Proton Beam Therapy vs. Intensity-Modulated Radiation Therapy for Esophageal Cancer

Program Overview

The purpose of this study is to find out how safe and effective Proton Beam Therapy (PBT) is compared to Intensity-Modulated Radiation Therapy (IMRT) when used with chemotherapy in patients with esophageal cancer. Both PBT and IMRT are types of radiation therapy that target cancer cells while trying to minimize damage to surrounding healthy tissue. PBT is a newer technology that may reduce radiation exposure to normal tissue even further, but more research is needed to confirm this.

Description

Study Treatment:

If you qualify for this study, you will be randomly placed into one of two groups:

• Group 1 will receive IMRT.
• Group 2 will receive PBT.

You will undergo radiation therapy once a day, five days a week (Monday through Friday) for up to 28 sessions.

Your doctor might also recommend chemotherapy during your radiation treatment. If so, you will need to sign a separate consent form explaining the chemotherapy process and its risks.

Study Visits:

Before starting radiation therapy, you will have a baseline visit that includes:

• Blood tests (about 1-2 tablespoons) for routine checks.
• Recording of your performance status.
• A PET/CT or CT scan to assess the cancer.
• Lung function tests.
• Symptom and quality of life questionnaires.
• An endoscopic examination of your esophagus, possibly with a biopsy if needed.

You will have weekly study visits during radiation therapy, which will include:

• Recording your medical history.
• A physical exam.
• Recording your performance status, weight, and vital signs.
• Blood tests (about 1-2 tablespoons) for routine checks.
• Completing symptom and quality of life questionnaires.

Length of Study:

Radiation therapy will last for up to 28 sessions (about 5½ weeks). You will stop receiving radiation if the cancer worsens, if side effects become intolerable, or if you cannot follow study instructions.

Your participation will end after completing follow-up visits.

Follow-Up:

After radiation therapy, there will be a 4-6 week break. During this time, you will be contacted twice a week to complete symptom and quality of life questionnaires via phone calls.

About 4-6 weeks after finishing radiation therapy, you will have follow-up tests and procedures, including:

• Recording your medical history.
• A physical exam.
• Recording your performance status, weight, and vital signs.
• A PET/CT scan to assess the cancer.
• Lung function tests.
• Blood tests (about 1-2 tablespoons) for routine checks.
• Completing symptom and quality of life questionnaires.
• An endoscopic examination of your esophagus, possibly with a biopsy if needed.

If your doctor recommends surgery to remove the tumor after radiation therapy, you will sign a separate consent form for the procedure and its risks. The study doctor will monitor you for side effects after surgery.

You will have follow-up visits every 3-4 months for 2 years, then every 4-6 months for the next 3 years, which will include:

• Recording your medical history.
• A physical exam.
• Recording your performance status, weight, and vital signs.
• A CT or PET/CT scan to assess the cancer.
• Completing symptom and quality of life questionnaires (unless the cancer worsens).

Additional tests may be performed during follow-up visits if needed, such as blood tests, lung function tests, and endoscopic examinations with possible biopsy.

You may be contacted by the study staff about your health, even if you choose not to return for follow-up visits after treatment.

This study is investigational. Both IMRT and PBT are FDA-approved and commercially available, but comparing them is investigational.

Up to 180 patients will participate, all at MD Anderson.

Eligibility Criteria

Locations