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

NCT01512589 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2026-04-15

No results posted yet for this study

Summary

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.

Conditions

  • Esophageal Cancer

Interventions

RADIATION

Proton Beam Therapy (PBT)

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

RADIATION

Intensity Modulated Radiation Therapy (IMRT)

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

BEHAVIORAL

Questionnaires

Symptom and Quality of Life questionnaires completed at baseline, every week during radiation therapy, during break after radiation therapy, and during follow up phase.

Sponsors & Collaborators

Principal Investigators

  • Steven H. Lin, MD,PHD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01512589 on ClinicalTrials.gov