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Intensity Modulated Radiation Therapy

Proton Beam Therapy vs. IMRT for Esophageal Cancer

Phase 2

Waitlist Available

Led By Steven H. Lin, MD,PHD

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

Prior Endoscopic Mucosal Resection (EMR) with a diagnosis of stage II-III esophageal cancer is eligible

Performance status of Karnofsky Performance Scale (KPS) >/= 60 or Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2

Must not have

Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease including but not limited to: a) active uncontrolled infection; b) Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device; c) no myocardial infarction within 3 months of registration

Radiation treatment alone without concurrent chemotherapy or chemotherapy use alone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare PBT to IMRT to see if PBT is more effective and has fewer side effects.

Who is the study for?

Adults over 18 with esophageal cancer, who can communicate in English and have a performance status indicating they are able to carry out some activity. They must not be pregnant or breastfeeding, should agree to use contraception, and cannot have active stage 4 cancers or uncontrolled major diseases. Prior treatments like chemotherapy are allowed if there's little overlap with the new treatment area.

What is being tested?

The trial is testing the safety and effectiveness of Proton Beam Therapy (PBT) versus Intensity-Modulated Radiation Therapy (IMRT), both combined with chemotherapy. PBT is newer and may reduce radiation damage to surrounding tissue compared to IMRT; this study aims to confirm that.

What are the potential side effects?

Potential side effects for both PBT and IMRT include skin changes at the treatment site, fatigue, difficulty swallowing, nausea, weight loss due to eating difficulties, lung inflammation leading to coughing or shortness of breath.

Eligibility Criteria

Inclusion Criteria

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

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I had a procedure to remove cancer from my esophagus and it was stage II-III.

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I can care for myself but may not be able to do active work.

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My cancer is in the esophagus, gastroesophageal junction, or stomach and has been confirmed by a biopsy.

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I am 18 years old or older.

Exclusion Criteria

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

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I do not have any major uncontrolled health issues like heart failure or recent heart attack.

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I have had radiation without chemo or chemo alone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

Progression-Free Survival (PFS)

Total Toxicity Burden (TTB)

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

Active Control

Group I: Proton Beam Therapy (PBT)Experimental Treatment2 Interventions

Radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy (or at RBE ("Relative Biologic Equivalence" for PBT)) to be delivered to the periphery of the planning target volume (PTV).

Group II: Intensity Modulated Radiation Therapy (IMRT)Active Control2 Interventions

Radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy to be delivered to the periphery of the planning target volume (PTV).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Questionnaires

2013

Completed Phase 2

~4280

0 / 6Eligibility criteria met