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Radiation
SRS for Thoracoabdominal Wall Pain
Phase 1
Recruiting
Led By Josh Yamada, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is researching if a radiation treatment called SRS is a safe, feasible and effective way to treat chronic TAWP. They'll test different doses to find the safest and most effective dose.
Who is the study for?
This trial is for adults over 18 with chronic pain in the chest or stomach wall, lasting at least 3 months and not relieved by standard pain medication. They must have a certain level of physical functioning (KPS ≥ 60%) and life expectancy over 6 months. Exclusions include severe spinal deformities, excessive pleural effusion, inability to undergo specific diagnostic procedures, abnormal blood counts or coagulation profiles, severe respiratory disease, active autoimmune diseases, pneumothorax, recent chemotherapy or allergies to local anesthetics.Check my eligibility
What is being tested?
The study tests stereotactic radiosurgery (SRS) as a treatment for chronic thoracoabdominal wall pain (TAWP). Different doses of SRS will be used to determine the highest dose that's safe with few mild side effects. The effectiveness and practicality of SRS for this type of pain are also being evaluated.See study design
What are the potential side effects?
Potential side effects from SRS may include skin reactions at the treatment site, fatigue due to radiation exposure, possible inflammation around treated areas leading to discomfort or additional pain temporarily after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
can be escalated from 70 Gy to 90 Gy without excessive DLTs
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single-fraction stereotactic radiosurgery (SRS)Experimental Treatment1 Intervention
Patients will be treated with single-fraction radiation therapy at three dose levels:
70 Gy, 80 Gy, and 90 Gy using image-guided SRS techniques.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,880 Total Patients Enrolled
Varian Medical SystemsIndustry Sponsor
59 Previous Clinical Trials
3,761 Total Patients Enrolled
Josh Yamada, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
23 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a large amount of fluid in my chest.My treatment plan cannot safely follow the specific dose guidelines.I cannot have a nerve block procedure for diagnosis.I have had chest or belly wall pain for 3 months, confirmed by a specific nerve block test.I have an infection where I received an anesthetic injection.I am receiving chemotherapy around the same time as my targeted radiation therapy.I need oxygen support due to severe lung problems.My severe pain is not relieved by standard pain medication.I am ineligible if the radiation dose exceeds safe levels for my tissues.I have severe spine curvature.I can care for myself but may need occasional help.I am 18 years old or older.My previous radiation therapy doses to critical areas have been reviewed.My blood tests show low platelets, hemoglobin, or white cells, or my clotting is not normal.
Research Study Groups:
This trial has the following groups:- Group 1: Single-fraction stereotactic radiosurgery (SRS)
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 participants is this research endeavor involving?
"Affirmative. The clinicaltrials.gov page confirms that this trial is presently recruiting patients, having been posted on August 2nd of 2023 and last refreshed on the same date. 18 participants need to be recruited from seven distinct sites."
Answered by AI
Is Single-fraction stereotactic radiosurgery (SRS) legally permissible by the FDA?
"Since this is a Phase 1 trial with relatively little data backing its efficacy and safety, Single-fraction stereotactic radiosurgery (SRS) was assigned a score of 1."
Answered by AI
Are there any current opportunities for patients to participate in this research endeavor?
"Affirmative. Clinicaltrials.gov indicates that this clinical trial, which was initiated on August 2nd 2023, is still actively recruiting participants. Currently 18 patients need to be enrolled from 7 different medical centres."
Answered by AI
How many distinct venues are offering this clinical investigation?
"The research project is currently recruiting participants from 7 distinct centres which include Middletown, Montvale and Commack. It would be wise to join the trial at a location closest to you in order minimize total travelling time involved."
Answered by AI
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