CancerNCT02500173
Analysis of Effects and Side Effects in Patients Undergoing Radiation Therapy
An observational study of Cancer, run by Kantonsspital Graubünden at 1 site in Switzerland.
Trial summary
To collect and analyze effects and side effects in patients undergoing radiotherapy. This study investigates how analysis of effects and side effects will influence outcome of patients. These retrospectively collected data allow to adapt and improve radiotherapy treatment regimens . Read more about this study
- Who is it for?
- Ages 20 to 105 years
- Conditions the study is for
- Cancer
- What is being tested?
- Radiation
- Type of treatment
- Surgery or procedure
- How many people
- 1,800 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2015to 21 Oct 2020
- 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 20 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing radiotherapy at the Kantonsspital Graubuenden
Who may be able to join
- Patients undergoing radiotherapy at the Kantonsspital Graubuenden
Who cannot join
- No radiotherapy at Kantonsspital Graubuenden
- Age: < 20 years, > 105 years
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Graubuenden, Department of Radiaton Oncology
Chur, 7000
About this study
Official title: Analysis of Effects and Side Effects in Patients Undergoing Radiation Therapy - Quality Control Using Clinical Database
To collect and analyze effects and side effects in patients undergoing radiotherapy.
This study investigates how analysis of effects and side effects will influence outcome of patients. These retrospectively collected data allow to adapt and improve radiotherapy treatment regimens .
Read the detailed description
Effects and side effects in patients undergoing radiotherapy will be collected over the next five years (2015-2020). It is planned to include 600 to 650 new patients referred for radiotherapy per calender year. It is estimated that 3000 patients will be included at the end of the study after five years. Patient Information on diseae and treatment will be collected and analyzed. Common statistical algorithms will be performed for outcome analysis.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Radiation therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effects in patients undergoing radiotherapy (CTCAE v4.03)
acute and late side effects according to CTCAE
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study start1 Jun 2015
- Primary completion21 Oct 2020
- Study completion21 Oct 2020
Why it stopped: General Informed Consent has been introduced at the Hospital, no need for study anymore
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Graubünden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel R Zwahlen, MD MBA, Study chair, Kantonsspital Winterthur, Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500173
- Sponsor's protocol ID
- KEK-ZH-Nr.2015-0221
- Status last verified
- Mar 2021
- First submitted
- 18 Jun 2015
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Effects and Side Effects in Patients Undergoing Radiation Therapy - Quality Control Using Clinical Database
- ClinicalTrials.gov ID
- NCT02500173
- Acronym / sponsor ID
- KEK-ZH-Nr.2015-0221
- Conditions
- Cancer
- Keywords
- radiotherapy, side effects
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: General Informed Consent has been introduced at the Hospital, no need for study anymore
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Kantonsspital GraubündenUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 16 Jul 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.
To collect and analyze effects and side effects in patients undergoing radiotherapy.
This study investigates how analysis of effects and side effects will influence outcome of patients. These retrospectively collected data allow to adapt and improve radiotherapy treatment regimens .
Detailed description
Effects and side effects in patients undergoing radiotherapy will be collected over the next five years (2015-2020). It is planned to include 600 to 650 new patients referred for radiotherapy per calender year. It is estimated that 3000 patients will be included at the end of the study after five years. Patient Information on diseae and treatment will be collected and analyzed. Common statistical algorithms will be performed for outcome analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing radiotherapy at the Kantonsspital Graubuenden
Key inclusion criteria (1 listed)
- Patients undergoing radiotherapy at the Kantonsspital Graubuenden
Key exclusion criteria (2 listed)
- No radiotherapy at Kantonsspital Graubuenden
- Age: < 20 years, > 105 years
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 |
|---|---|---|
| RadiationRadiation therapy | Radiation | – |
Primary outcome
Side effects in patients undergoing radiotherapy (CTCAE v4.03)
Time frame: 5 Years
acute and late side effects according to CTCAE
Results and safety
The study was stopped early (reason given: General Informed Consent has been introduced at the Hospital, no need for study anymore). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Homepage Kantonsspital GraubündenLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 study chair
Kantonsspital Winterthur, Department of Radiation Oncology
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 Cancer, 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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 9 Mar 2021. 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 was stopped early (reason given: General Informed Consent has been introduced at the Hospital, no need for study anymore). Results are not available in the source record.
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?
Side effects in patients undergoing radiotherapy (CTCAE v4.03) (time frame: 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2021.