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Radiation
Pre-Chemoradiation Hypofractionated Radiation for Lung Cancer
Phase 2
Waitlist Available
Led By Eric Miller, MD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary tumor control rate, as measured from the time of treatment completion until the first documented date of local failure
Secondary outcome measures
Changes in diffusion measured by MR-diffusion
Changes in hypoxia measured by BOLD sequences
Changes in tumor perfusion measured by MR-DCE/PWI
+7 moreTrial 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
Etoposide
FDA approved
hypofractionated radiation therapy
2008
Completed Phase 3
~290
Cisplatin
FDA approved
3-dimensional conformal radiation therapy
2007
Completed Phase 3
~2690
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,146 Total Patients Enrolled
Eric Miller, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Terence Williams, MD, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
16 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I had a chest surgery over 3 weeks ago and have healed well.I have had radiation therapy before in the same area.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.Your hemoglobin level is at least 9 grams per deciliter.Your platelet count is at least 100 billion per liter.Your AST and ALT levels should be less than or equal to 2.5 times the upper limit of normal.I have cancer nodules in the same or nearby lung lobe, not exceeding 6 cm.I have a history of scleroderma or idiopathic pulmonary fibrosis.I have small fluid build-ups not visible on an X-ray and too minor to drain.My lung cancer is confirmed to be non-small cell type.My condition cannot be treated with surgery.My primary tumor is 6 cm or smaller.My tests show no cancer cells in the fluid from my chest.My organs are functioning well, as confirmed by tests within the last 30 days.Women who could become pregnant must have a negative pregnancy test within 14 days of joining the study. A urine test for human gonadotropin (HCG) can be used to check for pregnancy.I do not have severe uncontrolled nerve pain or damage.You cannot have an MRI scan if you have a pacemaker, metal implants, aneurysm clips, allergy to contrast dye, are pregnant, nursing, or weigh more than 350 pounds.I am fully active or restricted in physically strenuous activity but can do light work.I have cancerous nodules in the opposite lobe of my lung.All my side effects from previous treatments are mild, except for hair loss.My cancer has spread to other parts of my body.I've had specific scans within the last 2 months for my condition.My cancer has spread to the lymph nodes on the opposite side of my chest.My lung cancer is at an early to mid-stage but hasn't spread to distant organs.I haven't had chemotherapy or targeted cancer drugs in over 2 years.My lung cancer can be measured and is not undetectable.Your white blood cell count is at least 1.5 billion per liter.I am using or willing to use birth control or practice abstinence during the study.My kidney function, measured by creatinine levels, is within the normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (hypofractionated radiation boost, chemoradiation)
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA sanction hypofractionated radiation therapy?
"Our experts graded hypofractionated radiation therapy's safety at a score of 2 based on the Phase 2 trial data, which contains some evidence of its security but nothing to validate its efficacy."
Answered by AI
How many subjects are participating in this experiment?
"Unfortunately, this study is not currently enrolling individuals. It was initially posted on December 8th 2014 and last modified on November 24th 2020. If you are seeking alternative clinical trials, there are 1,908 studies actively searching for patients with non-small cell lung carcinoma as well as 901 trials looking to recruit participants that could benefit from hypofractionated radiation therapy."
Answered by AI
What maladies are most commonly managed with hypofractionated radiation therapy?
"Advance directives are typically addressed with hypofractionated radiation therapy, which is also useful for treating Merkel cell cancer, neoplasm metastasis and prostate cancer."
Answered by AI
Is recruitment for this trial still available?
"This research project is no longer in the process of recruiting participants, as it was last updated on November 24th 2020. If you are looking for additional studies to join, there are 1908 medical trials that involve non-small cell lung carcinoma and 901 clinical investigations into hypofractionated radiation therapy actively enrolling patients currently."
Answered by AI
Could you provide insight into other experiments that have explored hypofractionated radiation therapy?
"Presently, a total of 901 clinical trials involving hypofractionated radiation therapy are in progress, with 325 studies at the Phase 3 stage. A bulk of these research projects are located within New york City but there is also an abundance of sites scattered across 50938 locations to conduct this investigation."
Answered by AI
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