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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01449 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 14-001086 | Other Identifier | UCLA / Jonsson Comprehensive Cancer Center | |
| P30CA016042 | 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 the feasibility of palliative 4pi radiotherapy in treating patients with glioblastoma multiforme that has come back after standard chemoradiation. A new radiotherapy delivery planning system, called 4pi radiotherapy, may help improve radiation delivery by improving dose coverage to the treatment target, while reducing the dose to surrounding normal tissues.
PRIMARY OBJECTIVES:
I. To determine the accuracy of dose delivery and patient comfort with treatment time.
II. To evaluate normal tissue dose volume statistics and compare to standard planning.
OUTLINE:
Patients undergo 4pi radiation simulation and planning followed by 5 to 10 daily fractions of 4pi palliative radiotherapy. If an acceptable plan cannot be achieved using 4pi planning, then the patient will be treated with standard radiation therapy planning for palliative re-irradiation.
After completion of study treatment, patients are followed up at 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (4pi radiotherapy) | Experimental | Patients undergo 4pi radiation simulation and planning followed by 5 to 10 daily fractions of 4pi palliative radiotherapy. If an acceptable plan cannot be achieved using 4pi planning, then the patient will be treated with standard radiation therapy planning for palliative re-irradiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative Radiation Therapy | Radiation | Undergo 4pi palliative radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of dose delivery | The accuracy of dose delivery by 4pi will be compared to standard procedures. Standard quality assurance (QA) procedures will be employed to validate the delivery accuracy of 4pi. Specifically, a MatriXX phantom will be employed to measure the dose in both the coronal and sagittal planes and compared to calculation. Patients with QA results showing gamma passing rates (using 3% and 3 mm dose difference and distance to agreement criteria, respectively) less than 90% in either plane or a maximum single gamma value greater than 2 will not be treated until the source of error is corrected. | Up to 6 weeks |
| Normal tissue dose volume | Statistics will be compared between 4pi and standard planning. Specifically, dose to organs-at-risk (OAR) and planning target volume (PTV) coverage will be compared to assess for improved OAR sparing and improved PTV coverage with 4pi planning. | Up to 6 weeks |
| Patient comfort with treatment time, determined by a patient-completed questionnaire completed at the end of each fraction | Up to 10 days |
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Inclusion Criteria:
Histologically confirmed primary glioblastoma multiforme (GBM)
Patient must have previously undergone standard chemoradiation- 59.4 Gy (1.8 Gy/fraction) or 60 Gy (2.0 Gy/fraction) with concurrent and adjuvant Temodar (temozolomide)
Patient must be diagnosed with recurrent GBM either with biopsy or radiographically
Karnofsky Performance Status (KPS) >= 70
Ability to understand and willingness to sign a written informed consent
If a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study treatment and for up to 4 weeks following the study treatment
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tania Kaprealian | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 12, 2021 | |
| Reset | Jun 7, 2021 |
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| Questionnaire Administration | Other | Ancillary studies |
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| Radiation Therapy Treatment Planning and Simulation | Radiation | Undergo 4pi radiation simulation and planning |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 12, 2021 | Jun 7, 2021 |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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