NCT02428049

Brief Summary

Aims:

  1. 1.Evaluate changes in lung function before and after radiotherapy for patients with NSCLC in stage I-III receiving curatively intended radiotherapy
  2. 2.To assess the predictive value of pulmonary function tests for the development of radiation pneumonitis after curative radiotherapy
  3. 3.To assess biomarkers in blood samples before, during, and after radiotherapy and correlate to the development of radiation pneumonitis
  4. 4.Investigate survival

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

October 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

5.2 years

First QC Date

April 15, 2015

Last Update Submit

January 19, 2023

Conditions

Lung CancerRadiotherapyLung Function Changes

Outcome Measures

Primary Outcomes (1)

  • permanently reduced lung function

    2 years

Secondary Outcomes (1)

  • predictive value of pulmonary function tests for the development of a permanent reduction in lung function after curative radiotherapy

    2 years

Other Outcomes (1)

  • predictive value of genetic markers for permanently reduced lung function after curative radiotherapy

    2 years

Study Arms (1)

Lung cancer patients

Lung cancer patients in stages IA-IIIA destined to have stereotactic radiotherapy or conventional radiotherapy and chemotherapy in curative intent

Radiation: Stereotactic or conventional radiotherapy and chemotherapy in curative intent

Interventions

Stereotactic or conventional radiotherapy and chemotherapy in curative intentRADIATION
Lung cancer patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

lung cancer patients in stages IA-IIIA

You may qualify if:

  • Age \> 18 years old
  • Current lung cancer, not older than 8 weeks
  • Received written consent
  • Non small cell lung cancer
  • Stage IA-IIIA
  • Inoperable

You may not qualify if:

  • Lack of consent
  • Operable
  • Additional cancer disease
  • Small cell lung carcinoma or neuroendocrine lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestfold Hospital Trust

Tønsberg, 3103, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant

Study Record Dates

First Submitted

April 15, 2015

First Posted

April 28, 2015

Study Start

October 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2025

Last Updated

January 20, 2023

Record last verified: 2023-01

Locations

NO(1)