Pre-Chemoradiation Hypofractionated Radiation for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ohio State University Comprehensive Cancer Center

Must not be taking: Erlotinib, Crizotinib

Disqualifiers: Metastatic disease, Pneumonectomy, AIDS, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to treating stage II or III non-small cell lung cancer that cannot be removed with surgery. Researchers are testing whether a precise form of radiation therapy, administered before standard chemotherapy and radiation, can better target tumors and reduce damage to healthy tissue. The treatment combines advanced radiation techniques, including 3-dimensional conformal radiation therapy, with chemotherapy drugs cisplatin and etoposide to halt cancer growth. This trial may suit those diagnosed with this type of lung cancer who cannot undergo surgery. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that hypofractionated radiation therapy, which involves delivering radiation in larger doses over fewer sessions, is generally safe for treating lung cancer. Studies indicate it effectively controls the cancer while minimizing harm to healthy tissue. Although serious side effects like lung inflammation (radiation pneumonitis) and heart damage (cardiotoxicity) can occur, they are uncommon.

The chemotherapy drugs cisplatin and etoposide have long been used in cancer treatment and effectively stop cancer cell growth. However, like most chemotherapy drugs, they can cause side effects, ranging from nausea and hair loss to more serious issues like low blood cell counts. Their safety has been well-researched, and doctors closely monitor patients to manage any side effects.

As this is a Phase 2 trial, the treatment has undergone earlier testing for some level of safety, but researchers continue to collect data to confirm its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment for lung cancer because it combines a hypofractionated radiation boost with chemoradiation, potentially enhancing the effectiveness of traditional radiation therapy. This approach allows for higher doses of radiation over fewer sessions, which could lead to faster results and possibly better tumor control. Additionally, the combination with chemotherapy drugs like Cisplatin and Etoposide aims to improve the overall response by attacking the cancer in multiple ways. This innovative method might offer a more efficient and potentially more effective treatment option compared to standard treatments that often involve longer, more spread-out schedules.

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

This trial will evaluate hypofractionated radiation therapy, which uses higher doses of radiation in fewer sessions, for treating advanced non-small cell lung cancer (NSCLC). Research has shown that this method can be as effective as traditional radiation, making it a viable option for patients. Although it may not increase survival rates compared to conventional methods, it effectively controls the tumor. Additionally, precise targeting of radiation may reduce harm to healthy tissue. In this trial, hypofractionated radiation will be combined with chemotherapy drugs like cisplatin and etoposide, which stop cancer cells from growing, to potentially enhance the overall treatment effect. ^{1 4 6 7 8}

Who Is on the Research Team?

Eric Miller, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with stage II-III non-small cell lung cancer that can't be removed by surgery. They must have a measurable tumor, normal organ function, and no severe health issues like heart failure or uncontrolled neuropathy. Women who can bear children need a negative pregnancy test and must not breastfeed during the trial.

Inclusion Criteria

I had a chest surgery over 3 weeks ago and have healed well.

I've had recent health checks including blood tests and, if applicable, a pregnancy test.

Your total bilirubin level is not more than 1.5 times the upper limit of normal.

Exclusion Criteria

I have had a lung removed.

I have no other cancers except for certain skin, bladder, or cervical cancers, or any cancer I had is in remission for 3+ years.

Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator; this could include severe, active co-morbidities such as: Unstable angina and/or congestive heart failure requiring hospitalization within the last months, Transmural myocardial infarction within the last 6 months, Acquired immune deficiency syndrome (AIDS) based upon the current CDC definition; note, however, that HIV testing is not required for entry to protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved may be significantly immunosuppressive, Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration, Hepatic insufficiency resulting in jaundice and/or coagulation defects

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Hypofractionated Radiation Boost

Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1

1 week

2 visits (in-person)

Chemoradiation

Patients receive cisplatin and etoposide with standard conformal radiation therapy for 6 weeks

6 weeks

5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Every 3 months for 2 years, then every 6 months for 3 years

What Are the Treatments Tested in This Trial?

Interventions

• 3-dimensional conformal radiation therapy
• Cisplatin
• Etoposide
• Hypofractionated Radiation Therapy

Trial Overview The study tests if giving targeted radiation (hypofractionated boost) before standard chemo (cisplatin and etoposide) and radiation therapy improves outcomes in these patients. The goal is to see if this approach kills more cancer cells and prevents recurrence better than current methods.

How Is the Trial Designed?

Group I: Treatment (hypofractionated radiation boost, chemoradiation) Experimental Treatment 5 Interventions

Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11215506/

exploring efficacy and safety - Part 2. Lung (non-small cell ... HFRT has demonstrated promising results, and the reviewed data support its feasibility and comparable efficacy for the treatment of locally advanced NSCLC.

2. 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.

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. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2823972

Stereotactic vs Hypofractionated Radiotherapy for ... In this randomized clinical trial, SBRT resulted in acceptable tumor control compared with CRT with limited toxic effects.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0360301624026506

2060 Accelerated Hypofractionated Radiotherapy for the ... The median OS for hypo-RT alone (reported by 10 studies) was 13.6 months (6-46), while the 1-, 2-, and 3-year OS was 77.2% (38-98), 50.9% (38-85), and 32.1% (29 ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525730425001482

Factors Associated with Local Control and Toxicity of ... Hypofractionated radiation therapy offers excellent local control and low toxicity. Severe toxicities include radiation pneumonitis, cardiotoxicity, and ...

7. mdpi.com mdpi.com/2072-6694/16/19/3384

A Systematic Review of Phase II/III Trials ... There was no evidence that hypofractionation improves survival as compared to conventionally fractionated radiation therapy.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02720614

Study Details | NCT02720614 | Hypofractionated Radiation ... The purpose of this study is to evaluate the safety of accelerated hypofractionated three-dimensional conformal radiation therapy (3 Gy/fraction) concurrent ...