Lung CancerNCT00732563
Fludeoxyglucose F 18 in Detecting Lymph Node Metastasis in Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed by Surgery
A study testing chemotherapy, lymphadenectomy and neoadjuvant therapy in people with Lung Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Diagnostic procedures using fludeoxyglucose F 18 and a surgical probe may help find lymph node metastases in patients with early-stage non-small cell lung cancer. PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 works in detecting lymph node metastasis in patients with stage I or stage… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- chemotherapy, lymphadenectomy and neoadjuvant therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2008to 26 Jul 2017
- Phase
- Interventional
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of non-small cell lung cancer
- Stage I-II disease
- Resectable disease
- Planning to undergo surgical resection
- No tumors that are not fludeoxyglucose F 18 (FDG)-avid on PET scan
PATIENT CHARACTERISTICS:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No previous allergic reaction to fludeoxyglucose F 18
- No contraindication to a pulmonary lobectomy and lymphadenectomy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: Radioguided Detection of Lymph Node Metastasis in Non-Small Cell Lung Cancer
RATIONALE: Diagnostic procedures using fludeoxyglucose F 18 and a surgical probe may help find lymph node metastases in patients with early-stage non-small cell lung cancer.
PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 works in detecting lymph node metastasis in patients with stage I or stage II non-small cell lung cancer that can be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- Determine the positive threshold of lymph node radioactivity after fludeoxyglucose F 18, utilizing the gamma probe, in patients with resectable stage I or II non-small cell lung cancer.
- Compare the accuracy of detecting thoracic lymph node metastases using positron emission tomography-computed tomography (PET-CT) versus the intra-operative hand-held gamma probe in these patients.
- Determine the ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging in these patients.
- Assess the clinical relevance of the gamma probe-detected lymph node metastases by measuring patient survival, tumor recurrence, impact on patient quality of life, and cost.
OUTLINE: Patients undergo a positron emission tomography-computed tomography (PET-CT) scan within 90 days before surgery. Beginning 1-4 hours before surgery on day 1, patients receive an injection of fludeoxyglucose F 18 (FDG) and a mediastinoscopy is performed. FDG-avid lymph nodes are obtained and may undergo immunohistochemical analysis or standard analysis. Patients with mediastinal lymph node micrometastasis do not undergo primary tumor resection. Patients with ipsilateral mediastinal micrometastases undergo neoadjuvant chemotherapy prior to surgical resection. Patients with contralateral mediastinal micrometastases undergo definitive chemoradiotherapy. In the absence of mediastinal lymph node metastases (micro or macro), complete surgical resection is performed after the mediastinoscopy, including complete thoracic lymphadenectomy. The tumor and lymph nodes (both from mediastinoscopy and thoracotomy) undergo radioactivity measurements with the hand-held gamma probe. Fresh tumor and lymph node samples are stored for future studies.
Patients complete the Short Form 36 Health Survey (SF-36) before surgery and at 1, 3, and 6 months after surgery to assess the potential impact of the gamma probe on patient quality of life.
After completion of study, patients are followed every 6 months for 2 years, and then annually for 3 years.
- Conditions
- Lung Cancer
- Being tested
- chemotherapy, lymphadenectomy, neoadjuvant therapy, quality-of-life assessment, therapeutic conventional surgery
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapyDrug
Given IV and Orally
lymphadenectomyProcedure or surgery
Removal of lymph nodes
neoadjuvant therapyProcedure or surgery
Tumor reduction
quality-of-life assessmentProcedure or surgery
Correlative Study
therapeutic conventional surgeryProcedure or surgery
Treatment for cancer
thoracic surgical procedureProcedure or surgery
removal of tissue
fludeoxyglucose F 18Radiation
given IV
radiation therapyRadiation
undergoing radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate at 2 years
Measured: 2 years
Recurrence rate at 2 years
Measured: 2 years
Secondary outcomes (4)
Positive threshold of lymph node radioactivity
Measured: within 90 days
Comparison of the accuracy of detecting thoracic lymph node metastases using PET-CT scans versus intra-operative hand-held gamma probe
Measured: Within 90 days
Ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging
Measured: Within 90 days
Quality of life
Measured: At 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study start16 Jul 2008
- Primary completion29 Jun 2012
- Study completion26 Jul 2017
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 Roswell Park 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chukwumere E. Nwogu, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732563
- Sponsor's protocol ID
- CDR0000601525
- Other IDs
- RPCI-I-97306
- Status last verified
- Oct 2017
- First submitted
- 9 Aug 2008
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioguided Detection of Lymph Node Metastasis in Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00732563
- Acronym / sponsor ID
- CDR0000601525
- Conditions
- Lung Cancer
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 16 Jul 2008 (actual)
- Primary completion
- 29 Jun 2012 (actual)
- Study completion
- 26 Jul 2017 (actual)
- First posted
- 12 Aug 2008 (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.
RATIONALE: Diagnostic procedures using fludeoxyglucose F 18 and a surgical probe may help find lymph node metastases in patients with early-stage non-small cell lung cancer.
PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 works in detecting lymph node metastasis in patients with stage I or stage II non-small cell lung cancer that can be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- Determine the positive threshold of lymph node radioactivity after fludeoxyglucose F 18, utilizing the gamma probe, in patients with resectable stage I or II non-small cell lung cancer.
- Compare the accuracy of detecting thoracic lymph node metastases using positron emission tomography-computed tomography (PET-CT) versus the intra-operative hand-held gamma probe in these patients.
- Determine the ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging in these patients.
- Assess the clinical relevance of the gamma probe-detected lymph node metastases by measuring patient survival, tumor recurrence, impact on patient quality of life, and cost.
OUTLINE: Patients undergo a positron emission tomography-computed tomography (PET-CT) scan within 90 days before surgery. Beginning 1-4 hours before surgery on day 1, patients receive an injection of fludeoxyglucose F 18 (FDG) and a mediastinoscopy is performed. FDG-avid lymph nodes are obtained and may undergo immunohistochemical analysis or standard analysis. Patients with mediastinal lymph node micrometastasis do not undergo primary tumor resection. Patients with ipsilateral mediastinal micrometastases undergo neoadjuvant chemotherapy prior to surgical resection. Patients with contralateral mediastinal micrometastases undergo definitive chemoradiotherapy. In the absence of mediastinal lymph node metastases (micro or macro), complete surgical resection is performed after the mediastinoscopy, including complete thoracic lymphadenectomy. The tumor and lymph nodes (both from mediastinoscopy and thoracotomy) undergo radioactivity measurements with the hand-held gamma probe. Fresh tumor and lymph node samples are stored for future studies.
Patients complete the Short Form 36 Health Survey (SF-36) before surgery and at 1, 3, and 6 months after surgery to assess the potential impact of the gamma probe on patient quality of life.
After completion of study, patients are followed every 6 months for 2 years, and then annually for 3 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| chemotherapyGiven IV and Orally | Drug | – |
| lymphadenectomyRemoval of lymph nodes | Procedure or surgery | – |
| neoadjuvant therapyTumor reduction | Procedure or surgery | – |
| quality-of-life assessmentCorrelative Study | Procedure or surgery | – |
| therapeutic conventional surgeryTreatment for cancer | Procedure or surgery | – |
| thoracic surgical procedureremoval of tissue | Procedure or surgery | – |
| fludeoxyglucose F 18given IV | Radiation | – |
| radiation therapyundergoing radiotherapy | Radiation | – |
Primary outcome
Survival rate at 2 years
Time frame: 2 years
Recurrence rate at 2 years
Time frame: 2 years
4 secondary outcomes
Positive threshold of lymph node radioactivity
Time frame: within 90 days
Comparison of the accuracy of detecting thoracic lymph node metastases using PET-CT scans versus intra-operative hand-held gamma probe
Time frame: Within 90 days
Ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging
Time frame: Within 90 days
Quality of life
Time frame: At 3 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 Oct 2017.
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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.
Chukwumere E. Nwogu, MD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chemotherapy, lymphadenectomy and neoadjuvant therapy in people with Lung Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Oct 2017. 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 United States. 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 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?
Survival rate at 2 years (time frame: 2 years). The study lists 2 primary outcomes in all. 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 Oct 2017.