Lung CancerNCT00089310
Sentinel Lymph Node Mapping in Detecting Cancer That Has Spread to Lymph Nodes in Patients With Non-Small Cell Lung Cancer
A study testing technetium-99 in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 12 sites in United States.
Trial summary
RATIONALE: Diagnostic procedures such as sentinel lymph node mapping may improve the ability to detect cancer that has spread to the lymph nodes. PURPOSE: This clinical trial is studying how well sentinel lymph node mapping works in detecting cancer that has spread to the lymph nodes in patients who are undergoing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- technetium-99
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 12 sitesUnited States
- Study dates
- Sep 2004to Apr 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Patients with clinical stage I lung cancer for whom surgical resection is planned are eligible. Histologic confirmation of lung cancer is not required prior to registration or surgical exploration. Preoperative mediatinoscopy is allowed but not required in those patients with indications for mediatinoscopy. It is preferred that that mediatinoscopy be done at a different setting (prior to registration), but the procedure may be done at the same setting as the lobectomy.
- No prior therapy for this diagnosis.
- No prior treatment with mediastinal radiation therapy.
- Age ≥ 18 years of age.
- ECOG performance status: 0-2.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, 28805
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, 43210-1240
Elmhurst Hospital Center
Elmhurst, New York, 11373
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, 60201-1781
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
Beebe Medical Center
Lewes, Delaware, 19958
Mount Sinai Medical Center
New York, New York, 10029
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043
About this study
Official title: Intraoperative Sentinel Node Mapping In Non-Small Cell Lung Cancer
RATIONALE: Diagnostic procedures such as sentinel lymph node mapping may improve the ability to detect cancer that has spread to the lymph nodes.
PURPOSE: This clinical trial is studying how well sentinel lymph node mapping works in detecting cancer that has spread to the lymph nodes in patients who are undergoing surgery for stage I non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the feasibility and accuracy of intraoperative sentinel lymph node mapping using technetium Tc 99 sulfur colloid in patients with stage I non-small cell lung cancer.
- Determine the percentage of patients in which at least 1 positive sentinel lymph node is identified using this procedure.
- Determine the percentage of patients undergoing this procedure who are found to have positive sentinel lymph nodes with no metastases in other intrathoracic lymph nodes.
Secondary
- Determine the percentage of patients undergoing this procedure whose disease stage is upgraded due to detection of micrometastases in sentinel lymph nodes.
- Correlate the presence of micrometastases in sentinel lymph nodes with survival in patients undergoing this procedure.
- Determine the percentage of patients undergoing this procedure with "skip metastases" pattern (NZ) sentinel lymph nodes.
OUTLINE: This is a multicenter study.
Patients receive an intraoperative intratumoral injection of technetium Tc 99 sulfur colloid. At least 10 minutes later, patients undergo sentinel lymph node mapping using a gamma probe. Patients then undergo sentinel lymph node dissection and tumor resection. Pathology assays are performed using sentinel lymph node tissue, including hematoxylin and eosin staining, serial sections, and immunohistochemistry using the AE1/AE3/PCK2b cytokeratin antibody.
Patients are followed every 6 months for 2 years and then annually thereafter.
- Conditions
- Lung Cancer
- Being tested
- technetium-99
- Keywords
- stage I 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.
technetium-99Radiation
0.25 mCi in 4 equal doses
| Study group | Role | What they receive |
|---|---|---|
| Sentinal node mapping | Experimental | Not described Receives: Radiation: technetium-99 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentinel node identification
Measured: at time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2004 (estimated)
- Study startSep 2004
- Primary completionFeb 2007
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Thomas D'Amico, MD, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089310
- Sponsor's protocol ID
- CALGB-140203
- Other IDs
- U10CA031946, CALGB-140203, CDR0000378197
- Status last verified
- Jun 2016
- First submitted
- 4 Aug 2004
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Liptay MJ, D'amico TA, Nwogu C, Demmy TL, Wang XF, Gu L, Litle VR, Swanson SJ, Kohman LJ; Thoracic Surgery Subcommittee of the Cancer and Leukemia Group B. Intraoperative sentinel node mapping with technitium-99 in lung cancer: results of CALGB 140203 multicenter phase II trial. J Thorac Oncol. 2009 Feb;4(2):198-202. doi: 10.1097/JTO.0b013e318194a2c3.
PubMed 19179896
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Sentinel Node Mapping In Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00089310
- Acronym / sponsor ID
- CALGB-140203
- Conditions
- Lung Cancer
- Keywords
- stage I non-small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2004
- Primary completion
- Feb 2007 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 5 Aug 2004 (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 such as sentinel lymph node mapping may improve the ability to detect cancer that has spread to the lymph nodes.
PURPOSE: This clinical trial is studying how well sentinel lymph node mapping works in detecting cancer that has spread to the lymph nodes in patients who are undergoing surgery for stage I non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the feasibility and accuracy of intraoperative sentinel lymph node mapping using technetium Tc 99 sulfur colloid in patients with stage I non-small cell lung cancer.
- Determine the percentage of patients in which at least 1 positive sentinel lymph node is identified using this procedure.
- Determine the percentage of patients undergoing this procedure who are found to have positive sentinel lymph nodes with no metastases in other intrathoracic lymph nodes.
Secondary
- Determine the percentage of patients undergoing this procedure whose disease stage is upgraded due to detection of micrometastases in sentinel lymph nodes.
- Correlate the presence of micrometastases in sentinel lymph nodes with survival in patients undergoing this procedure.
- Determine the percentage of patients undergoing this procedure with "skip metastases" pattern (NZ) sentinel lymph nodes.
OUTLINE: This is a multicenter study.
Patients receive an intraoperative intratumoral injection of technetium Tc 99 sulfur colloid. At least 10 minutes later, patients undergo sentinel lymph node mapping using a gamma probe. Patients then undergo sentinel lymph node dissection and tumor resection. Pathology assays are performed using sentinel lymph node tissue, including hematoxylin and eosin staining, serial sections, and immunohistochemistry using the AE1/AE3/PCK2b cytokeratin antibody.
Patients are followed every 6 months for 2 years and then annually thereafter.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sentinal node mapping | Experimental | Radiation: technetium-99 |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| technetium-990.25 mCi in 4 equal doses | Radiation | Sentinal node mapping |
Primary outcome
Sentinel node identification
Time frame: at time of procedure
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 30 Jun 2016.
- Results publication: PubMed 19179896Liptay MJ, D'amico TA, Nwogu C, Demmy TL, Wang XF, Gu L, Litle VR, Swanson SJ, Kohman LJ; Thoracic Surgery Subcommittee of the Cancer and Leukemia Group B. Intraoperative sentinel node mapping with technitium-99 in lung cancer: results of CALGB 140203 multicenter phase II trial. J Thorac Oncol. 2009 Feb;4(2):198-202. doi: 10.1097/JTO.0b013e318194a2c3.
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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.
Thomas D'Amico, MD study chair
Duke University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing technetium-99 in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 12 sites 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 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Sentinel node identification (time frame: at time of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00089310, which also lists 1 linked publication.
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 30 Jun 2016.