Standard Follow-up Program (SFP) for Lung Cancer Patients Treated With Radiotherapy or Chemoradiation

April 28, 2026 updated by: University Medical Center Groningen

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

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Provincie Groningen
      • Groningen, Provincie Groningen, Netherlands, 9700RB
        • Recruiting
        • University Medical Center Groningen
        • Contact:
        • Principal Investigator:
          • Robin Wijsman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer - Limited Disease (SCLC-LD) or thymoma or lungmetastases (treated with stereotactic radiotherapy), receiving radiotherapy dose > 40 Gy.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Robin Wijsman, MD, University Medical Center Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (Estimated)

April 21, 2015

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

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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