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Radiation

Pre-Chemoradiation Hypofractionated Radiation for Lung Cancer

Phase 2

Waitlist Available

Led By Terence Williams, MD, PhD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

If a pleural effusion is present and visible on both CT scan AND chest x-ray, the investigator should exclude malignant disease by pleurocentesis to confirm cytologically-negative pleural fluid; if fluid is exudative or cytologically positive for tumor cells, patient is excluded

Patients with effusions that are minimal (i.e. not visible on chest x-ray) and that are too small to safely tap are eligible

Must not have

Patients with history of pneumonectomy

History of previous radiation therapy which would result in overlapping radiation fields

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is testing whether targeted radiation to the primary tumor before standard chemo and radiation therapy can help treat patients with stage II or III non-small cell lung cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include damage to nearby healthy tissue from radiation, fatigue, nausea from chemotherapy drugs cisplatin and etoposide, as well as potential blood disorders like low white blood cell counts which could increase infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My tests show no cancer cells in the fluid from my chest.

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I have small fluid build-ups not visible on an X-ray and too minor to drain.

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My lung cancer is confirmed to be non-small cell type.

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My condition cannot be treated with surgery.

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My primary tumor is 6 cm or smaller.

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All my side effects from previous treatments are mild, except for hair loss.

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I've had specific scans within the last 2 months for my condition.

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My lung cancer is at an early to mid-stage but hasn't spread to distant organs.

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My lung cancer can be measured and is not undetectable.

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My kidney function, measured by creatinine levels, is within the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a lung removed.

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I have had radiation therapy before in the same area.

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I have a history of scleroderma or idiopathic pulmonary fibrosis.

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I do not have severe uncontrolled nerve pain or damage.

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I have cancerous nodules in the opposite lobe of my lung.

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My cancer has spread to other parts of my body.

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My cancer has spread to the lymph nodes on the opposite side of my chest.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary tumor control rate, as measured from the time of treatment completion until the first documented date of local failure

Secondary study objectives

Changes in diffusion measured by MR-diffusion

Changes in hypoxia measured by BOLD sequences

Changes in tumor perfusion measured by MR-DCE/PWI

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (hypofractionated radiation boost, chemoradiation)Experimental Treatment5 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

FDA approved

hypofractionated radiation therapy

2008

Completed Phase 3

~290

3-dimensional conformal radiation therapy

2007