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Pre-Incisional Ketorolac for Lung Cancer

Phase < 1
Recruiting
Led By Viraj Master, MD, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Pathology-proven or suspected stage 1 or 2 NSCLC and Stage 3 tumor stage 3, node stage 0 (T3N0) RCC, that require surgical resection as the treatment of choice
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 1, day 3 (if admitted to hospital), day 7, day 28
Awards & highlights

Study Summary

This trialwill study if pre-surgery ketorolac can reduce the risk of distant tumor spread, potentially improving survival. 56 patients will get ketorolac, w/ 10 additional patients in a control group. Results will inform future studies on recurrence & survival.

Who is the study for?
This trial is for adults with early-stage non-small cell lung cancer or renal cell carcinoma who need surgery. They should be in good enough health to understand and agree to the study, not have had certain cancers recently, no severe kidney issues, allergies to NSAIDs, bleeding disorders, or be over 80 years old.Check my eligibility
What is being tested?
The study tests if giving a drug called Ketorolac before surgery can help reduce inflammation and lower the chance of cancer spreading after tumor removal. Out of 76 patients enrolled, most will receive Ketorolac pre-surgery while about 20 won't as a comparison group.See study design
What are the potential side effects?
Ketorolac may cause stomach ulcers, kidney problems in those already at risk, allergic reactions if sensitive to NSAIDs (like ibuprofen), and increased bleeding due to its blood-thinning effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My lung or kidney cancer is in an early stage and surgery is recommended.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 1, day 3 (if admitted to hospital), day 7, day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 1, day 3 (if admitted to hospital), day 7, day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Blood Transfusion Among Ketorolac Group
Incidence of Clinically Significant Hematoma Development Among Ketorolac Group
Incidence of Postoperative Morbidity Rate Among Ketorolac Group
+2 more
Secondary outcome measures
Change in Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Levels
Change in Interferon (INF)-gamma Levels
Change in Interleukin-1 alpha (IL-1alpha) Levels
+8 more
Other outcome measures
Change in Flow Cytometry
Change in Single Cell RNA Sequencing
Change in T-Cell Receptor (TCR) Sequencing
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Preoperative KetorolacExperimental Treatment1 Intervention
Participants randomized to receive ketorolac prior to surgery for stage I/II NSCLC and stage III RCC. Participants will receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia will be administered.
Group II: Control GroupActive Control1 Intervention
Participants randomized to the control group receiving the standard of care during surgery for stage I/II NSCLC and stage III RCC. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia will be administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.

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Who is running the clinical trial?

Emory UniversityLead Sponsor
1,634 Previous Clinical Trials
2,560,097 Total Patients Enrolled
Viraj Master, MD, PhDPrincipal Investigator - Emory University
Emory Saint Joseph's, Emory University Hospital, Emory University Hospital Midtown, Grady Memorial Hospital
University Of Chicago (Medical School)
University Ca Sf School Of Medicine (Residency)
1 Previous Clinical Trials
55 Total Patients Enrolled
Onkar Khullar, MDPrincipal InvestigatorEmory University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Preoperative Ketorolac been researched in any previous experiments?

"Currently, there are 38 live clinical trials studying the use of Preoperative Ketorolac with 8 in Phase 3. These experiments predominantly take place in California's largest city but span across 57 different locations globally."

Answered by AI

How many participants are currently being recruited for this clinical trial?

"Affirmative. Clinicaltrials.gov has verified that this clinical trial is currently recruiting participants, beginning with a post date of August 24th 2020 and last updated on October 10th 2022. 76 individuals need to be enrolled from 4 medical sites for the study."

Answered by AI

Which individuals are eligible for participation in this clinical investigation?

"The requirements to be considered for this clinical trial include having renal cell carcinoma and being aged between 18-80. The research is looking to recruit a total of 76 individuals."

Answered by AI

What therapeutic benefits does Preoperative Ketorolac provide?

"Ocular itching can be alleviated via the use of preoperative ketorolac, which has been proven to reduce pain, facilitate nerve block induction and regulate pupil size."

Answered by AI

Are volunteers able to enroll in this experiment at the present time?

"As detailed on clinicaltrials.gov, this experiment is actively recruiting volunteers. It was first announced to the public on August 24th 2020 and its information was most recently updated October 10th 2022."

Answered by AI

What are the aims of this experiment?

"This clinical trial, assessed over a Prior to Hospital Discharge window (which typically lasts up to 7 days after the surgical procedure), seeks to measure the Incidence of Postoperative Morbidity Rate Among Ketorolac Group. Additionally, secondary objectives encompass evaluating differences in Interleukin-1 alpha (IL-1alpha) Levels, Interleukin-2 (IL-2) Levels and Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Levels between study arms."

Answered by AI

Does the age criterion for this experiment include individuals beyond four decades of life?

"This trial is looking for individuals aged 18 and older, but not exceeding 80 years of age."

Answered by AI
~9 spots leftby Oct 2024