Non-Small-Cell Lung CarcinomaPhase 3NCT00136864
Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer (PET START Trial)
A Phase 3 study testing PET Diagnostic Imaging in people with Non-Small-Cell Lung Carcinoma, run by Ontario Clinical Oncology Group (OCOG) at 5 sites in Canada.
Trial summary
Locally advanced non-small cell lung cancer, NSCLC, (Stage III) is potentially curable with aggressive combined modality therapy (chemotherapy and radiation). Conventional imaging can only evaluate gross anatomic abnormalities but functional imaging with positron emission tomography (PET) may more accurately identify… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma
- What is being tested?
- PET Diagnostic Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 5 sitesCanada
- Study dates
- Aug 2004to Sep 2011
- Phase
- Phase 3
- 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
Who may be able to join
- Histological or cytological evidence of NSCLC. Must have documented pathology report with histology indicated (e.g. squamous, adenocarcinoma, large cell, NSCLC not otherwise specified).
- Stage III (mediastinal node positive) NSCLC based on conventional staging (e.g. computed tomography [CT] scan of chest and upper abdomen, CT or magnetic resonance imaging [MRI] of brain, bone scan).
- Suitable for combined modality (chemotherapy and radiation) therapy or radical radiation therapy or trimodality therapy (chemotherapy, radiation and surgery).
Who cannot join
- Stage IV NSCLC (by conventional staging).
- Small cell lung cancer.
- Poor performance status Eastern Cooperative Oncology Group (ECOG) 3-4.
- Poor pulmonary function precluding radical radiation therapy (Adequate pulmonary reserve for radical radiation therapy. Pulmonary function tests should have forced expiratory volume in 1 second (FEV1) > 1.0 liter or > 40% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) > 45% and/or predicted contralateral FEV1 > 800 cc based on quantitative ventilation perfusion lung scan).
- Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease).
- Insulin dependent diabetic where requirements for PET imaging may be problematic.
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- Unable to lie supine for at least 30 minutes in radiation treatment position for imaging with PET.
- Failure to provide informed consent.
- Previous PET scan relating to recent cancer diagnosis prior to entry into study.
- Pregnant or lactating females.
- Prior thoracic radiation.
- Prior malignancy within 3 years from randomization (except nonmelanotic skin cancer or carcinoma in situ of the cervix).
- Administered more than two cycles of chemotherapy prior to radical radiation therapy or concurrent chemoradiation (as part of induction or sequential chemotherapy prior to randomization) for the current malignancy.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
London Regional Cancer Centre
London, Ontario, N6A 4L6
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Toronto-Sunnybrook Odette Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: The Impact of Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer: A Prospective Randomized Clinical Trial (PET START Trial)
Locally advanced non-small cell lung cancer, NSCLC, (Stage III) is potentially curable with aggressive combined modality therapy (chemotherapy and radiation). Conventional imaging can only evaluate gross anatomic abnormalities but functional imaging with positron emission tomography (PET) may more accurately identify patients who will benefit from aggressive combined modality therapy.
This prospective randomized clinical trial will enroll 400 patients that have undergone conventional staging for lung cancer and have been found to have Stage III NSCLC. The patients will then be randomized to either standard combined modality therapy for Stage III NSCLC or to PET imaging prior to combined modality therapy with curative intent. Based on the PET findings, patients will either be suitable for combined modality therapy with curative intent or not.
