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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
Must not have
Prior radiotherapy to any anatomic regions that would result in overlap of radiation dose distribution to critical structures (esophagus, heart, spinal cord, brachial plexus)
Patient refusal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had radiation that could affect my heart, spine, or esophagus.
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I have chosen not to participate in this trial.
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My cancer has spread to my esophagus, spinal cord, major blood vessels, or heart.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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)
Secondary study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
~2140
Proton Beam Radiation Therapy
2013
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,546 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,938 Total Patients Enrolled
Zhongxing LiaoPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
430 Total Patients Enrolled

Media Library

Image Guided Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01629498 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Arm I (image-guided IMRT), Arm II (image-guided IMPT)
Non-Small Cell Lung Cancer Clinical Trial 2023: Image Guided Radiation Therapy Highlights & Side Effects. Trial Name: NCT01629498 — Phase 1 & 2
Image Guided Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01629498 — Phase 1 & 2
~6 spots leftby Sep 2025
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