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An International Study on the Use of PET/CT in Radiotherapy Planning in Low and Middle Income Countries (PERTAIN)

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.
 
ClinicalTrials.gov Identifier: NCT02247713
Recruitment Status : Unknown
Verified September 2014 by The Netherlands Cancer Institute.
Recruitment status was:  Not yet recruiting
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Collaborator:
International Atomic Energy Agency
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Brief Summary:
A part retrospective, part prospective cohort study to assess the difference in 2-year overall survival in patients with stage III NSCLC receiving chemoradiotherapy with curative intent in low and middle income countries before and after a training intervention on the use of PET/CT for radiotherapy treatment planning.

Condition or disease
Non Small Cell Lung Cancer Stage III

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 520 participants
Observational Model: Cohort
Official Title: An International Study on the Use of PET/CT in Radiotherapy Planning in Low and Middle Income Countries
Study Start Date : September 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Retrospective cohort
Participating centers will retrospectively provide demographic, tumor, treatment and follow-up details on at least 25 consecutive patients with stage III NSCLC previously treated with curative intent chemoradiotherapy (concurrent or sequential) in the period between 2010 and 2013.
Prospective cohort
Participating centers will provide prospective data on patients with stage III NSCLC treated with curative intent concurrent chemoradiotherapy. Centers will be asked to include at least 25 consecutive cases following the training intervention and the successful local implementation of PET/CT for RTP in NSCLC.



Primary Outcome Measures :
  1. 2-year overall survival [ Time Frame: the included patients will be followed for a maximum of 2 years ]
    Determine the impact of PET/CT in RTP on 2-year overall survival rates for patients with stage III NSCLC receiving chemoradiotherapy with curative intent. Patients from the retrospective cohort will be selected from the institutional database and were treated between 2010 to 2013. Patients from the prospective cohort will be selected until the end of 2015.


Secondary Outcome Measures :
  1. Observer agreement with expert contours as a measure of the effect of a training intervention on tumor volume delineation [ Time Frame: up to 5 months ]
    Determine the impact of a PET/CT in RTP training intervention on tumor volume delineation for stage III NSCLC radiotherapy. Different parameters are used to determine the observer variation: Dice Index, median surface distances

  2. Baseline PET/CT characteristics as a measure for PET/CT scanner performance [ Time Frame: up to 8 months ]
    Determine the quality of PET/CT scanners. Study baseline PET/CT imaging protocols and image acquisition characteristics with the following parameters: recovery coefficients, spatial resolution measurement, and calibration of SUV determination. All centers will participate in the EARL accreditation programme.



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:   Probability Sample
Study Population
The retrospective cohort study includes at least 250 patientswith stage III NSCLC with curative intent chemoradiotherapy (sequential or concurrent), 125 patients in the first arm (non PET staged) and 125 patients (PET staged) in the second arm. The prospective cohort study includes at least 250 patients (PET staged) receiving concurrent chemoradiotherapy based on PET/CT RTP. In total, we aim to include a number of 519 patients.
Criteria

Inclusion Criteria:

  • pathologically confirmed NSCLC
  • stage III as per local diagnostic protocol or agreement of local multidisciplinary team
  • available for clinical follow-up for at least 2 years
  • suitable for treatment with a radical target volume in the opinion of a radiation oncologist
  • ECOG performance 0 or 1
  • signed informed consent
  • ability to commence radiation therapy within 4 weeks of acquisition of the RTP PET/CT
  • suitable for concurrent chemoradiotherapy (prospective cohort only)

Exclusion Criteria:

  • other neoplasms in the last 5 years except non-melanoma skin cancer
  • stage IV disease diagnosed before acquisition of staging PET/CT
  • inability to provide informed consent
  • uncontrolled diabetes mellitus
  • pregnant or breast feeding mothers
  • tuberculosis
  • neo-adjuvant chemotherapy

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): NCT02247713


Contacts
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Contact: Tom Konert, BSc 0031205127954 t.konert@nki.nl

Sponsors and Collaborators
The Netherlands Cancer Institute
International Atomic Energy Agency
Investigators
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Principal Investigator: Wouter V Vogel, MD Antoni van Leeuwenhoek - Netherlands Cancer Institute
Principal Investigator: Gerard G Hanna, MD Centre for Cancer Research and Cell Biology, Queen's University Belfast

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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT02247713    
Other Study ID Numbers: M14PRI
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Keywords provided by The Netherlands Cancer Institute:
PET
radiotherapy
international
NSCLC
overall survival
low and middle income countries
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases