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

21 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well giving a hypofractionated boost to the primary tumor before standard chemotherapy and radiation therapy works in treating patients with stage II or III non-small cell lung cancer that cannot be removed by surgery. Advances in radiation oncology have allowed better radiation targeting which may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells. Giving more precise and targeted radiation before standard chemotherapy and radiation therapy may kill more tumor cells and prevent the cancer from coming back in the location in which it started.

Research Team

Eric Miller, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+