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Radiation

Stereotactic Body Radiation Therapy for Early Stage Non-Small Cell Lung Cancer (POIMS Trial)

N/A
Recruiting
Led By Shalina Gupta-Burt, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage I-II NSCLC
Candidate for oncologic surgery (lobectomy or sub lobar resection) for the lung cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 18 months
Awards & highlights

POIMS Trial Summary

This trial will study the effects of radiation on the immune system in patients with early stage lung cancer who are surgical candidates. Tumor, normal tissue and blood specimens will be analyzed for changes in the immune system.

Who is the study for?
This trial is for people with early stage Non-Small Cell Lung Cancer (NSCLC) who can have surgery to remove it. They should have a tumor that's at least 2 cm away from the central airways and 1 cm from the outer lung layer, as judged safe by a surgeon. Participants need good lung function and enough biopsy tissue for analysis before starting treatment. Those with past chest surgery or radiation, prior immunotherapy, autoimmune diseases, or current use of drugs that weaken the immune system cannot join.Check my eligibility
What is being tested?
The POIMS Trial is testing if a specific type of targeted radiation therapy called non-ablative SBRT (800 cGy in three sessions) can modify the body's immune response against NSCLC when given before surgery. Researchers will study changes in immune cells within both blood and tumor tissues to understand how this approach might improve cancer treatments.See study design
What are the potential side effects?
While not explicitly listed in your information provided, side effects of non-ablative SBRT may include skin reactions at the treatment site, fatigue, shortness of breath, inflammation around normal lung tissue leading to coughing or pneumonia-like symptoms.

POIMS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer is in an early stage (Stage I or II).
Select...
I am eligible for lung cancer surgery.
Select...
My lung lesion is located in a place that can be surgically removed.

POIMS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in tumor T cell repertoire following pre and post SBRT
Secondary outcome measures
Impact of SBRT on post-surgical wound healing complication rate assessed by CTCAE v5
Loco-regional control disease
Metastasis-free survival
+2 more

POIMS Trial Design

1Treatment groups
Experimental Treatment
Group I: Non-ablative SBRTExperimental Treatment1 Intervention
Non-ablative SBRT (800 cGy X 3 fractions) given 5-7 days preoperatively in selected patients with stage I-II NSCLC

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
463 Previous Clinical Trials
169,260 Total Patients Enrolled
Shalina Gupta-Burt, MDPrincipal InvestigatorUniversity of Kansas Medical Center

Media Library

SBRT (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05094544 — N/A
Non-Small Cell Lung Cancer Research Study Groups: Non-ablative SBRT
Non-Small Cell Lung Cancer Clinical Trial 2023: SBRT Highlights & Side Effects. Trial Name: NCT05094544 — N/A
SBRT (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05094544 — N/A

Frequently Asked Questions

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

What is the participant capacity for this research project?

"Affirmative. According to clinicaltrials.gov, an up-to-date record of this medical trial is being kept and the recruitment process has commenced since October 1st 2021. The research requires 10 individuals from a single study site to be enrolled in total."

Answered by AI

Are there vacancies for participants in this investigation?

"Affirmative. Clinicaltrials.gov denotes that this medical research is actively searching for participants, having been first posted on October 1st 2021 and recently updated on March 21st 2022. At present, 10 individuals need to be enrolled from one specific site."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
~3 spots leftby Apr 2025