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Role of SPECT in Radiotherapy of Lung Cancer and Toxicity Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01745484
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : April 25, 2019
Information provided by (Responsible Party):
Katherina Farr, University of Aarhus

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Non-small-cell Lung Cancer Radiation Pneumonitis Other: SPECT-based treatment plan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of SPECT in Radiotherapy Treatment Planning and Toxicity Evaluation for the Patients With Stage I-III NSCLC
Study Start Date : June 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1
SPECT scan will be performed at baseline. Patients will receive radiotherapy according to standard CT-based plan with conventional dose-volume histogram
Other: SPECT-based treatment plan

SPECT will be performed on all patients at baseline. Two treatment plans will be made- functional SPECT-based plan and conventional CT-based plan. Randomization will take place if both plans are satisfying established criteria for tumour coverage and normal tissue sparing. Randomization between Arm 1 and Arm 2 will be done, where the patients will be treated either by SPECT-plan or by CT-plan respectively.

The SPECT data are viewed as a multicoloured image in the spectrum colour setting to allow accurate volume contouring around a predefined colour. The threshold level is adjusted individually for each patient in order to match the size of the SPECT image within the lung volumes defined on CT. A new contour of functional lung is created from the SPECT images using a threshold of 30% of the maximum uptake for each patient. A treatment plan is generated. The principal objective for each plan is to minimize the volume of lungirradiated

Other Name: Single Photon Emission Computed Tomography

Primary Outcome Measures :
  1. Grade 2 radiation pneumonitis [ Time Frame: measured 0-12 months after completed radiotherapy ]

    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

Secondary Outcome Measures :
  1. Overall quality of life score [ Time Frame: 0-12 months after radiotherapy ]
    Change in quality of life according to the standard quality of life questionnaires

  2. Mean lung dose (MLD) and V5-50(volume of the lung receiving 5-50 Gy or more) [ Time Frame: 12 months after radiotherapy ]
    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.

  3. Progression-free survival [ Time Frame: at 12 months after radiotherapy ]
    Proportion of patients alive with no evidence of disease as per the RECIST criteria in the SPECT arm compared to CT arm

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

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

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 identifier (NCT number): NCT01745484

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Department of Oncology, Aarhus University Hospital
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
University of Aarhus
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Principal Investigator: Katherina Farr, MD Department of Oncology, Aarhus University Hospital
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Responsible Party: Katherina Farr, Principle Investigator, University of Aarhus Identifier: NCT01745484    
Other Study ID Numbers: KFE-1203
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Keywords provided by Katherina Farr, University of Aarhus:
Non-small-cell lung cancer
Definitive Radiotherapy
Radiation pneumonitis
Randomized study
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Radiation Pneumonitis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Infections
Lung Diseases, Interstitial
Lung Injury
Radiation Injuries
Wounds and Injuries