Hypofractionated Proton Radiation Therapy
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01165658
First received: July 16, 2010
Last updated: August 14, 2012
Last verified: August 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer Small Cell Lung Cancer Carcinoid Thymic Cancer Lung Cancer |
Radiation: Proton Therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- CT Scans to Check the Status of the Tumor [ Time Frame: 6 weeks after last dose of proton radiation and 3 months after the first follow-up visit ] [ Designated as safety issue: No ]6 weeks after last dose of proton radiation, and 3 months after the first follow-up visit, either a PET/CT scan or CT scan of the chest will be performed.
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165658
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Daniel Gomez, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01165658 History of Changes |
| Other Study ID Numbers: | 2010-0164 |
| Study First Received: | July 16, 2010 |
| Last Updated: | August 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
non-small cell lung cancer NSCLC small cell lung cancer SCLC carcinoid |
thymic cancer lung cancer radiation therapy radiotherapy proton therapy |
Additional relevant MeSH terms:
|
Carcinoid Tumor Carcinoma, Non-Small-Cell Lung Lung Neoplasms Thymus Neoplasms Small Cell Lung Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Lymphatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013