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.
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.
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.
- Conditions
- Non Small Cell Lung Cancer Stage III
- 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 group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted25 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer Stage IIIStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- International Atomic Energy Agency
- Responsible party
- Sponsor
- Investigators
- Wouter V Vogel, MD, Principal investigator, Antoni van Leeuwenhoek - Netherlands Cancer InstituteGerard G Hanna, MD, Principal investigator, Centre for Cancer Research and Cell Biology, Queen's University Belfast
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Study on the Use of PET/CT in Radiotherapy Planning in Low and Middle Income Countries
- ClinicalTrials.gov ID
- NCT02247713
- Acronym / sponsor ID
- PERTAIN / M14PRI
- Conditions
- Non Small Cell Lung Cancer Stage III
- Keywords
- PET, radiotherapy, international, NSCLC, overall survival, low and middle income countries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- International Atomic Energy Agency
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
Baseline PET/CT characteristics as a measure for PET/CT scanner performance
Time frame: up to 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wouter V Vogel, MD principal investigator
Antoni van Leeuwenhoek - Netherlands Cancer Institute
Gerard G Hanna, MD principal investigator
Centre for Cancer Research and Cell Biology, Queen's University Belfast
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.