- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02421718
Standard Follow-up Program (SFP) for Lung Cancer Patients Treated With Radiotherapy or Chemoradiation
Motive:
In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from lung cancer patients.
Goal:
To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.
A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Robin Wijsman, MD PhD
- Phone Number: +31503615532
- Email: r.wijsman@umcg.nl
Study Locations
-
-
-
Groningen, Netherlands, 9700RB
- Recruiting
- University Medical Center Groningen
-
Contact:
- Robin Wijsman, MD
- Phone Number: +31503615532
- Email: r.wijsman@umcg.nl
-
Principal Investigator:
- Robin Wijsman, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with NSCLC or SCLC-LD or thymoma or lung metastases (treated with stereotactic radiotherapy)
- Patients receiving radiotherapy dose > 40 Gy
Exclusion Criteria:
- Failure to comply with any of the inclusion criteria
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute toxicity
Time Frame: Highest during and within 2 weeks after last day of radiation therapy
|
esophagitis (Common Terminology Criteria for Adverse Events, version 4.0)
|
Highest during and within 2 weeks after last day of radiation therapy
|
Late toxicity
Time Frame: Highest within one year after last day of radiation therapy
|
esophagitis (Common Terminology Criteria for Adverse Events, version 4.0); pneumonitis (Common Terminology Criteria for Adverse Events, version 4.0)
|
Highest within one year after last day of radiation therapy
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: at 1 year after first day of radiation therapy
|
at 1 year after first day of radiation therapy
|
Overall survival
Time Frame: at 2 years after first day of radiation therapy
|
at 2 years after first day of radiation therapy
|
Overall survival
Time Frame: at 3 years after first day of radiation therapy
|
at 3 years after first day of radiation therapy
|
Overall survival
Time Frame: at 4 years after first day of radiation therapy
|
at 4 years after first day of radiation therapy
|
Overall survival
Time Frame: at 5 years after first day of radiation therapy
|
at 5 years after first day of radiation therapy
|
Loco-regional tumor control
Time Frame: at 1 year after first day of radiation therapy
|
at 1 year after first day of radiation therapy
|
Loco-regional tumor control
Time Frame: at 2 years after first day of radiation therapy
|
at 2 years after first day of radiation therapy
|
Loco-regional tumor control
Time Frame: at 3 years after first day of radiation therapy
|
at 3 years after first day of radiation therapy
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient-rated symptoms and Quality-of-Life
Time Frame: Within 1 week before or after last day of radiation therapy
|
Within 1 week before or after last day of radiation therapy
|
Patient-rated symptoms and Quality-of-Life
Time Frame: at 3 months after first day of radiation therapy
|
at 3 months after first day of radiation therapy
|
Patient-rated symptoms and Quality-of-Life
Time Frame: at 6 months after first day of radiation therapy
|
at 6 months after first day of radiation therapy
|
Patient-rated symptoms and Quality-of-Life
Time Frame: at one year after first day of radiation therapy
|
at one year after first day of radiation therapy
|
Patient-rated symptoms and Quality-of-Life
Time Frame: at 2 years after first day of radiation therapy
|
at 2 years after first day of radiation therapy
|
Patient-rated symptoms and Quality-of-Life
Time Frame: at 3 years after first day of radiation therapy
|
at 3 years after first day of radiation therapy
|
Patient-rated symptoms and Quality-of-Life
Time Frame: at 4 years after first day of radiation therapy
|
at 4 years after first day of radiation therapy
|
Patient-rated symptoms and Quality-of-Life
Time Frame: at 5 years after first day of radiation therapy
|
at 5 years after first day of radiation therapy
|
Collaborators and Investigators
Investigators
- Principal Investigator: Robin Wijsman, MD, University Medical Center Groningen
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SFP LUNG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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