Proton Beam Therapy vs. IMRT for Esophageal Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Steven H. Lin | MD Anderson Cancer Center

Overseen bySteven H. Lin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The goal of this clinical research study is to learn how safe and effective proton-beam therapy (PBT) may be in comparison to intensity modulated radiation therapy (IMRT) in combination with chemotherapy in patients with esophageal cancer. PBT and IMRT are both forms of radiation therapy that are designed to treat a specific area of the body while affecting as little of the surrounding normal tissue as possible. PBT is a newer technology that is designed to further reduce the amount of radiation that affects the surrounding normal tissue. However, this is still being studied.

Eligibility Criteria

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.

Inclusion Criteria

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

Able to communicate in the English language

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

+8 more

Exclusion Criteria

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

I have another cancer, but treating my esophageal cancer is the priority.

I have had radiation without chemo or chemo alone.

+1 more

Participant Groups

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.

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).