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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| UWCC-6228 | |||
| UWCC-UW-6228 | |||
| UW-04033 | |||
| LILY-UW-04033 | |||
| CDR0000441239 | Registry Identifier | PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET), (done before, during, and after chemotherapy) may help doctors predict a patient's response to treatment and help plan the best treatment. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well PET works in predicting response in patients who are undergoing treatment with pemetrexed disodium and cisplatin with or without surgery for stage I, stage II, or stage III non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant therapy, PET scan and surgery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug |
| ||
| pemetrexed disodium |
| Measure | Description | Time Frame |
|---|---|---|
| Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy | Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy | Between days 18 and 22 prior to second chemotherapy infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Neoadjuvant Chemotherapy | The number of patients that experienced a grade 3 or higher adverse event. | Up to 4 weeks after last dose of chemotherapy |
| Efficacy of Neoadjuvant Chemotherapy as Measured by Radiologic Response Rate |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
Stage IB, II, IIIA, or IIIB (T4, N0-1) disease
If N1 or N2 nodes are found by FDG-PET or CT scan, metastases must be ruled out by brain MRI
Measurable and resectable disease
Eligible for curative surgery
No malignant pleural effusion
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Adequate pulmonary reserve to undergo surgery
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
Able to take corticosteroids
Able to take folic acid or vitamin B_12 supplements
No other malignancy within the past 5 years except nonmelanoma skin cancer or noninvasive cervical cancer
No concurrent serious or uncontrolled disorder that would preclude study participation
No type I diabetes mellitus
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Renato Martins, MD, MPH | Seattle Cancer Care Alliance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Cancer Care Alliance | Seattle | Washington | 98109-1023 | United States | ||
| University of Washington School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30642285 | Derived | Romine PE, Martins RG, Eaton KD, Wood DE, Behnia F, Goulart BHL, Mulligan MS, Wallace SG, Kell E, Bauman JE, Patel SA, Vesselle HJ. Long term follow-up of neoadjuvant chemotherapy for non-small cell lung cancer (NSCLC) investigating early positron emission tomography (PET) scan as a predictor of outcome. BMC Cancer. 2019 Jan 14;19(1):70. doi: 10.1186/s12885-019-5284-2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neoadjuvant Therapy, PET Scan and Surgery | cisplatin pemetrexed disodium adjuvant therapy therapeutic conventional surgery fludeoxyglucose F 18 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| adjuvant therapy | Procedure |
|
| therapeutic conventional surgery | Procedure |
|
| fludeoxyglucose F 18 | Radiation |
|
The number of patients that had either a CR, PR or SD after the completion of chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
| Up to 4 weeks after last dose of chemotherapy |
| Seattle |
| Washington |
| 98195 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neoadjuvant Therapy, PET Scan and Surgery | cisplatin pemetrexed disodium adjuvant therapy therapeutic conventional surgery fludeoxyglucose F 18 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy | Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy | Only 19 patients had PET scans at both baseline and day 18-22 available for review. | Posted | Count of Participants | Participants | Between days 18 and 22 prior to second chemotherapy infusion |
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|
| ||||||||||||||||||||||||||
| Secondary | Safety of Neoadjuvant Chemotherapy | The number of patients that experienced a grade 3 or higher adverse event. | Posted | Count of Participants | Participants | Up to 4 weeks after last dose of chemotherapy |
|
| ||||||||||||||||||||||||||||
| Secondary | Efficacy of Neoadjuvant Chemotherapy as Measured by Radiologic Response Rate | The number of patients that had either a CR, PR or SD after the completion of chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. | One patient was excluded from the efficacy analysis because they were subsequently found to be ineligible. Three patients were unevaluable because they did not have have a CT scan after the completion of chemotherapy. | Posted | Count of Participants | Participants | Up to 4 weeks after last dose of chemotherapy |
|
|
Adverse events were collected from the time of first dose of chemotherapy through 4 weeks following the final dose of chemotherapy.
Only grade 3 and higher adverse events were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neoadjuvant Therapy, PET Scan and Surgery | cisplatin pemetrexed disodium adjuvant therapy therapeutic conventional surgery fludeoxyglucose F 18 | 1 | 25 | 10 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Drug Reaction | Immune system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pain | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| pneumonia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Renato G. Martins | University of Washington | 206-288-6680 | rgmart@uw.edu |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000068437 | Pemetrexed |
| D017024 | Chemotherapy, Adjuvant |
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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