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Role of SPECT in Radiotherapy of Lung Cancer and Toxicity Evaluation

This study is currently recruiting participants.
Verified December 2012 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
Katherina Farr, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01745484
First received: December 6, 2012
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention
Non-small-cell Lung Cancer
Radiation Pneumonitis
 Other: SPECT-based treatment plan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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: a Randomized Phase II Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Grade 2 radiation pneumonitis [ Time Frame: measured 0-12 months after completed radiotherapy ] [ Designated as safety issue: No ]

    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:
  • quality of life [ Time Frame: 0-12 months after radiotherapy ] [ Designated as safety issue: No ]
    Change in quality of life according to the standard quality of life questionnaires

  • Mean lung dose (MLD) and V5-50(volume of the lung receiving 5-50 Gy or more) [ Time Frame: 12 months after radiotherapy ] [ Designated as safety issue: No ]
    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.

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


Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1

Patients randomized to Arm 1 will be treated by SPECT-based treatment plan with functional dose-volume histogram.

SPECT scan will be performed at baseline

 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
No Intervention: Arm 2
SPECT scan will be performed at baseline. Patients in Arm 2 will receive radiotherapy according to standard CT-based plan with conventional dose-volume histogram

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745484

Contacts
Contact: Katherina Farr, MD +45 30252008 katherina@oncology.dk

Locations
Denmark
Department of Oncology, Aarhus University Hospital Recruiting
Aarhus, Denmark, DK-8000
Contact: Katherina Farr, MD     +45 30252008     katherina@oncology.dk    
Principal Investigator: Katherina Farr, MD            
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Katherina Farr, MD Department of Oncology, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Katherina Farr, Principle Investigator, University of Aarhus
ClinicalTrials.gov Identifier: NCT01745484     History of Changes
Other Study ID Numbers: KFE-1203
Study First Received: December 6, 2012
Last Updated: December 11, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
SPECT
Toxicity
Non-small-cell lung cancer
 Definitive Radiotherapy
Radiation pneumonitis
Randomized study

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Pneumonia
Radiation Pneumonitis
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Interstitial
Lung Injury
Radiation Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013