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Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01165658
Recruitment Status : Active, not recruiting
First Posted : July 20, 2010
Last Update Posted : January 11, 2019
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Small Cell Lung Cancer Carcinoid Thymic Cancer Lung Cancer Radiation: Proton Therapy Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies
Actual Study Start Date : July 2010
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

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
  • XRT
  • Radiotherapy

Primary Outcome Measures :
  1. 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%.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01165658

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Daniel Gomez, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01165658     History of Changes
Other Study ID Numbers: 2010-0164
NCI-2012-01780 ( Registry Identifier: NCI CTRP )
First Posted: July 20, 2010    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

Keywords provided by M.D. Anderson Cancer Center:
non-small cell lung cancer
small cell lung cancer
thymic cancer
lung cancer
radiation therapy
proton therapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Carcinoid Tumor
Thymus Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Lymphatic Diseases