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This study was terminated after interim analyses showed no benefits.
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This is a pilot study of biomarker evaluation and safety of pre-incisional ketorolac for patients undergoing surgical resection for non-small cell lung cancer and renal cell carcinoma. There is significant promise in the use of preoperative ketorolac to decrease the inflammatory response after surgical resection of tumors, thereby potentially reducing the risk of distant metastatic tumor spread and improving survival. This research will advance scientific knowledge by studying the safety of a preoperative dose of ketorolac prior to major surgical resection, which needs to be assessed prior to proceeding with a larger phase II study designed to evaluate traditional efficacy endpoints such as recurrence and overall survival.
Surgical resection is a cornerstone of standard-of-care treatment for early-stage non-small cell lung carcinoma (NSCLC) and renal cell carcinoma (RCC). Yet despite optimal treatment, many of these patients will develop cancer recurrence within the first few years. For example, the 5-year survival rate for patients with stage I/II NSCLC is only around 55%. As a result, more effective treatments that decrease cancer recurrence and increase survival are still needed.
Surgery induces inflammation, immunosuppression and angiogenesis. Although these processes are important for wound healing in response to tissue injury caused by surgery, they also support the survival, growth and dissemination of any remaining cancer cells and can lead to systemic recurrence soon after surgery. Surgical trauma increases the production of prostaglandins and thromboxanes, which have tumor-promoting and immunosuppressive activities, and reduces the activity of natural killer cells, which impairs the ability of the immune system to keep cancer cells in check. However, if given just before tissue injury, non-steroidal anti-inflammatory drugs (NSAIDs) may be able to block the production of prostaglandins/thromboxanes and boost the activity of natural killer cells, and thereby decrease the risk of cancer recurrence. NSAIDs such as ketorolac are already routinely given to cancer patients postoperatively for pain management and are sometimes given intraoperatively (immediately before or during surgery) to prevent postoperative pain. A retrospective clinical analysis found that intraoperative intravenous ketorolac or diclofenac (another NSAID), when added to standard of care for patients with stage I/II NSCLC, was associated with decreased risks of distant recurrence and mortality.
In this study, patients with NSCLC or RCC will be screened and recruited during the preoperative period by the responsible medical and surgical team. Participants will be randomized on the day of surgery to either the preoperative ketorolac group or a concurrent control group who will not receive preincisional ketorolac. Participants will be followed for 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative Ketorolac For Participants with Non-small Cell Lung Carcinoma (NSCLC) | Experimental | Participants randomized to receive ketorolac prior to surgery for stage I/II non-small cell lung carcinoma (NSCLC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. |
|
| Control Group For Participants with Non-small Cell Lung Carcinoma (NSCLC) | No Intervention | Participants randomized to the control group receiving the standard of care during surgery for stage I/II non-small cell lung carcinoma (NSCLC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints. | |
| Preoperative Ketorolac For Participants with renal cell carcinoma (RCC) | Experimental | Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. |
|
| Control Group For Participants with renal cell carcinoma (RCC) | No Intervention | Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative Ketorolac | Drug | 30 mg ketorolac will be administered intravenously 30 minutes prior to incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Receiving a Blood Transfusion | Hemorrhagic side effects among participants receiving ketorolac preoperatively will be assessed as the need for blood transfusions before being discharged from the hospital after surgery. The need for a blood transfusion is defined as needing two or more units of blood, which are not related to vascular injury due to technical considerations or complications, as determined by the operating surgeon. | Prior to Hospital Discharge (up to 13 days post surgery) |
| Number of Participants Experiencing Clinically Significant Hematoma Development | Post-surgical significant hematoma development is assessed as the number of participants experiencing a hematoma prior to hospital discharge. | Prior to Hospital Discharge (up to 13 days post surgery) |
| Number of Participants Returning to the Operating Room for Bleeding | Post-operative bleeding is assessed at the number of participants needing to return to the operating room for bleeding, as determined by the treating surgeon. | Prior to Hospital Discharge (up to 13 days post surgery) |
| Number of Participants Experiencing Postoperative Renal Failure | Postoperative renal failure is assessed as the number of participants experiencing renal failure prior to hospital discharge. | Prior to Hospital Discharge (up to 13 days post surgery) |
| Number of Participants Experiencing Postoperative Morbidity | Postoperative morbidity is assessed as the count of participants experiencing at least one adverse event or serious adverse event from surgery to hospital discharge. | Prior to Hospital Discharge (up to 13 days post surgery) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Transcriptome Analysis | Transcriptome analysis will be performed to evaluate the effects of ketorolac on immune response pathways. | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 |
| Flow Cytometry |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Viraj Master, MD, PhD | Emory University | Principal Investigator |
| Onkar Khullar, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States | ||
| Emory Clinic |
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Participants were recruited from the Emory Clinic, Emory University Hospital Midtown, Emory University Hospital, and the Winship Cancer Institute in Atlanta, Georgia, USA. Participant enrollment began August 24, 2020 the final study assessment occurred February 1, 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Preoperative Ketorolac For Participants With Non-small Cell Lung Carcinoma (NSCLC) | Participants randomized to receive ketorolac prior to surgery for stage I/II non-small cell lung carcinoma (NSCLC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2024 |
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|
Flow Cytometry will be performed to evaluate the effects of ketorolac on immune response pathways.
| Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 |
| T-Cell Receptor (TCR) Sequencing | T-Cell receptor (TCR) sequencing will be performed to evaluate the effects of ketorolac on immune response pathways. | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 |
| Single Cell RNA Sequencing | Single cell RNA sequencing will be performed to evaluate the effects of ketorolac on immune response pathways. | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 |
| Interleukin-1 Alpha (IL-1alpha) Levels | IL-1alpha levels will be compared between study arms. | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 |
| Interleukin-1beta (IL-1β) Levels | IL-1beta levels will be compared between study arms. | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 |
| Interleukin-2 (IL-2) Levels | IL-2 levels will be compared between study arms. | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 |
| Interleukin-6 (IL-6) Levels | IL-6 levels will be compared between study arms. | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 |
| Interleukin-8 (IL-8) Levels | IL-8 levels will be compared between study arms. | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 |
| Interleukin-10 (IL-10) Levels | IL-10 levels will be compared between study arms. | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 |
| Interleukin-12p70 (IL-12p70) Levels | IL-12p70 levels will be compared between study arms. | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 |
| Tumor Necrosis Factor-alpha (TNF-alpha) Levels | TNF-alpha levels will be compared between study arms. | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 |
| Interferon (INF)-Gamma Levels | INF-gamma levels will be compared between study arms. | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 |
| Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Levels | GM-CSF levels will be compared between study arms. | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 |
| Monocyte Chemotactic and Activating Factor (MCAF) Levels | MCAF levels will be compared between study arms. | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| FG001 | Control Group For Participants With Non-small Cell Lung Carcinoma (NSCLC) | Participants randomized to the control group receiving the standard of care during surgery for stage I/II non-small cell lung carcinoma (NSCLC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints. |
| FG002 | Preoperative Ketorolac For Participants With Renal Cell Carcinoma (RCC) | Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision. |
| FG003 | Control Group For Participants With Renal Cell Carcinoma (RCC) | Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints. |
|
| Participants Who Started the Study Activities of Ketorolac Administration (if Assigned) and Surgery |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Baseline Analysis Population includes participants who started the study activities of administration of ketorolac (for participants in a ketorolac study arm) and had their standard of care surgery.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Preoperative Ketorolac For Participants With Non-small Cell Lung Carcinoma (NSCLC) | Participants randomized to receive ketorolac prior to surgery for stage I/II non-small cell lung carcinoma (NSCLC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision. |
| BG001 | Control Group For Participants With Non-small Cell Lung Carcinoma (NSCLC) | Participants randomized to the control group receiving the standard of care during surgery for stage I/II non-small cell lung carcinoma (NSCLC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints. |
| BG002 | Preoperative Ketorolac For Participants With Renal Cell Carcinoma (RCC) | Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision. |
| BG003 | Control Group For Participants With Renal Cell Carcinoma (RCC) | Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Number of Participants Receiving a Blood Transfusion | Hemorrhagic side effects among participants receiving ketorolac preoperatively will be assessed as the need for blood transfusions before being discharged from the hospital after surgery. The need for a blood transfusion is defined as needing two or more units of blood, which are not related to vascular injury due to technical considerations or complications, as determined by the operating surgeon. | Posted | Count of Participants | Participants | Prior to Hospital Discharge (up to 13 days post surgery) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Experiencing Clinically Significant Hematoma Development | Post-surgical significant hematoma development is assessed as the number of participants experiencing a hematoma prior to hospital discharge. | Posted | Count of Participants | Participants | Prior to Hospital Discharge (up to 13 days post surgery) |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Returning to the Operating Room for Bleeding | Post-operative bleeding is assessed at the number of participants needing to return to the operating room for bleeding, as determined by the treating surgeon. | Posted | Count of Participants | Participants | Prior to Hospital Discharge (up to 13 days post surgery) |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Experiencing Postoperative Renal Failure | Postoperative renal failure is assessed as the number of participants experiencing renal failure prior to hospital discharge. | Posted | Count of Participants | Participants | Prior to Hospital Discharge (up to 13 days post surgery) |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Experiencing Postoperative Morbidity | Postoperative morbidity is assessed as the count of participants experiencing at least one adverse event or serious adverse event from surgery to hospital discharge. | Posted | Count of Participants | Participants | Prior to Hospital Discharge (up to 13 days post surgery) |
