Hypofractionated Radiation Therapy for Lung Cancer

(PREVENT-LUNG Trial)

Recruiting at 1 trial location

Overseen By David Palma, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Chris Goodman

Disqualifiers: Prior thoracic radiotherapy, Interstitial lung disease, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

141 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of radiation treatments for lung cancer that has spread within the chest. One group receives standard radiation therapy, while the other receives a new, higher-dose treatment called hypofractionated radiation therapy, designed to reduce harm to the esophagus (the tube connecting the throat and stomach). The goal is to determine if the new method can deliver more effective doses, improve symptoms, and enhance overall survival. Participants should have lung cancer requiring radiation to relieve symptoms or prevent future issues.

As an unphased trial, this study allows patients to contribute to innovative research that could lead to improved treatment options.

What prior data suggests that this radiation therapy technique is safe for lung cancer patients?

Research has shown that hypofractionated radiation therapy, which involves delivering larger doses of radiation in fewer sessions, is generally well-tolerated. In studies, most patients experienced manageable side effects. For instance, one study found that only 6.3% of patients had significant unwanted effects. Another study demonstrated that this therapy controlled cancer effectively, with success rates of 96.7% after one year and 76.9% after three years.

Although this therapy may not improve survival compared to traditional methods, it offers a shorter treatment period. This can be more convenient for patients and may lead to quicker relief from symptoms. Overall, evidence suggests that this therapy is a safe option for many, focusing on effective treatment while minimizing side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Hypofractionated radiation therapy is unique because it delivers a higher dose of radiation in fewer sessions compared to traditional radiation therapy. While standard treatments might involve multiple weeks of daily sessions, this approach aims to complete treatment in just five sessions with 35 Gray, potentially reducing the overall treatment time and burden on patients. Researchers are excited about this method because it could lead to increased convenience and potentially improved patient outcomes by maintaining or even enhancing the effectiveness of the treatment while minimizing side effects.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research has shown that hypofractionated radiation therapy, which uses larger doses of radiation in fewer sessions, can effectively control tumors, particularly in lung cancer. In this trial, participants will receive either standard radiotherapy or experimental hypofractionated radiotherapy. One study found that this high-dose method successfully controlled tumors in non-small cell lung cancer (NSCLC). This approach may be more convenient and effective because it shortens treatment time. Another study indicated that this method is safe and effective for older patients with advanced lung cancer. The goal is to deliver stronger radiation doses while reducing side effects, potentially improving survival and quality of life. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with lung cancer who need palliative radiation to manage symptoms or prevent symptom-causing progression. Participants should be able to consent, have a life expectancy over 3 months, and can have other treatments like chemo. They must also be physically stable enough as assessed by the ECOG performance status.

Inclusion Criteria

My doctor expects me to live more than 3 months.

I need radiation for a chest tumor to ease symptoms or prevent them in the next 6 months.

I can care for myself but may not be able to do heavy physical work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive either standard palliative thoracic radiation therapy or hypofractionated, dose-escalated, esophageal-sparing intensity modulated radiation therapy

5-10 fractions

Follow-up

Participants are monitored for overall survival, freedom from intrathoracic progression, quality of life, and toxicity

36 months

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation Therapy
• Radiation Therapy

Trial Overview

The study compares standard palliative thoracic radiation therapy with an advanced technique called hypofractionated dose-escalated IMRT that spares the esophagus. The goal is to see if this new method can deliver higher doses safely and improve survival quality without increasing toxicity.

How Is the Trial Designed?

Group I: Experimental Radiotherapy Experimental Treatment 1 Intervention

35 Gray in 5 fractions

Group II: Standard Radiotherapy Active Control 1 Intervention

20 Gray in 5 fractions or 30 Gray in 10 fractions.

Who Is Running the Clinical Trial?

Chris Goodman

Lead Sponsor

Trials

1

Recruited

140+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11475879/

A Systematic Review of Phase II/III Trials of Hypofractionated ...

There was no evidence that hypofractionation improves survival as compared to conventionally fractionated radiation therapy.

2.

redjournal.org

redjournal.org/article/S0360-3016(25)04238-5/fulltext

Treatment Outcomes of High-Dose Hypofractionated ...

High-dose hypofractionated radiotherapy for NSCLC demonstrated a high local tumor control rate. The regimen of 40 Gy in 10 daily fractions is convenient and ...

3.

jto.org

jto.org/article/S1556-0864(24)02353-0/fulltext

Accelerated Hypofractionated Radiotherapy for Locally ...

Accelerated hypofractionated radiotherapy has gained increasing interest for locally advanced NSCLC, as it can potentially increase ...

4.

ascopubs.org

ascopubs.org/doi/10.1200/GO-25-00153

Hypofractionation for Equitable and Sustainable Cancer Care

HFRT delivers effective cancer treatment by administering larger doses of radiation per session over a shorter overall treatment course, ...

5.

medicaljournalssweden.se

medicaljournalssweden.se/actaoncologica/article/download/43496/50838/161180

Real-world insights into moderately hypofractionated ...

Interpretation: Moderately hypoRT is a safe, feasible, and effective treatment option for elderly and mul- timorbid patients with stage IIB–IIIC ...

6.

e-roj.org

e-roj.org/journal/view.php?number=1647

Efficacy and safety of high-dose hypofractionated palliative ...

With a median follow-up of 4.1 years, the overall response rate was 69.3%. Local control rates at 1 and 3 years were 96.7% and 76.9%, ...

7.

ascopost.com

ascopost.com/news/september-2025/hypofractionated-vs-conventional-radiotherapy-in-phase-iii-trial-for-ls-sclc/

Hypofractionated vs Conventional Radiotherapy in Phase ...

The estimated overall survival rate at 1 year was 86.6%, 68.9% at 2 years, 53.5% at 3 years, and 42.4% at 5 years in the hypofractionated ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0360301624026841

Assessing the Safety and Efficacy of a Hypofractionated ...

Median OS for cenTs was 21.2 months and 18.2 months for UCTs, 95% CI [5.13, 31.76] and [11.77, 31.43] (p = 0.7706). AEFS at 12 months was 68.8%. 2 patients (6.3 ...