Time Trends in Waiting Times of NSCLC Patients.

NCT01946490 | Withdrawn

• 1 other identifier: Waiting Times
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A large group of non-small cell lung cancer patients is treated with radiotherapy. Delivery of very high radiation doses is needed to obtain local control, but due to the large tumor and nodal volume this is often impossible without causing unrepairable damage to the normal tissue of the mediastinum, spinal cord, esophagus and lung. Although every tumor is different with respect to the speed with which it grows and spreads, it is obvious that time plays an important role in cancer therapy. Recently it was reported that disease progression or increase of tumor volume occurred during the time interval between diagnosis and treatment.(1, 2) This could lead to a less optimal radiation treatment and consequently have an impact on overall survival. Moreover, the increasing number of diagnostic procedures, aimed at obtaining more accurate information about the tumor extension and biology, as well as the use of more sophisticated but labor intense radiation techniques could prolong the time interval between clinical symptoms and the start of the treatment. However, the influence of new diagnostic procedures or the applied radiotherapy techniques on waiting times is not yet known. The investigators therefore want to investigate 1) time trends in the waiting time for NSCLC patients, 2) the correlation between waiting times and the use of more advanced diagnostic or therapeutic procedures, and 3) the correlation between waiting times and overall survival. The hypotheses of the study:

1. 1.The diagnostic delay for NSCLC patients has increased during the last 12 years.
2. 2.The preparation time for radiotherapy of NSCLC patients has increased during the last 12 years.
3. 3.Prolonged waiting times are associated with worse overall survival outcome.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Analysis of waiting times

  Retrospective analysis of the time passed between consultation and start of radiotherapy (an expected average time frame of two weeks).

  From intake to start of radiotherapy

• Correlation of waiting times and treatment outcome

  Is there a correlation between the time passed between consultation and start of radiotherapy and treatment outcome? (Time frame: 12 years)

  From treatment until date of censoring (12 years)

Study Arms (4)

Radiotherapy in 2001

Radiotherapy in 2004

Radiotherapy in 2006

Radiotherapy in 2010

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Four cohorts of NSCLC patients will be analyzed. Patients were all treated with radiotherapy with or without chemotherapy. To investigate the time trends, cohorts referred for radiotherapy treatment in 2001, 2004, 2006 and 2010 will be analyzed.

You may qualify if:

• Patients with NSCLC treated in the Dutch province Limburg from 2001 onwards.

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• Comprehensive Cancer Centre The Netherlands: collaborator

Study Sites (1)

MAASTRO clinic

Maastricht, Limburg, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 19, 2013
• Study Start: December 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 30, 2015

Record last verified: 2015-09

Locations

NL (1)