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Non Small Cell Lung Cancer Stage IIIPERTAINNCT02247713

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

An observational study of Non Small Cell Lung Cancer Stage III, run by The Netherlands Cancer Institute.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer Stage III
How many people
520 participants
Where
No sites listed yet
Study dates
Sep 2014to Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Tom Konert, BSc contact

0031205127954

t.konert@nki.nl

About this study

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.

Read the detailed description

Over the years, the incidence of lung cancer has risen in some low and middle income countries due to the rise in tobacco use. Patients commonly present with lung cancer in an advanced stage (stage III and IV) are not suitable for surgical resection, but may be considered for radiotherapy. For patients in those countries who are not suitable for surgical resection, radiotherapy offers the best chance of cure, best improvement in local cancer control, best palliation and fewest side-effects. For accurate patient selection for curative treatment and accurate staging of lung cancer, the use of fused 18F-fluorodeoxyglucose Positron Emission Tomography/ Computed Tomography (FDG PET/CT) imaging has been shown to be superior to CT alone. It has also been shown to have a significant impact when used in the radiation treatment planning process and in particular for when used for target volume delineation, where a significant reduction in interobserver variation has been noted.

In recent years, many health care institutions in low and middle income countries have established Nuclear Medicine (NM) imaging in routine clinical practice in conjunction with modern Radiation Oncology (RO) facilities. The installation of hybrid PET/CT systems in these countries permits more the increased use of PET/CT for both staging and radiotherapy planning. However the successful implementation of PET/CT for radiotherapy planning (RTP) requires a degree of expertise to safely and accurately implement this imaging technique. A recently published review by the International Atomic Energy Agency (IAEA), about current trends in NM in developing countries showed there is still lack of expertise, equipment and human resources to gain benefit from this imaging technique. In RO, difficulties in the implementation of this technique are mainly related to inadequate training of staff and lack of local expertise.

Quality assurance of the PET/CT scanners might be compromised when not performed according to accepted nuclear medicine quality assurance standards. Therefore, there is a concern that, if used without appropriate training or expertise, suboptimal image quality may result and inappropriate interpretation of the PET/CT for RTP may occur. In this study to help provide PET Quality Control will be executed to aim for a standardized PET image quality that meets the minimum requirements of European Association of Nuclear Medicine standards. Participating centers will be assisted to earn the European Association of Nuclear Medicine (EANM) Research Ltd (EARL) accreditation. The quality of the imaging can be influenced by physiological and technical factors. The Standardized Uptake Value (SUV) allows for semi quantitative evaluation in PET imaging, and is influenced by these factors. Spatial resolution affects SUV values significantly and this parameter can differ a lot between multiple centers. The EANM NEMA NU 2001/2007 2 Image Quality Phantom allows for standardization of PET imaging between centers with different scanners, using the activity coefficient recovery curve (ACRC) as a parameter for quantification of this spatial resolution.

It is already known that FDG PET/CT based RTP enables appropriate selection of patients who will benefit from curative radiation therapy. One possible cause of failure in radiotherapy is the inability to accurately define the tumor edges. In these patients there are no other possible curative salvage treatment options and the disease is incurable. It is hoped that FDG PET/CT based RTP will improve tumor volume delineation (TVD) and hence improve outcomes following curative radiotherapy. There is also clear evidence that PET/CT standardizes TVD in patients with NSCLC. However, what is not known is the impact of PET/CT based TVD on patient outcomes such as survival as distinct from the benefit of PET/CT for patient selection for curative treatment. Furthermore, the impact of a training intervention on the use of PET/CT RTP in 2-year overall survival has not been studied to the best of our knowledge.

This study will evaluate the possible impact of the use of PET/CT for TVD on 2-year overall survival in patients with stage III NSCLC referred for curative intent radiotherapy with chemotherapy in low and middle income countries, this study involves a retrospective cohort study, a training intervention, and a prospective cohort study. The training intervention will focus on standard FDG PET/CT acquisition, FDG PET/CT image quality, staging procedure for FDG PET/CT acquisition and FDG PET/CT for RTP acquisition and Tumor Volume Delineation.

Keywords
PET, radiotherapy, international, NSCLC, overall survival, low and middle income countries
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02247713
Study groupRoleWhat they receive
Retrospective cohortParticipating 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 cohortParticipating 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-year overall survival

    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.

    Measured: the included patients will be followed for a maximum of 2 years

Secondary outcomes (2)
  1. Observer agreement with expert contours as a measure of the effect of a training intervention on tumor volume delineation

    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

    Measured: up to 5 months

  2. Baseline PET/CT characteristics as a measure for PET/CT scanner performance

    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.

    Measured: up to 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionDec 2015 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Enrolment
520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02247713
Sponsor's protocol ID
M14PRI
Acronym
PERTAIN
Status last verified
Sep 2014
First submitted
14 Aug 2014
Last updated
25 Sep 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Non Small Cell Lung Cancer Stage III, run by The Netherlands Cancer Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tom Konert, BSc (0031205127954, t.konert@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year overall survival (time frame: the included patients will be followed for a maximum of 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014; AzTrials last refreshed its copy on 7 Nov 2026.

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