Time Trends in Waiting Times of NSCLC Patients.

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Time Trends in Diagnostic Delay and Waiting Times of Four Patient Cohorts, Diagnosed With Non-small Cell Lung Cancer, Treated With High Dose Radiotherapy.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01946490
• Other study ID #: Waiting Times
• Status: Withdrawn
• Phase: N/A
• First received: September 3, 2013
• Last updated: September 29, 2015
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2015
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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. The diagnostic delay for NSCLC patients has increased during the last 12 years.

2. The preparation time for radiotherapy of NSCLC patients has increased during the last 12 years.

3. Prolonged waiting times are associated with worse overall survival outcome.

Description:

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. The diagnostic delay for NSCLC patients has increased during the last 12 years.

2. The preparation time for radiotherapy of NSCLC patients has increased during the last 12 years.

3. Prolonged waiting times are associated with worse overall survival outcome.

The IKL collected data on waiting times and treatment of NSCLC patients treated in 2001 and 2004. These data will be used for this project. In addition, the MAASTRO lung database contains information of patients treated in 2006 and 2010. Additional information about the diagnostic procedure and radiation treatment preparation will be collected by reviewing the patient charts. For this study a data request has to be submitted to the IKL and access to MAASTRO patient data (charts and EMD) is needed.

The investigators aim to collect the following variables: Date of consultation pulmonologist; Date of multidisciplinary meeting; Date of first consultancy at radiotherapy; Date of start radiotherapy; Information about diagnostic procedure (PET/CT/Pathology/EBUS/EUS); Information about RT procedure (3Dconventional/IMRT); General patient characteristics; Overall survival

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
Netherlands	MAASTRO clinic	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology	IKNL

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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)	No