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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02421718
• Other study ID #: SFP LUNG
• Status: Recruiting
• Start date: March 2013
• Est. completion date: January 2028

Study information

• Verified date: February 2024
• Source: University Medical Center Groningen
• Contact: Robin Wijsman, MD PhD
• Phone: +31503615532
• Email: r.wijsman[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: January 2028
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• Radiotherapy

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-rated symptoms and Quality-of-Life		Within 1 week before or after last day of radiation therapy
Other	Patient-rated symptoms and Quality-of-Life		at 3 months after first day of radiation therapy
Other	Patient-rated symptoms and Quality-of-Life		at 6 months after first day of radiation therapy
Other	Patient-rated symptoms and Quality-of-Life		at one year after first day of radiation therapy
Other	Patient-rated symptoms and Quality-of-Life		at 2 years after first day of radiation therapy
Other	Patient-rated symptoms and Quality-of-Life		at 3 years after first day of radiation therapy
Other	Patient-rated symptoms and Quality-of-Life		at 4 years after first day of radiation therapy
Other	Patient-rated symptoms and Quality-of-Life		at 5 years after first day of radiation therapy
Primary	Acute toxicity	esophagitis (Common Terminology Criteria for Adverse Events, version 4.0)	Highest during and within 2 weeks after last day of radiation therapy
Primary	Late toxicity	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	Overall survival		at 1 year after first day of radiation therapy
Secondary	Overall survival		at 2 years after first day of radiation therapy
Secondary	Overall survival		at 3 years after first day of radiation therapy
Secondary	Overall survival		at 4 years after first day of radiation therapy
Secondary	Overall survival		at 5 years after first day of radiation therapy
Secondary	Loco-regional tumor control		at 1 year after first day of radiation therapy
Secondary	Loco-regional tumor control		at 2 years after first day of radiation therapy
Secondary	Loco-regional tumor control		at 3 years after first day of radiation therapy