Lung CancerNCT01888692
To Evaluate the Impact of PET/CT on Radiation Treatment Planning in Relation to Changes in GTV in Stage 3 NSCLC
An observational study of Lung Cancer, run by University of Manitoba at 1 site in Canada.
Trial summary
Acknowledging that level I evidence already exists regarding the general beneficial impact on FDG PET in the staging and subsequent management of lung cancer the investigators postulate that fusing PET/CT data sets with RT CT simulation data sets for adult patients with conventionally/clinically assessed stage III… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2007to Dec 2010
- 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: Pathologically proven NSCLC Clinical stage III A (inoperable) or stage IIIB where there is intent to pursue radical curative RT/chemo, staged with conventional imaging as outlined in standard work up section
Who may be able to join
- Patients must be eligible for the Oncology FDG PET Winnipeg PET Program/Edmonton Cross Cancer Institute Extended Phase III Clinical Trial - Protocol 001, and in addition;
- Pathologically proven NSCLC
- Clinical stage III A (inoperable) or stage IIIB where there is intent to pursue radical curative RT/chemo, staged with conventional imaging as outlined in standard work up section.
- ECOG Performance status 0-2
- Age ≥ 18 years
- FEV1 ≥ 1.0 L
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- No prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for one year or more for non primary bronchogenic cancers and two years for primary bronchogencic cancers;
- No prior RT to thorax.
- Must be able to start RT within 4 weeks after PET/CT simulation
- Participants may be treated with radical radiation only or without concurrent chemotherapy, adjuvant chemotherapy or neo-adjuvant therapy.
Who cannot join
- As per Oncology FDG PET Winnipeg PET Program/Edmonton Cross Cancer Institute Extended Phase III Clinical Trial - Protocol 001 and more specifically:
- Unable/unwilling to give informed consent.
- Uncontrolled hyperglycemia ( Blood sugar> 12 mmol/L)
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Study to Evaluate the Impact of PET/CT Simulation on Radiation Treatment Planning in Relation to Changes in GTV in Locally Advanced Non-small Cell Lung Cancer
Acknowledging that level I evidence already exists regarding the general beneficial impact on FDG PET in the staging and subsequent management of lung cancer the investigators postulate that fusing PET/CT data sets with RT CT simulation data sets for adult patients with conventionally/clinically assessed stage III non-small cell lung cancer will have a significant impact on GTV as well as normal tissue irradiation. This research will also estimate inter and intra-observer variability of treatment planning, relative to GTV, between and amongst radiation oncologists.
Read the detailed description
Primary objectives of the study:
1.To determine the impact of PET/CT fusion on gross tumor volume ( GTV ) for primary(GTVP) and nodal (GTVN) disease for each patient by comparing GTV contours using two separate data sets.
(A) GTVP CT+ ve and GTVN CT+ ve
(B) GTVP PET+ve and GTVN PET +ve
GTV will be measured and recorded in cubic centimeters for each volume.
Secondary Endpoints:
1.Normal tissue toxicity:3D conformal Computerized radiation plans will be generated for the data sets GTVP and GTVN A and B .Dose Volume Histogram (DVH) will be determined and compared for the following normal tissue toxicity parameters.
- V 20 Both lungs (Combined total lung volumes including PTV): Volume of both lungs receiving ≥ 20 G y, including planning target volume.
II. Mean lung dose: Mean radiation dose received by both lungs in a given radiation plan, calculated by the planning computer.
III. V 55 Esophagus: Volume of esophagus receiving≥ 55Gy.
IV. Mean esophageal dose : Mean radiation dose received by whole esophagus in a given radiation plan, calculated by the planning computer
- Spinal cord dose: Maximum dose received by the spinal cord in a given radiation plan.
V1.. V40 Whole heart: Volume of heart receiving ≥ 40Gy
2A Inter observer variation: This will be determined for the data sets GTV A and B only delineated by 4 radiation oncologists blinded to each other, for first 20 patients. The resident involved in this project will be responsible to co-ordinate this part of the project. GTV will be measured and recorded in cubic centimeters for each volume.
2B Intra observer variation: This will be determined for the data sets GTV A and B only delineated by the same radiation oncologist (treating physician) at two different occasions, for first 20 patients. Minimum time interval between the two contours will be one month .The resident involved in this project will be responsible to co-ordinate this part of the project. GTV will be measured and recorded in cubic centimeters for each volume.
- Conditions
- Lung Cancer
- Keywords
- PET/CT, Radiotherapy, Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of PET/CT fusion on gross tumor volume for primary and nodal disease for each patient by comparing GTV contours using three separate data sets.
