Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer
Study Details
Study Description
Brief Summary
This study is designed to evaluate the accuracy of lung cancer biomarkers found in the blood in determining if a lung nodule is cancer or benign. Investigators also plan to use another biomarker found in the tumor tissue to identify participants after lung cancer surgery who have a high risk for recurrent cancer so that they can be offered additional drug treatment that will improve their chances of long-term cure. Finally, investigators plan to use one of the blood-based biomarkers to detect any late cancer recurrence
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High-Risk for Recurrence That Accept Adjuvant Chemotherapy Participants whose gene assay show that they are at a higher risk of recurrence will be offered to receive postoperative chemotherapy. If participants also have a special mutation on the tumor (EGFR), investigators will recommend that the participant also receive the oral anti-EGFR pill (TagrissoTM) daily for 3 years after completing the chemotherapy. The administration of standard postoperative chemotherapy is not considered part of the study. Only the results of the DetermaRx test and the potential referral to a medical oncologist are part of this study. |
Diagnostic Test: DetermaRX
A lung tissue biomarker to risk stratify patients immediately after curative lung cancer resections into groups with low risk versus intermediate-high risk for recurrence of cancer. Intermediate-high risk patients will be advised to undergo adjuvant chemotherapy with the expectation of decreasing their chance of recurrence. The effectiveness and toxicity of the adjuvant chemotherapy itself is considered not part of the study-just the decision to recommend adjuvant chemotherapy is the study intervention. Investigators will then evaluate the long-term survival results of low-risk patients (no adjuvant treatment) and intermediate-high risk patients receiving adjuvant treatment versus intermediate-high risk patients who decline adjuvant therapy.
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| Experimental: High-Risk for Recurrence That Decline Adjuvant Chemotherapy Participants whose gene assay show that they are at a higher risk of recurrence will be offered to receive postoperative chemotherapy. If participant declines, investigators will followup with participants periodically every 6-12 months over 5 years. |
Diagnostic Test: DetermaRX
A lung tissue biomarker to risk stratify patients immediately after curative lung cancer resections into groups with low risk versus intermediate-high risk for recurrence of cancer. Intermediate-high risk patients will be advised to undergo adjuvant chemotherapy with the expectation of decreasing their chance of recurrence. The effectiveness and toxicity of the adjuvant chemotherapy itself is considered not part of the study-just the decision to recommend adjuvant chemotherapy is the study intervention. Investigators will then evaluate the long-term survival results of low-risk patients (no adjuvant treatment) and intermediate-high risk patients receiving adjuvant treatment versus intermediate-high risk patients who decline adjuvant therapy.
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| Experimental: Low-Risk for Recurrence Participants whose gene assay show that they are at a lower risk of recurrence will not be offered additional treatment after resection. Investigators will followup with participants periodically every 6-12 months over 5 years. |
Diagnostic Test: DetermaRX
A lung tissue biomarker to risk stratify patients immediately after curative lung cancer resections into groups with low risk versus intermediate-high risk for recurrence of cancer. Intermediate-high risk patients will be advised to undergo adjuvant chemotherapy with the expectation of decreasing their chance of recurrence. The effectiveness and toxicity of the adjuvant chemotherapy itself is considered not part of the study-just the decision to recommend adjuvant chemotherapy is the study intervention. Investigators will then evaluate the long-term survival results of low-risk patients (no adjuvant treatment) and intermediate-high risk patients receiving adjuvant treatment versus intermediate-high risk patients who decline adjuvant therapy.
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Outcome Measures
Primary Outcome Measures
- Disease Free Survival [Up to 5 years]
Disease-free survival (DFS) is defined as the time from surgical resection and adjuvant chemotherapy to recurrence of tumor or death
- Overall Survival [Up to 5 Years]
Overall survival (OS) is defined as the time (days) from the date of surgical resection and adjuvant chemotherapy to the date of death, due to any reason.
Secondary Outcome Measures
- Tumor Malignancy [At 6 Months]
Fisher exact test will used to test association of both LCDT1™ and NodifyXL2® blood tests with malignancy.
- Cancer Recurrence [At 6 Months]
Fisher exact test will used to test association of LCDT-1™ blood test with cancer recurrence.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Potentially-resectable lung nodule 8-40 mm diameter suspected (no preop diagnosis) of being a clinically node-negative lung cancer [clinical stage IA-IB (cT1a-T2aN0), <4cm diameter].
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If surgical resection is recommended, patient will undergo surgery at Moffitt Cancer Center.
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If a definite tissue diagnosis is obtained and stereotactic body radiotherapy (SBRT) is the recommended treatment instead of surgery, the SBRT will be delivered at Moffitt Cancer Center.
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18 years old, male or female.
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ECOG performance status 0-1.
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Participants must have adequate organ and bone marrow function as defined below:
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- absolute neutrophil count ≥1,000/mcL
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- platelets ≥70,000/mcL
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- total bilirubin ≤ institutional upper limit of normal (ULN)
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- AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
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- creatinine 3.0 ≤ institutional ULN
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Agree to participate in the follow-up protocol.
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Any primary lung cancer cell type (except a suspected typical carcinoid tumor, carcinoma in situ or minimally-invasive carcinoma).
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Ability to understand and the willingness to sign a written, informed consent document.
Exclusion Criteria:
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Participants who have had chemotherapy or radiotherapy within 2 years of entering the study.
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Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1), with the exception of alopecia.
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Participants who are actively receiving any cancer treatment.
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History of allergic reactions attributed to adjuvant chemotherapy agents used in study.
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Participants with uncontrolled intercurrent illness.
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Prior lung cancer within 5 years.
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Current active other major cancer except non-melanoma skin cancer.
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Patients with pure ground glass opacities (nodules) or hilar masses.
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Suspected typical carcinoid cell type (well-differentiated neuroendocrine carcinoma).
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Metastatic nodule (suspected) in the lung from an extrapulmonary cancer.
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Pregnant or lactating female.
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Patient unable to provide informed consent.
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Prisoner or incarcerated individual.
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For surgical patients, a R1 or R2 resection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
Sponsors and Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
Investigators
- Principal Investigator: Lary A Robinson, MD, Moffitt Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MCC-21767