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

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT02421718
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute toxicity	Highest during and within 2 weeks after last day of radiation therapy	esophagitis (Common Terminology Criteria for Adverse Events, version 4.0)
Late toxicity	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 Outcome Measures

Name	Time	Method
Loco-regional tumor control	at 3 years after first day of radiation therapy
Overall survival	at 5 years after first day of radiation therapy

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands