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

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ClinicalTrials.gov Identifier: NCT01855191
Recruitment Status : Completed
First Posted : May 16, 2013
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology

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

Condition or disease
Lung Cancer

Detailed 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.


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Study Type : Observational
Actual Enrollment : 864 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Standardized Data Collection (SDC) for Lung Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation (SDC Lung).
Actual Study Start Date : June 2013
Actual Primary Completion Date : February 2019
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort
Standard
Standard + saliva collection



Primary Outcome Measures :
  1. Two-year survival rate [ Time Frame: 24 months after RT ]

Secondary Outcome Measures :
  1. Change in dyspnea [ Time Frame: during 24 months after RT ]
  2. Change in cough [ Time Frame: During 24 months after RT ]
  3. Change in dysphagia [ Time Frame: During 24 months after RT ]
  4. Patient-rated generic quality of life [ Time Frame: During 24 months after RT ]
    Measured by Euroqol questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients planned for curatively intended radiotherapy or postoperative radiotherapy.
Criteria

Inclusion Criteria:

  • All patients planned for curatively intended radiotherapy or postoperative radiotherapy
  • Recurrent disease

Exclusion Criteria:

  • All patients planned for palliative radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855191


Locations
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Netherlands
MAASTRO clinic
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
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Principal Investigator: Dirk De Ruysscher, MD., PhD. Maastro Clinic, The Netherlands

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Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01855191     History of Changes
Other Study ID Numbers: SDC Lung
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases