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Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies

Primary Purpose

Non-small Cell Lung Cancer, Small Cell Lung Cancer, Carcinoid

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Proton Therapy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring non-small cell lung cancer, NSCLC, small cell lung cancer, SCLC, carcinoid, thymic cancer, lung cancer, radiation therapy, radiotherapy, proton therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD) of Hypofractionated Proton 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%.

Secondary Outcome Measures

Full Information

First Posted
July 16, 2010
Last Updated
December 30, 2019
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01165658
Brief Title
Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies
Official Title
Phase I Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Requested by PI during yearly Continuing Review
Study Start Date
July 16, 2010 (Actual)
Primary Completion Date
July 19, 2016 (Actual)
Study Completion Date
July 19, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Small Cell Lung Cancer, Carcinoid, Thymic Cancer, Lung Cancer
Keywords
non-small cell lung cancer, NSCLC, small cell lung cancer, SCLC, carcinoid, thymic cancer, lung cancer, radiation therapy, radiotherapy, proton therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proton Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Proton Therapy
Other Intervention Name(s)
Radiation, XRT, Radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) of Hypofractionated Proton Therapy
Description
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%.
Time Frame
1 month after completion of radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically documented NSCLC, SCLC, thymic tumors, or carcinoid tumors Patients not receiving concurrent chemotherapy 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: Prior radiotherapy to the chest Life expectancy <6 months Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Gomez, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies

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