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TTFields for Lung Cancer
Phase 1
Recruiting
Led By Prasad Adusumilli, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The participant has clinical stage IA3 or IB biopsy-proven lung ADC and is eligible for anatomical resection.
The participant is ≥22 years of age on the day of signing informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial tests if a new treatment for lung cancer is safe and effective, and could help the body fight it.
Who is the study for?
This trial is for adults over 22 with a specific lung cancer called adenocarcinoma, who are eligible for surgery to remove it. They must have a tumor larger than 2 cm and no history of other cancers (with some exceptions) in the last five years. It's not for those with certain heart issues, pacemakers, very small or less solid tumors, or active treatment for another cancer.Check my eligibility
What is being tested?
The study tests the NovoTTF-200T System which uses Tumor-Treating Fields (TTFields) before surgery on lung adenocarcinoma patients. The goal is to see if this method is safe and doable, and how it might boost the body's own fight against cancer.See study design
What are the potential side effects?
While specific side effects aren't listed here, TTFields therapy generally can cause skin irritation under device electrodes, headaches, malaise and muscle twitching. Each person may experience these differently.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is at an early stage and I can have surgery to remove it.
Select...
I am 22 years old or older.
Select...
I have a lung nodule larger than 2 cm and am scheduled for a biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events, severity and frequency
Trial Design
1Treatment groups
Experimental Treatment
Group I: NovoTTF-200T System Tumor-Treating Fields (TTFields)Experimental Treatment1 Intervention
Following pathological confirmation on of lung ADC, patients will proceed with TTFields treatment. The NovoTTF-200T System is an investigational medical device delivering 150 kHz TTFields to the patient's chest. The device is applied continuously for an average duration of 18 hours per day for 3 weeks (+/- 1 week).
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,873 Total Patients Enrolled
NovoCure Ltd.Industry Sponsor
57 Previous Clinical Trials
4,707 Total Patients Enrolled
Prasad Adusumilli, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
537 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung cancer is at an early stage and I can have surgery to remove it.My lung nodules are less than half solid.I am currently being treated for another cancer.My lung scans show areas that are completely 'foggy' looking.I have no cancer history, except for certain skin, bladder, or cervical cancers, or I've been cancer-free for 5 years after treatment.I am 22 years old or older.I have a history of heart rhythm problems or use a pacemaker.You have small lung nodules less than 2 centimeters in size.I have at least one tumor that fits the trial's requirements.I have a lung nodule larger than 2 cm and am scheduled for a biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: NovoTTF-200T System Tumor-Treating Fields (TTFields)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many institutes are overseeing this research initiative?
"There are 7 clinical trial sites participating in this study, including Memorial Sloan Kettering Monmouth (Consent Only) located in Middletown and Memorial Sloan Kettering Bergen (Consent Only) found in Montvale. Additionally, there are other 5 research facilities recruiting patients for the project."
Answered by AI
Has the FDA ratified NovoTTF-200T System Tumor-Treating Fields (TTFields)?
"We gave NovoTTF-200T System Tumor-Treating Fields (TTFields) a score of 1 since this is only in the first phase of clinical trials and there are minimal data points to assess its efficacy and safety."
Answered by AI
Are there any vacant slots left in this research program?
"Clinicaltrials.gov confirms that this clinical trial, which was posted on March 1st of 2023 and last updated two days later, is no longer accepting enrolments from patients. However, there are currently 796 other trials actively enrolling participants at this time."
Answered by AI
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