Measured: From April 2007 -upto two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startApr 2007
- Primary completionAug 2009
- Study completionDec 2010
Why it stopped: Poor accural
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naseer Ahmed, MD, Study director, CancerCare Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888692
- Sponsor's protocol ID
- B2006;089
- Status last verified
- Jun 2013
- First submitted
- 18 Jun 2013
- Last updated
- 28 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Evaluate the Impact of PET/CT Simulation on Radiation Treatment Planning in Relation to Changes in GTV in Locally Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01888692
- Acronym / sponsor ID
- B2006;089
- Conditions
- Lung Cancer
- Keywords
- PET/CT, Radiotherapy, Lung Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor accural
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Jun 2013 (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.
Acknowledging that level I evidence already exists regarding the general beneficial impact on FDG PET in the staging and subsequent management of lung cancer the investigators postulate that fusing PET/CT data sets with RT CT simulation data sets for adult patients with conventionally/clinically assessed stage III non-small cell lung cancer will have a significant impact on GTV as well as normal tissue irradiation. This research will also estimate inter and intra-observer variability of treatment planning, relative to GTV, between and amongst radiation oncologists.
Detailed description
Primary objectives of the study:
1.To determine the impact of PET/CT fusion on gross tumor volume ( GTV ) for primary(GTVP) and nodal (GTVN) disease for each patient by comparing GTV contours using two separate data sets.
(A) GTVP CT+ ve and GTVN CT+ ve
(B) GTVP PET+ve and GTVN PET +ve
GTV will be measured and recorded in cubic centimeters for each volume.
Secondary Endpoints:
1.Normal tissue toxicity:3D conformal Computerized radiation plans will be generated for the data sets GTVP and GTVN A and B .Dose Volume Histogram (DVH) will be determined and compared for the following normal tissue toxicity parameters.
- V 20 Both lungs (Combined total lung volumes including PTV): Volume of both lungs receiving ≥ 20 G y, including planning target volume.
II. Mean lung dose: Mean radiation dose received by both lungs in a given radiation plan, calculated by the planning computer.
III. V 55 Esophagus: Volume of esophagus receiving≥ 55Gy.
IV. Mean esophageal dose : Mean radiation dose received by whole esophagus in a given radiation plan, calculated by the planning computer
- Spinal cord dose: Maximum dose received by the spinal cord in a given radiation plan.
V1.. V40 Whole heart: Volume of heart receiving ≥ 40Gy
2A Inter observer variation: This will be determined for the data sets GTV A and B only delineated by 4 radiation oncologists blinded to each other, for first 20 patients. The resident involved in this project will be responsible to co-ordinate this part of the project. GTV will be measured and recorded in cubic centimeters for each volume.
2B Intra observer variation: This will be determined for the data sets GTV A and B only delineated by the same radiation oncologist (treating physician) at two different occasions, for first 20 patients. Minimum time interval between the two contours will be one month .The resident involved in this project will be responsible to co-ordinate this part of the project. GTV will be measured and recorded in cubic centimeters for each volume.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pathologically proven NSCLC Clinical stage III A (inoperable) or stage IIIB where there is intent to pursue radical curative RT/chemo, staged with conventional imaging as outlined in standard work up section
Key inclusion criteria (10 listed)
- Patients must be eligible for the Oncology FDG PET Winnipeg PET Program/Edmonton Cross Cancer Institute Extended Phase III Clinical Trial - Protocol 001, and in addition;
- Pathologically proven NSCLC
- Clinical stage III A (inoperable) or stage IIIB where there is intent to pursue radical curative RT/chemo, staged with conventional imaging as outlined in standard work up section.
- ECOG Performance status 0-2
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- As per Oncology FDG PET Winnipeg PET Program/Edmonton Cross Cancer Institute Extended Phase III Clinical Trial - Protocol 001 and more specifically:
- Unable/unwilling to give informed consent.
- Uncontrolled hyperglycemia ( Blood sugar> 12 mmol/L)
- Pregnant or lactating females
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
Impact of PET/CT fusion on gross tumor volume for primary and nodal disease for each patient by comparing GTV contours using three separate data sets.
Time frame: From April 2007 -upto two years
Results and safety
The study was stopped early (reason given: Poor accural). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
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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.
Naseer Ahmed, MD study director
CancerCare Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by University of Manitoba at 1 site 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 10 inclusion and 4 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: stopped early, as of the sponsor's last update on 28 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was stopped early (reason given: Poor accural). Results are not available in the source record.
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?
Impact of PET/CT fusion on gross tumor volume for primary and nodal disease for each patient by comparing GTV contours using three separate data sets. (time frame: From April 2007 -upto two 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 28 Jun 2013.