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SBRT + Surgery for Lung Cancer (PSPM Trial)
N/A
Waitlist Available
Led By John Agzarian, MD, MPH
Research Sponsored by McMaster University
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 post operative 3 years
Awards & highlights
PSPM Trial Summary
This trial is testing whether a particular type of radiation therapy can help to shrink tumors and improve outcomes for people with lung cancer.
Who is the study for?
This trial is for adults over 18 with resectable lung metastases, treated primary cancer without local recurrence, and no more than one organ affected (except certain colorectal cancers). Participants must have tumors smaller than 5cm, no nodal disease on scans, and sufficient lung function to undergo surgery.Check my eligibility
What is being tested?
The study tests the effectiveness of SBRT in reducing tumor viability at a pathologic level. It also examines the outcomes of combining SBRT with surgical removal on low volume pulmonary metastases to improve treatment strategies for both primary and secondary lung cancers.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with radiation therapy such as skin irritation, fatigue, shortness of breath; and those related to surgery like pain, infection risk at the incision site, bleeding complications or issues from anesthesia.
PSPM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post operative 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post operative 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rates of complete pathologic response (pCR)
Secondary outcome measures
Disease-free survival (DFS)
Identify mRNA tumor markers by Circulating Tumor Cell/CTC test
Overall survival (OS)
+4 morePSPM Trial Design
1Treatment groups
Experimental Treatment
Group I: SBRT followed by pulmonary metastasectomyExperimental Treatment1 Intervention
SBRT+Surgery
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
880 Previous Clinical Trials
2,597,789 Total Patients Enrolled
John Agzarian, MD, MPHPrincipal InvestigatorMcMaster University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have more than 5 tumors in one lung.You have other health problems that cannot be treated with surgery.You have a cancer that is not under control.You have blood cancer like leukemia or lymphoma.You have received radiation treatment to the chest area in the past.You do not have any signs of lymph node disease on your CT scan before starting treatment.You can breathe well enough to have lung surgery (predicted FEV1≥40%).You are over 18 years old, have lung metastases that can be surgically removed, and there are no better treatment options available for your cancer.You have cancer that has spread to only one lung, except if you have colorectal cancer that has also spread to the liver at the same time.Your tumor is smaller than 5 centimeters.You were diagnosed with lung cancer within the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: SBRT followed by pulmonary metastasectomy
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.
Are recruitment efforts still underway for this research project?
"According to clinicaltrials.gov, this research is still looking for participants; the trial was initially posted on July 14th 2020 and has been amended most recently on February 23rd 2021."
Answered by AI
How many participants are receiving treatment within this trial?
"Affirmative. Clinicaltrials.gov confirms that this clinical study, which was launched on July 14th 2020, is still recruiting participants. Approximately 39 individuals need to be enrolled from a single site."
Answered by AI
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