NCT02572362

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

1.3 years

First QC Date

October 4, 2015

Last Update Submit

December 11, 2016

Conditions

Neoplasms, Second Primary

Outcome Measures

Primary Outcomes (1)

  • Calculation of the organ-specific excess lifetime attributable risk (LAR) (%)

    LAR is calculated for variable Ages at exposure

    60 years (model-based calculation)

Interventions

No intervention in this retrospective studyOTHER

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • Planning CT not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik Hirslanden, Institute for Radiotherapy

Zurich, CH-8032, Switzerland

Location

Related Publications (1)

  • Zwahlen DR, Bischoff LI, Gruber G, Sumila M, Schneider U. Estimation of second cancer risk after radiotherapy for rectal cancer: comparison of 3D conformal radiotherapy and volumetric modulated arc therapy using different high dose fractionation schemes. Radiat Oncol. 2016 Nov 10;11(1):149. doi: 10.1186/s13014-016-0723-6.

    PMID: 27832799DERIVED

MeSH Terms

Conditions

Neoplasms, Second Primary

Condition Hierarchy (Ancestors)

Neoplasms

Study Officials

  • Daniel R Zwahlen, MD, MBA

    Kantonsspital Graubuenden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MBA

Study Record Dates

First Submitted

October 4, 2015

First Posted

October 8, 2015

Study Start

August 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 13, 2016

Record last verified: 2016-12

Locations

CH(1)