Neoplasms, Second PrimaryNCT02572362
Secondary Cancer Risk After Radiation Therapy for Rectal Cancer
An observational study of Neoplasms, Second Primary, run by Kantonsspital Graubünden at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Neoplasms, Second Primary
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2015to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Male/Female > 18 years of age
- pre or postoperative radiation therapy for rectal cancer
- Planning CT
Who cannot join
- Planning CT not available
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Klinik Hirslanden, Institute for Radiotherapy
Zurich, CH-8032
About this study
Official title: Estimation of Second Cancer Risk in Patients Planned With Different Radiotherapy Regimes for Rectal Cancer - A Planning Study and Model-based Analysis
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.
Read the 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.
- Conditions
- Neoplasms, Second Primary
- Being tested
- No intervention in this retrospective study
- Medical subject headings
- Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention in this retrospective studyOther
No Intervention in this retrospective Analysis. All patients included did receive Radiation therapy Independent of this study
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation of the organ-specific excess lifetime attributable risk (LAR) (%)
LAR is calculated for variable Ages at exposure
Measured: 60 years (model-based calculation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasms, Second PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Graubünden
- Sponsor type
- University, hospital or other
- Collaborators
- Klinik Hirslanden, Zurich
- Responsible party
- Principal investigator, Daniel Rudolf Zwahlen, Kantonsspital Graubünden
- Investigators
- Daniel R Zwahlen, MD, MBA, Principal investigator, Kantonsspital Graubünden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572362
- Sponsor's protocol ID
- KEK-ZH-Nr. 2014-0255
- Status last verified
- Dec 2016
- First submitted
- 4 Oct 2015
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27832799
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Second Cancer Risk in Patients Planned With Different Radiotherapy Regimes for Rectal Cancer - A Planning Study and Model-based Analysis
- ClinicalTrials.gov ID
- NCT02572362
- Acronym / sponsor ID
- KEK-ZH-Nr. 2014-0255
- Conditions
- Neoplasms, Second Primary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Kantonsspital GraubündenUniversity, hospital or other
- Collaborators
- Klinik Hirslanden, Zurich
- Study start
- Aug 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- Male/Female > 18 years of age
- pre or postoperative radiation therapy for rectal cancer
- Planning CT
Key exclusion criteria (1 listed)
- Planning CT not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention in this retrospective studyNo Intervention in this retrospective Analysis. All patients included did receive Radiation therapy Independent of this study | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Derived from this study: PubMed 27832799Zwahlen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel R Zwahlen, MD, MBA principal investigator
Kantonsspital Graubünden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, Second Primary, run by Kantonsspital Graubünden at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation of the organ-specific excess lifetime attributable risk (LAR) (%) (time frame: 60 years (model-based calculation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02572362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2016.