):
Daniel Rudolf Zwahlen, Kantonsspital Graubuenden

Brief 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.

Condition or disease Intervention/treatment
Neoplasms, Second Primary Other: No intervention in this retrospective study

Detailed 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.

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Study Type : Observational
Actual Enrollment : 25 participants
Time Perspective: Retrospective
Official Title: Estimation of Second Cancer Risk in Patients Planned With Different Radiotherapy Regimes for Rectal Cancer - A Planning Study and Model-based Analysis
Study Start Date : August 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

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


Primary Outcome Measures :
  1. Calculation of the organ-specific excess lifetime attributable risk (LAR) (%) [ Time Frame: 60 years (model-based calculation) ]
    LAR is calculated for variable Ages at exposure



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients having had radiation therapy for rectal cancer. Estimation of second cancer risk using data from planning CTs comparing dose Distribution using different Radiation therapy techniques (3DCRT vs VMAT).
Criteria

Inclusion Criteria:

  • Male/Female > 18 years of age
  • pre or postoperative radiation therapy for rectal cancer
  • Planning CT

Exclusion Criteria:

  • Planning CT not available

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572362


Locations
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Switzerland
Klinik Hirslanden, Institute for Radiotherapy
Zurich, Switzerland, CH-8032
Sponsors and Collaborators
Kantonsspital Graubuenden
Klinik Hirslanden, Zurich
Investigators
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Principal Investigator: Daniel R Zwahlen, MD, MBA Kantonsspital Graubuenden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel Rudolf Zwahlen, MD, MBA, Kantonsspital Graubuenden
ClinicalTrials.gov Identifier: NCT02572362     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2014-0255
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Neoplasms, Second Primary
Neoplasms