SDC for Lung Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation

Lung Cancer Clinical Trial

— SDC lung  

Official title:

Standardized Data Collection (SDC) for Lung Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation (SDC Lung).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855191
• Other study ID #: SDC Lung
• Status: Completed
• Start date: June 2013
• Est. completion date: February 2019

Study information

• Verified date: March 2019
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Introducing standardized data collection (SDC) for lung cancer patients to improve the performance of the prediction models.

Description:

All patients planned for curative primary or postoperative radiotherapy can be included. Patients will be treated according to the institutional protocol. It is optional to collect a saliva sample for genetic profiling.

Follow up at five time points:

• 2 weeks after RT

• 3 months after RT

• 6 months after RT

• 12 months after RT

• 24 months after RT

At these time points, toxicity will be assessed. In addition, patients will receive a short questionnaire by mail at eight time points.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 864
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients planned for curatively intended radiotherapy or postoperative radiotherapy

• Recurrent disease

Exclusion Criteria:

• All patients planned for palliative radiotherapy

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Netherlands	MAASTRO clinic	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two-year survival rate		24 months after RT
Secondary	Change in dyspnea		during 24 months after RT
Secondary	Change in cough		During 24 months after RT
Secondary	Change in dysphagia		During 24 months after RT
Secondary	Patient-rated generic quality of life	Measured by Euroqol questionnaire	During 24 months after RT