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Radiation

One Fraction SBRT for Lung Cancer (ONE STOP Trial)

N/A

Recruiting

Led By Pamela Samson, M.D., MPHS

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical AJCC stage IB defined as T2aN0M0, T2a tumor between 3 and 4 cm

Tumors and anatomy amenable to one-fraction lung SBRT confirmed by meeting of one-fraction lung SBRT target and constraint metrics on a diagnostic-scan based preplan

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1

Awards & highlights

ONE STOP Trial Summary

This trial aims to investigate a new treatment approach for patients with early-stage lung cancer or lung metastases. The current standard treatment, called stereotactic body radiotherapy (SBRT), can be difficult

Who is the study for?

This trial is for patients with early-stage non-small cell lung cancer or those with a few lung metastases who can't easily get to a treatment center. They must be able to give consent over the phone/online and have diagnostic scans suitable for planning their radiotherapy.Check my eligibility

What is being tested?

The study tests a new way of delivering stereotactic body radiotherapy (SBRT) using HyperSight/Ethos technology, which could shorten the treatment process from weeks to hours by eliminating certain steps like simulation.See study design

What are the potential side effects?

Potential side effects may include skin reactions, fatigue, shortness of breath, chest pain, and coughing similar to other forms of radiation therapy but are expected to be minimal due to precise targeting.

ONE STOP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is stage IB, with a tumor size between 3 and 4 cm.

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My tumor and body structure are suitable for a specific one-time radiation therapy.

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I am 18 years old or older.

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My cancer is stage IIA, with a tumor size between 4 and 5 cm.

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My lung tumor is a result of cancer that started elsewhere in my body.

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My cancer spots are small and located on the outer parts.

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My tumor is 5 cm in size or smaller.

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My lung cancer is in an early stage (I-IIA).

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My cancer is in an early stage, not larger than 3 cm and hasn't spread.

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My cancer lesion moves less than 1 cm, confirmed by a special CT scan.

ONE STOP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of the ONE STOP workflow

ONE STOP Trial Design

1Treatment groups

Experimental Treatment

Group I: One Fraction SBRTExperimental Treatment3 Interventions

Consenting and eligible patients will receive a prescription dose of 25-34 Gy in one fraction with adaptation based on daily anatomic changes as per clinical standard of care.

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,685 Total Patients Enrolled

Varian Medical SystemsIndustry Sponsor

59 Previous Clinical Trials

3,769 Total Patients Enrolled

Pamela Samson, M.D., MPHSPrincipal InvestigatorWashington University School of Medicine

3 Previous Clinical Trials

82 Total Patients Enrolled

Frequently Asked Questions

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

Is the enrollment for this clinical trial currently open?

"As per the information provided on clinicaltrials.gov, this trial is not currently seeking participants. However, there are 1579 other ongoing trials actively recruiting patients at present. This particular study was initially posted on February 28th, 2024 and its most recent update occurred on January 23rd, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

One Fraction Simulation-Free Treatment With CT-Guided Stereotactic Adaptive Radiotherapy for Patients With Oligometastatic and Primary Lung Tumors

2024. "One Fraction Simulation-Free Treatment With CT-Guided Stereotactic Adaptive Radiotherapy for Patients With Oligometastatic and Primary Lung Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06236516.