Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies

December 30, 2019 updated by: M.D. Anderson Cancer Center

Phase I Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies

The goal of this clinical research study is to study the safety of giving larger daily doses of proton radiation therapy than the standard dose levels given to treat lung cancer. Researchers want to find the highest daily dose of proton radiation that can be given without having to stop therapy due to side effects.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Proton Therapy:

Proton therapy is a type of radiation that is designed to lower the amount of radiation given to the healthy tissue around the tumor by using a more focused beam of radiation.

Radiation Dose Levels:

If you are found to be eligible to take part in this study, you will be assigned to receive 1 of 3 doses of radiation therapy, based on when you joined the study. The first group of at least 3 participants will receive the lowest total radiation dose. If the first dose is tolerated well by the first group of participants in this study, then the next group of participants will receive the second, higher dose of radiation. If this dose is tolerated, then a third group will be treated at the highest dose.

Practice Visit:

You will have a "practice" radiation visit to plan how the radiation will be given, about 1 week before therapy. This practice visit should take about 1-2 hours. At this visit, you will have a CT scan of the chest that will be used by the study staff to plan your proton therapy. A mold (made of the type of material used for casts) will also be made around your body that will be used to help you remain still during radiation therapy. Marks will be made on your skin to help position your body correctly for the radiation therapy. These marks may be permanent or temporary. If temporary marks are washed off, they will be replaced.

Proton Therapy Visits:

About 1 week after the practice radiation visit, you will begin receiving radiation therapy. At each visit, you will lie down in the mold of your body that was made at the practice visit, and you will be lined up for radiation therapy using the marks made on your skin at the practice visit.

You will receive radiation therapy every weekday (Monday-Friday) for about 3 weeks. Each radiation session should last about 45-60 minutes.

Study Tests:

Each week while you are receiving radiation therapy, you will be asked about any side effects you may be having. Your medical history will be recorded, and you will have a physical exam. If your doctor thinks it is needed, blood (about 2 tablespoons each time) will be drawn for routine tests, and/or you may have CT scans to check the status of the tumor.

Length of Therapy:

You will receive proton radiation therapy for about 3 weeks. The radiation therapy will be stopped early if the disease gets worse or intolerable side effects occur.

Follow-up Visits:

About 6 weeks after your last dose of proton radiation, you will have a CT scan of the chest (with a contrast agent, if possible) and a physical exam.

About 3 months after the first follow-up visit you will have a physical exam, lung function tests, and either a PET/CT scan or CT scan of the chest to check the status of the disease.

Long-term Follow-up:

Every 3 months for the first 2 years after you finish proton therapy, every 6 months for the next 3 years, and 1 time every year after that, you will be asked to return to the clinic for follow-up tests. These tests may include lung function tests, imaging scans (such as a CT or PET/CT scan), and/or an ECG. This will be up to your doctor.

This is an investigational study. At this time, it is considered investigational to give proton radiation therapy at the dose schedule used in this study. This schedule is being used for research purposes only.

Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically or cytologically documented NSCLC, SCLC, thymic tumors, or carcinoid tumors
  2. Patients not receiving concurrent chemotherapy
  3. Patients that are eligible for concurrent treatment with biologic agents (epidermal growth factor receptor [EGFR] or vascular endothelial growth factor [VEGF] inhibitors) will be eligible for the study.

Exclusion Criteria:

  1. Prior radiotherapy to the chest
  2. Life expectancy <6 months
  3. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Proton Therapy
The radiation prescription dose ranges from 45 Gy in 3 Gy fractions to 60 Gy in 4 Gy fractions. Patients will be assigned to receive 1 of 3 doses of radiation therapy, based on when they joined the study. The first group of at least 3 participants will receive the lowest total radiation dose. If the first dose is tolerated well by the first group of participants in this study, then the next group of participants will receive the second, higher dose of radiation. If this dose is tolerated, then a third group will be treated at the highest dose.
Radiation: Proton Therapy
The regimen of 45 Gy in 15 fractions will be delivered as a baseline, and then the fraction size will be escalated in two different intervals of 0.5 Gy each, with the ultimate dose being 60 Gy in 4 Gy fractions.
Other Names:
  • Radiation
  • Radiotherapy
  • XRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose (MTD) of Hypofractionated Proton Therapy
Time Frame: 1 month after completion of radiation therapy
Dose-limiting toxicity (DLT) defined as any CTCAE v4.0 grade 4 complication of esophagus or skin, or any grade 3 or higher complications of other organ systems (i.e. lung, liver, kidney, or GI tract), unless these complications are deemed to be related to those of esophagus. DLT assessed within 1 month of completion of radiation therapy. MTD defined as highest dose for which probability of toxicity is closest to 25%.
1 month after completion of radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Daniel Gomez, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2010

Primary Completion (Actual)

July 19, 2016

Study Completion (Actual)

July 19, 2016

Study Registration Dates

First Submitted

July 16, 2010

First Submitted That Met QC Criteria

July 16, 2010

First Posted (Estimate)

July 20, 2010

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 30, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-0164
  • NCI-2012-01780 (Registry Identifier: NCI CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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