NCT02421718

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
65mo left

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Mar 2013Dec 2031

Study Start

First participant enrolled

March 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
15.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

17.8 years

First QC Date

April 7, 2015

Last Update Submit

April 28, 2026

Conditions

Lung Cancer

Keywords

Acute toxicityLate toxicityPrediction models

Outcome Measures

Primary Outcomes (2)

  • Acute toxicity

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

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

  • 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 Outcomes (8)

  • Overall survival

    at 1 year after first day of radiation therapy

  • Overall survival

    at 2 years after first day of radiation therapy

  • Overall survival

    at 3 years after first day of radiation therapy

  • Overall survival

    at 4 years after first day of radiation therapy

  • Overall survival

    at 5 years after first day of radiation therapy

  • +3 more secondary outcomes

Other Outcomes (8)

  • Patient-rated symptoms and Quality-of-Life

    Within 1 week before or after last day of radiation therapy

  • Patient-rated symptoms and Quality-of-Life

    at 3 months after first day of radiation therapy

  • Patient-rated symptoms and Quality-of-Life

    at 6 months after first day of radiation therapy

  • +5 more other outcomes

Interventions

RadiotherapyRADIATION
Also known as: Chemoradiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients with NSCLC or SCLC-LD or thymoma or lung metastases (treated with stereotactic radiotherapy)
  • Patients receiving radiotherapy dose \> 40 Gy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700RB, Netherlands

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

RadiotherapyChemoradiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsCombined Modality TherapyDrug Therapy

Study Officials

  • Robin Wijsman, MD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin Wijsman, MD PhD

CONTACT

+31503615532r.wijsman@umcg.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 21, 2015

Study Start

March 1, 2013

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2031

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

NL(1)