- Conditions
- Non-Small-Cell Lung Carcinoma
- Being tested
- PET Diagnostic Imaging
- Keywords
- Positron-Emission Tomography, PET Scan, Non-Small-Cell Lung Carcinoma, Diagnosis, Radiation Oncology, Lung Cancer, Randomized Controlled Trial, Oncology, Radiation Planning
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Disease, Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET Diagnostic ImagingProcedure or surgery
Patients in the PET group will undergo the standard diagnostic tests plus PET to determine those suitable for combined modality therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PET Imaging Receives: Procedure: PET Diagnostic Imaging |
| 2 | No intervention | Standard Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage III NSCLC patients upstaged by PET
Measured: 2 years
Secondary outcomes (4)
Overall survival
Measured: 2 years
Impact of PET on radiation treatment planning
Measured: 2 years
Prognostic ability of PET standard uptake value
Measured: 2 years
Number of patients downstaged by PET
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startAug 2004
- Primary completionNov 2009
- Study completionSep 2011
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 CarcinomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Sponsor
- Investigators
- Yee C Ung, MD, Study chair, Toronto Sunnybrook Regional Cancer CentreMark N Levine, MD, Principal investigator, Ontario Clinical Oncology Group (OCOG)William Evans, MD, Principal investigator, Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136864
- Sponsor's protocol ID
- CTA-Control-087276
- Status last verified
- Nov 2011
- First submitted
- 25 Aug 2005
- Last updated
- 18 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer: A Prospective Randomized Clinical Trial (PET START Trial)
- ClinicalTrials.gov ID
- NCT00136864
- Acronym / sponsor ID
- CTA-Control-087276
- Conditions
- Non-Small-Cell Lung Carcinoma
- Keywords
- Positron-Emission Tomography, PET Scan, Non-Small-Cell Lung Carcinoma, Diagnosis, Radiation Oncology, Lung Cancer, Randomized Controlled Trial, Oncology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- Aug 2004
- Primary completion
- Nov 2009 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 29 Aug 2005 (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.
Locally advanced non-small cell lung cancer, NSCLC, (Stage III) is potentially curable with aggressive combined modality therapy (chemotherapy and radiation). Conventional imaging can only evaluate gross anatomic abnormalities but functional imaging with positron emission tomography (PET) may more accurately identify patients who will benefit from aggressive combined modality therapy.
This prospective randomized clinical trial will enroll 400 patients that have undergone conventional staging for lung cancer and have been found to have Stage III NSCLC. The patients will then be randomized to either standard combined modality therapy for Stage III NSCLC or to PET imaging prior to combined modality therapy with curative intent. Based on the PET findings, patients will either be suitable for combined modality therapy with curative intent or not.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: PET Diagnostic ImagingPET Imaging |
| 2 | No intervention | –Standard Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histological or cytological evidence of NSCLC. Must have documented pathology report with histology indicated (e.g. squamous, adenocarcinoma, large cell, NSCLC not otherwise specified).
- Stage III (mediastinal node positive) NSCLC based on conventional staging (e.g. computed tomography [CT] scan of chest and upper abdomen, CT or magnetic resonance imaging [MRI] of brain, bone scan).
- Suitable for combined modality (chemotherapy and radiation) therapy or radical radiation therapy or trimodality therapy (chemotherapy, radiation and surgery).
Key exclusion criteria (13 listed)
- Stage IV NSCLC (by conventional staging).
- Small cell lung cancer.
- Poor performance status Eastern Cooperative Oncology Group (ECOG) 3-4.
- Poor pulmonary function precluding radical radiation therapy (Adequate pulmonary reserve for radical radiation therapy. Pulmonary function tests should have forced expiratory volume in 1 second (FEV1) > 1.0 liter or > 40% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) > 45% and/or predicted contralateral FEV1 > 800 cc based on quantitative ventilation perfusion lung scan).
- Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET Diagnostic ImagingPatients in the PET group will undergo the standard diagnostic tests plus PET to determine those suitable for combined modality therapy | Procedure or surgery | 1 |
Primary outcome
Stage III NSCLC patients upstaged by PET
Time frame: 2 years
4 secondary outcomes
Overall survival
Time frame: 2 years
Impact of PET on radiation treatment planning
Time frame: 2 years
Prognostic ability of PET standard uptake value
Time frame: 2 years
Number of patients downstaged by PET
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2011.
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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.
Yee C Ung, MD study chair
Toronto Sunnybrook Regional Cancer Centre
Mark N Levine, MD principal investigator
Ontario Clinical Oncology Group (OCOG)
William Evans, MD principal investigator
Juravinski Cancer Centre
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PET Diagnostic Imaging in people with Non-Small-Cell Lung Carcinoma, run by Ontario Clinical Oncology Group (OCOG) at 5 sites in Canada.
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 3 inclusion and 13 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: finished, as of the sponsor's last update on 18 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage III NSCLC patients upstaged by PET (time frame: 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 18 Nov 2011.