Non-small-cell Lung Cancer Clinical Trial
Official title:
Role of SPECT in Radiotherapy Treatment Planning and Toxicity Evaluation for the Patients With Stage I-III NSCLC
NCT number | NCT01745484 |
Other study ID # | KFE-1203 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2012 |
Est. completion date | July 2015 |
Verified date | April 2019 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Overall objective of the study is to compare the use of SPECT in radiotherapy treatment planning with standard CT-based radiotherapy for stage I-III non-small-cell lung cancer patients
Status | Completed |
Enrollment | 71 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Stage I-III non-small cell lung cancer, histologically verified - Referred for definitive radiotherapy to the Department of Oncology, Aarhus University Hospital - Meet the criteria for curatively intended radiotherapy described in details in the national guidelines - Concurrent chemotherapy is accepted - Adults over 18, that have given oral and written informed consent before patient registration - The patients can only be randomized in this trial once Exclusion Criteria: - other uncontrolled malignancies - human albumin allergy - any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Oncology, Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Grade 2 radiation pneumonitis | The primary endpoint is grade 2 pneumonitis, defined according to the NCI Common Toxicity Criteria for Adverse Events (CTC) version 4.0. Estimation of the occurrence of pulmonary tissue effects: Number of patients developing pulmonary toxicity over grade 2 in both treatment arms according to the Common Terminology Criteria for Adverse Events CTC v. 4.0 and measured serially from 0 to 12 months after radiotherapy, as well as according to the SOMA-LENT scale measured serially from 0 to 12 months after radiotherapy |
measured 0-12 months after completed radiotherapy | |
Secondary | Overall quality of life score | Change in quality of life according to the standard quality of life questionnaires | 0-12 months after radiotherapy | |
Secondary | Mean lung dose (MLD) and V5-50(volume of the lung receiving 5-50 Gy or more) | Estimation of conventional (from CT alone) and functional (from SPECT)dose-volume parameters (MLD and V5-50) and their correlation with pulmonary toxicity will be done. | 12 months after radiotherapy | |
Secondary | Progression-free survival | Proportion of patients alive with no evidence of disease as per the RECIST criteria in the SPECT arm compared to CT arm | at 12 months after radiotherapy |
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