| ||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Transcriptome Analysis | Transcriptome analysis will be performed to evaluate the effects of ketorolac on immune response pathways. | Not Posted | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Flow Cytometry | Flow Cytometry will be performed to evaluate the effects of ketorolac on immune response pathways. | Not Posted | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | T-Cell Receptor (TCR) Sequencing | T-Cell receptor (TCR) sequencing will be performed to evaluate the effects of ketorolac on immune response pathways. | Not Posted | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Single Cell RNA Sequencing | Single cell RNA sequencing will be performed to evaluate the effects of ketorolac on immune response pathways. | Not Posted | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Interleukin-1 Alpha (IL-1alpha) Levels | IL-1alpha levels will be compared between study arms. | Not Posted | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Interleukin-1beta (IL-1β) Levels | IL-1beta levels will be compared between study arms. | Not Posted | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Interleukin-2 (IL-2) Levels | IL-2 levels will be compared between study arms. | Not Posted | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Interleukin-6 (IL-6) Levels | IL-6 levels will be compared between study arms. | Not Posted | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Interleukin-8 (IL-8) Levels | IL-8 levels will be compared between study arms. | Not Posted | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Interleukin-10 (IL-10) Levels | IL-10 levels will be compared between study arms. | Not Posted | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Interleukin-12p70 (IL-12p70) Levels | IL-12p70 levels will be compared between study arms. | Not Posted | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Tumor Necrosis Factor-alpha (TNF-alpha) Levels | TNF-alpha levels will be compared between study arms. | Not Posted | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Interferon (INF)-Gamma Levels | INF-gamma levels will be compared between study arms. | Not Posted | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Levels | GM-CSF levels will be compared between study arms. | Not Posted | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Monocyte Chemotactic and Activating Factor (MCAF) Levels | MCAF levels will be compared between study arms. | Not Posted | Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28 | Participants |
Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
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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 | Preoperative Ketorolac For Participants With Non-small Cell Lung Carcinoma (NSCLC) | Participants randomized to receive ketorolac prior to surgery for stage I/II non-small cell lung carcinoma (NSCLC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision. | 0 | 14 | 2 | 14 | 6 | 14 |
| EG001 | Control Group For Participants With Non-small Cell Lung Carcinoma (NSCLC) | Participants randomized to the control group receiving the standard of care during surgery for stage I/II non-small cell lung carcinoma (NSCLC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | Preoperative Ketorolac For Participants With Renal Cell Carcinoma (RCC) | Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision. | 0 | 28 | 1 | 28 | 16 | 28 |
| EG003 | Control Group For Participants With Renal Cell Carcinoma (RCC) | Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints. | 0 | 10 | 2 | 10 | 6 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hypotension | General disorders | Non-systematic Assessment |
| ||
| Elevated cardiac troponin | Cardiac disorders | Non-systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Subcutaneous emphysema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Thrombophlebitis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Hypertension | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Hypotension | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea/vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Esophagitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Belching/bloating | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pneumoperitoneum | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dizziness | General disorders | Non-systematic Assessment |
| ||
| Allergic reaction to oxycodone | General disorders | Non-systematic Assessment |
| ||
| Edema | General disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| External ear pain | General disorders | Non-systematic Assessment |
| ||
| Eye irritation | General disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Endocrine disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Endocrine disorders | Non-systematic Assessment |
| ||
| Itching | General disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Tremor | General disorders | Non-systematic Assessment |
| ||
| Wound infection | Infections and infestations | Non-systematic Assessment |
| ||
| Numbness (right hand) | General disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| High chest tube output | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Persistent air leak | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Rib cage pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Low urine output | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Incontinence | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Viraj Master, MD, PhD | Emory University | 404-778-4898 | vmaster@emory.edu |
| Jan 28, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020911 | Ketorolac Tromethamine |
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision. |
| OG003 | Control Group For Participants With Renal Cell Carcinoma (RCC) | Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints. |
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Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision. |
| OG003 | Control Group For Participants With Renal Cell Carcinoma (RCC) | Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints. |
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Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision. |
| OG003 | Control Group For Participants With Renal Cell Carcinoma (RCC) | Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints. |
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Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision. |
| OG003 | Control Group For Participants With Renal Cell Carcinoma (RCC) | Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints. |
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