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Radiation Therapy
Image-Guided Radiation Therapy for Lung Cancer
Phase 1 & 2
Recruiting
Led By Zhongxing Liao
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status (KPS) score >= 70
Adequate lung function indicated by forced expiratory volume at 1 second (FEV1) >= 1 L is required
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new way of delivering radiation dose by image-guided, intensity-modulated photon or proton beam radiation therapy to patients with stage II-IIIB non-small cell lung cancer.
Who is the study for?
This trial is for adults with stage II-IIIB non-small cell lung cancer that hasn't been removed by surgery or has come back after surgery or SBRT. They must be able to handle chemo, have a KPS score of at least 70, stable weight, and good blood counts and organ function. Pregnant individuals or those who can't use contraception are excluded.Check my eligibility
What is being tested?
The study compares two advanced radiation therapies: intensity-modulated photon beam therapy (using X-rays) and proton beam therapy (using protons). It aims to deliver higher doses directly to the tumor while protecting healthy tissue. Participants will also undergo motion management during treatment.See study design
What are the potential side effects?
Potential side effects include skin reactions at the treatment site, fatigue, difficulty swallowing if treating near the esophagus, shortness of breath due to lung inflammation, and other typical radiation-related symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself but may not be able to do active work.
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My lung function is good, with an FEV1 of at least 1 liter.
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I have not had radiation therapy targeting the area around my heart and lungs.
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My lung cancer is at stage II-IIIB, or has come back after surgery or targeted radiation.
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
Local progression-free survival (75% at 6 months) d (Phase II)
MTD for intensity-modulated proton therapy (IMPT) (Phase I)
Maximum tolerated dose (MTD) for intensity-modulated photon therapy (IMRT) (Phase I)
+1 moreSecondary outcome measures
Change in symptom burden using European Quality of Life Five Dimension [EQ-5D]) (Phase II) Survey
Change in symptom burden using MD Anderson Symptom Inventory [MDASI]-Plus Survey
Changes in selected biomarkers (Phase II)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (image-guided IMPT)Experimental Treatment5 Interventions
Patients undergo image-guided IMPT SIB QD 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (image-guided IMRT)Experimental Treatment5 Interventions
Patients undergo image-guided IMRT SIB QD 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Image Guided Radiation Therapy
2016
Completed Phase 2
~20
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Proton Beam Radiation Therapy
2013
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,261 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,926,098 Total Patients Enrolled
Zhongxing LiaoPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
430 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had radiation that could affect my heart, spine, or esophagus.I have chosen not to participate in this trial.My doctor thinks I can handle both chemotherapy and radiation at the same time.Your liver enzymes (ALT and AST) are not more than 2.5 times the normal level, or not more than 5 times the normal level if you have liver involvement.I am able to care for myself but may not be able to do active work.I've had initial chemotherapy and was then referred for combined chemotherapy and radiation.My lung function is good, with an FEV1 of at least 1 liter.My cancer's movement can be managed and tracked with specific CT scans, meeting the study's requirements.I have not had radiation therapy targeting the area around my heart and lungs.My lung cancer is at stage II-IIIB, or has come back after surgery or targeted radiation.Your bilirubin levels are not higher than 1.5 times the upper limit of normal.Your creatinine level is not more than 1.5 times the upper limit of normal.Your platelet count is at least 100,000 per cubic millimeter.Your hemoglobin level is at least 9.0 grams per deciliter.I have lost less than 15% of my weight in the 3 months before my diagnosis.My cancer has spread to my esophagus, spinal cord, major blood vessels, or heart.Your doctor can see the main tumor and nearby lymph nodes on a scan.You have enough infection-fighting white blood cells in your body.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (image-guided IMRT)
- Group 2: Arm II (image-guided IMPT)
Awards:
This trial has 1 awards, including:- 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.
What results are investigators hoping to yield from this clinical investigation?
"The primary goal of this 6-month study is to identify the Maximum Tolerated Dose (MTD) for intensity modulated photon therapy (IMRT). Secondary outcomes include a change in symptom burden, evaluated through European Quality of Life Five Dimension [EQ-5D]) and MD Anderson Symptom Inventory [MDASI]-Plus Surveys via descriptive statistics and box plots. Additionally, progression free survival will be assessed using Kaplan and Meier's product limit estimator."
Answered by AI
How many individuals have enrolled in this research initiative?
"Affirmative. According to clinicaltrials.gov, the trial is actively searching for volunteers; it was initially posted on September 17th 2012 and was last updated June 15th 2021. 100 individuals must be recruited from a single site."
Answered by AI
Are there current opportunities for participation in this research project?
"Indeed, according to clinicaltrials.gov's records, this medical study is actively recruiting participants. The trial was launched on September 17th 2012 and updated last June 15th 2021. One hundred volunteers are required at one location for the duration of the research."
Answered by AI
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