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Recruiting

NCT Number: 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.

Recruiting

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, Provincie Groningen, 9700RB, Netherlands

Location status: Recruiting

Location contact

Robin Wijsman, MD

CONTACT

[email protected]

+31503615532

Robin Wijsman, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

Other names: Chemoradiation

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Overall survival

    Time frame: at 1 year after first day of radiation therapy

  2. Overall survival

    Time frame: at 2 years after first day of radiation therapy

  3. Overall survival

    Time frame: at 3 years after first day of radiation therapy

  4. Overall survival

    Time frame: at 4 years after first day of radiation therapy

  5. Overall survival

    Time frame: at 5 years after first day of radiation therapy

  6. Loco-regional tumor control

    Time frame: at 1 year after first day of radiation therapy

  7. Loco-regional tumor control

    Time frame: at 2 years after first day of radiation therapy

  8. Loco-regional tumor control

    Time frame: at 3 years after first day of radiation therapy

Other outcomes

  1. Patient-rated symptoms and Quality-of-Life

    Time frame: Within 1 week before or after last day of radiation therapy

  2. Patient-rated symptoms and Quality-of-Life

    Time frame: at 3 months after first day of radiation therapy

  3. Patient-rated symptoms and Quality-of-Life

    Time frame: at 6 months after first day of radiation therapy

  4. Patient-rated symptoms and Quality-of-Life

    Time frame: at one year after first day of radiation therapy

  5. Patient-rated symptoms and Quality-of-Life

    Time frame: at 2 years after first day of radiation therapy

  6. Patient-rated symptoms and Quality-of-Life

    Time frame: at 3 years after first day of radiation therapy

  7. Patient-rated symptoms and Quality-of-Life

    Time frame: at 4 years after first day of radiation therapy

  8. Patient-rated symptoms and Quality-of-Life

    Time frame: at 5 years after first day of radiation therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Robin Wijsman, MD PhD

CONTACT

[email protected]

+31503615532

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Important dates

Study start
2013
Primary completion
2030
Study completion
2031
First posted
Apr 21, 2015
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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