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Proton Beam Radiation Therapy for Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Led By William Stokes

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Patients must have undergone complete surgical resection after pre-operative systemic therapy. Complete resections are defined as BOTH lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy AND lymph node dissection with at least three mediastinal (N2) stations sampled

Pathology report from surgical resection indicating complete resection of primary tumor (R0 resection) AND tumor involvement of at least one mediastinal lymph node (pN2) AND no tumor involvement of highest dissected mediastinal lymph node. Patients who have initially positive margins that are secondarily cleared on additional margins will be eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of surgery to the date of death with censoring at date of last follow up if alive, assessed up to 24 months after first dose of radiation

Awards & highlights

Study Summary

This trial tests proton beam radiation therapy to reduce cancer recurrence risk in those with non-small cell lung cancer who have had surgery. It may work better than conventional radiation.

Who is the study for?

This trial is for adults over 18 with non-small cell lung cancer who've had surgery to remove the tumor and affected lymph nodes. They should be in decent health, have a life expectancy of more than 12 weeks, and not be pregnant or planning to become so during the trial. Participants must agree to use contraception and have finished any previous cancer treatments at least two weeks before starting.Check my eligibility

What is being tested?

The study is testing proton beam radiation therapy as a post-surgery treatment for lung cancer patients. Proton therapy targets cancer cells while sparing healthy tissue, potentially reducing recurrence risk compared to conventional radiation.See study design

What are the potential side effects?

Proton beam radiation may cause side effects like skin redness or irritation where treated, fatigue, difficulty swallowing if treating near the esophagus, and potential damage to nearby organs depending on treatment location.

Eligibility Criteria

Inclusion Criteria

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

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I had surgery to remove lung cancer completely, including part of the lung and lymph nodes.

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My surgery removed all of my primary tumor and affected a key lymph node but not the highest one.

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of surgery to the date of local, regional, or distant recurrence or death, whichever earlier, with censoring at the date of the last follow up, assessed up to 24 months after first dose of radiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of surgery to the date of local, regional, or distant recurrence or death, whichever earlier, with censoring at the date of the last follow up, assessed up to 24 months after first dose of radiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of surgery to the date of local, regional, or distant recurrence or death, whichever earlier, with censoring at the date of the last follow up, assessed up to 24 months after first dose of radiation for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of adverse events (AEs)

Secondary outcome measures

Disease-free survival

Overall survival

Radiation dose to immune compartment

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (proton beam radiation therapy)Experimental Treatment3 Interventions

Patients undergo radiation treatment planning and then undergo proton beam radiation therapy on study. Patients also undergo collection of blood samples.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1730

Proton Beam Radiation Therapy

2013

Completed Phase 2

~110

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,553 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,133 Total Patients Enrolled

William StokesPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute

Frequently Asked Questions

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

What risks should a patient consider before undergoing proton beam radiation therapy?

"Considering the evidence from Phase 2 trials, which only provides data on safety rather than efficacy, our team at Power estimates Treatment (proton beam radiation therapy) to have a score of 2."

Answered by AI

Are there still openings to participate in this examination?

"Data hosted on clinicaltrials.gov reveals this medical study is not actively recruiting participants. It was first announced on October 31st, 2023 and last modified on August 22nd, 2023; yet, 1364 other studies are still seeking enrolment at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Proton Beam Radiation Therapy After Treatment for Resected N2 Non-Small Cell Lung Cancer

Bill Stokes 2024. "Proton Beam Radiation Therapy After Treatment for Resected N2 Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06008730.