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

ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with NSCLC or SCLC-LD or thymoma or lung metastases (treated with stereotactic radiotherapy)

Patients receiving radiotherapy dose > 40 Gy

Disqualifiers

Failure to comply with any of the inclusion criteria

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Radiotherapy

    Radiation

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Acute toxicity

esophagitis (Common Terminology Criteria for Adverse Events, version 4.0)

Time frame
Highest during and within 2 weeks after last day of radiation therapy
2

Late toxicity

esophagitis (Common Terminology Criteria for Adverse Events, version 4.0); pneumonitis (Common Terminology Criteria for Adverse Events, version 4.0)

Time frame
Highest within one year after last day of radiation therapy

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

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

Sponsors and contacts

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