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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-Free Survival (PFS)

Total Toxicity Burden (TTB)

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

~3330

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER

2,928 Previous Clinical Trials

13,198,208 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,634 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,006 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings in this experiment?

"The information on the clinicaltrials.gov website attests that this medical trial is not actively recruiting patients at present. Initially posted on April 1st 2012 and last updated October 11th 2022, there are 377 other trials searching for participants to join them instead."

Answered by AI

Has Proton Beam Therapy (PBT) attained the necessary regulatory clearances?

"Our team evaluated Proton Beam Therapy's (PBT) safety, and since this is a Phase 2 trial with evidence of safety but no evidence of efficacy yet, it was assigned a rating of 2."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Randomized Phase IIB Trial of Proton Beam Therapy Versus Intensity-modulated Radiation Therapy for Locally Advanced Esophageal Cancer

Lin, Steven H., Brian P. Hobbs, Vivek Verma, Rebecca S. Tidwell, Grace L. Smith, Xiudong Lei, Erin M. Corsini, et al.. 2020. “Randomized Phase IIB Trial of Proton Beam Therapy Versus Intensity-modulated Radiation Therapy for Locally Advanced Esophageal Cancer”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.19.02503.

clinicaltrials.govStudy

Proton Beam Therapy (PBT) Versus Intensity-Modulated Radiation Therapy (IMRT) Trial

2012. "Proton Beam Therapy (PBT) Versus Intensity-Modulated Radiation Therapy (IMRT) Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01512589.

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