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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01468 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 9148 | Other Identifier | University of Washington | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies proton beam radiation therapy in treating patients with thoracic cancer that has come back and have received prior radiation therapy. Proton beam radiation therapy uses high energy protons to kill tumor cells and may cause less damage to normal tissue.
PRIMARY OBJECTIVES:
I. To assess the grade 3 toxicity associated with thoracic re-irradiation with proton therapy, with prospectively applied normal organ radiation dose limits.
SECONDARY OBJECTIVES:
I. To assess the efficacy of thoracic re-irradiation with proton therapy.
OUTLINE:
Patients undergo proton beam radiation therapy per standard of care.
After completion of study treatment, patients are followed up at 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Proton beam radiation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Beam Radiation Therapy | Radiation | Undergo proton beam re-irradiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment | Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 generally means hospitalization required for management of side effects. | Up to 3 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment | Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. Grade 2 generally means medical therapy required to intervene due to toxicity. | Up to 3 months post-treatment |
| Number of Participants With Local Control of Cancer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Zeng | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Proton Beam Radiation Therapy) | Patients undergo proton beam radiation therapy per standard of care. Proton Beam Radiation Therapy: Undergo proton beam radiation therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Proton Beam Radiation Therapy) | Patients undergo proton beam radiation therapy per standard of care. Proton Beam Radiation Therapy: Undergo proton beam radiation therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment | Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 generally means hospitalization required for management of side effects. | Posted | Count of Participants | Participants | Up to 3 months post-treatment |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Proton Beam Radiation Therapy) | Patients undergo proton beam radiation therapy per standard of care. Proton Beam Radiation Therapy: Undergo proton beam radiation therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jing Zeng | University of Washington Medical Center | 2065984110 | jzeng13@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2015 | Oct 7, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D013899 | Thoracic Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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Number of participants who did not have local failure as defined by: tumor progression per Response Evaluation Criteria in Solid Tumors criteria - at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions inside the full dose radiation field. |
| Up to 3 months post-treatment |
| Number of Participants Alive | Number of participants alive. | Up to 3 months post-treatment |
| ProCure Proton Therapy Center-Seattle |
| Seattle |
| Washington |
| 98133 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of participants with Grade 3+ toxicity from radiation | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment | Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. Grade 2 generally means medical therapy required to intervene due to toxicity. | Posted | Count of Participants | Participants | Up to 3 months post-treatment |
|
|
|
| Secondary | Number of Participants With Local Control of Cancer | Number of participants who did not have local failure as defined by: tumor progression per Response Evaluation Criteria in Solid Tumors criteria - at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions inside the full dose radiation field. | Posted | Count of Participants | Participants | Up to 3 months post-treatment |
|
|
|
| Secondary | Number of Participants Alive | Number of participants alive. | Posted | Count of Participants | Participants | Up to 3 months post-treatment |
|
|
|
| 0 |
| 6 |
| 2 |
| 6 |
| 0 |
| 6 |
| Pain | Nervous system disorders | Non-systematic Assessment |
|
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| D009369 | Neoplasms |