Analysis of Effects and Side Effects in Patients Undergoi... | NCT02500173

Studies
Analysis of Effects and Side Effects in Patients Undergoing Radiation Therapy

NCT02500173

Sponsor

Kantonsspital Graubuenden

Status

Terminated

Last Update Posted

Mar 9, 2021Actual

Enrollment

1,800Actual

Phase

Not provided

Conditions

Cancer

Interventions

Radiation

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

General Informed Consent has been introduced at the Hospital, no need for study anymore

Expanded Access Info

Start Date

Jun 1, 2015Actual

Primary Completion Date

Oct 21, 2020Actual

Completion Date

Oct 21, 2020Actual

First Submitted Date

Jun 18, 2015

First Submission Date that Met QC Criteria

Jul 15, 2015

First Posted Date

Jul 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2021

Last Update Posted Date

Mar 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 .

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,800Actual

Name	Type	Description	Arm Group Labels	Other Names
Radiation	Radiation	Radiation therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Side effects in patients undergoing radiotherapy (CTCAE v4.03)	acute and late side effects according to CTCAE	5 Years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing radiotherapy at the Kantonsspital Graubuenden

Exclusion Criteria:

No radiotherapy at Kantonsspital Graubuenden
Age: < 20 years, > 105 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

105 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing radiotherapy at the Kantonsspital Graubuenden

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel R Zwahlen, MD MBA	Kantonsspital Winterthur, Department of Radiation Oncology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kantonsspital Graubuenden, Department of Radiaton Oncology		Chur		7000	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided