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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA159547 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Northwestern University | OTHER |
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies intensity-modulated radiation therapy (IMRT) in treating younger patients with lung metastases. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
OBJECTIVES:
I. To demonstrate the feasibility of delivering cardiac-sparing IMRT in a multi-institutional setting with central quality control for children and young adults with metastatic tumors in the lungs.
II. To prospectively determine the dosimetric advantages of whole lung IMRT treatment over standard whole lung irradiation by comparing treatment plans and different organ dose-volume histograms such as lungs, heart, thyroid gland, liver etc. in all patients enrolled in this study.
III. To determine the short-term efficacy (lung-metastases free survival) and acute tolerance of whole lung IMRT at a minimum period of six months after IMRT.
OUTLINE:
Patients undergo cardiac-sparing whole lung IMRT.
After completion of study treatment, patients are followed up for 1-5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (IMRT) | Experimental | Patients undergo cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensity-modulated radiation therapy | Radiation | Undergo cardiac-sparing whole lung IMRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Delivering Cardiac-sparing IMRT With Central Quality Control in 20 Subjects | Feasibility is defined as an enrolled patient receiving the IMRT treatment as stipulated in the protocol. Feasibility of delivering whole lung IMRT will be demonstrated by obtaining central (Quality Assurance Review Center 'QARC') quality control approval of enrolled patient treatment plans according to the protocol guidelines for the 20 subjects enrolled onto the study. If an enrolled patient did not receive the IMRT treatment as stipulated in the protocol this subject then the treatment will be considered not feasible in this patient. | All IMRT treatment plans were centrally reviewed within 1-2 days of receipt of the radiation therapy plan. The feasibility was determined as 'feasible' if deemed in accordance with protocol guidelines after central QARC review within 1-2 days of receipt. |
| Short-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease) | Serial CT scans of the chest were examined to determine lung-metastasis free survival | From date of enrollment until the date of first documented progression, relapse or date of death from any cause up to an average of 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage Radiation Dose to Organ Volumes | The IMRT and standard anteroposterior (AP-PA) treatment plans were reviewed and compared for target coverage and organ dose-volume histograms. The mean percentage volume of the organ or organ sub-region receiving a percentage of the dose was estimated from the computerized treatment plans for these two techniques were estimated and compared statistically |
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Inclusion Criteria:
Patients may have a Wilms tumor, Ewing Sarcoma, Rhabdomyosarcoma or any other metastatic pediatric malignancy; patients may have a single or multiple pulmonary metastases at the time of diagnosis or at the time of recurrence; a pulmonary metastasis may be defined as one pulmonary nodule >= 1 cm or more than one pulmonary nodules >= 0.5 cm; a biopsy of the nodules may be considered in case of doubt
The Karnofsky performance status must be >= 50 for patients > 16 years of age and the Lansky performance status must be >= 50 for patients =< 16 years of age
Patients must not have received prior radiation therapy to any part of the thorax
Adequate cardiac function defined as:
Shortening fraction of >= 27% by echocardiogram, or
Ejection fraction of >= 50% by radionuclide angiogram
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Walterhouse | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | 30322 | United States | ||
| Ann & Rober H Lurie Children's Hospital of Chicago |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (IMRT) | Patients undergo cardiac-sparing whole lung IMRT. intensity-modulated radiation therapy: Undergo cardiac-sparing whole lung IMRT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| This outcome is measured from central review of radiation plans within 1-2 days of receipt. |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202-5225 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (IMRT) | Patients undergo cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT). intensity-modulated radiation therapy: Undergo cardiac-sparing whole lung IMRT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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 | Feasibility of Delivering Cardiac-sparing IMRT With Central Quality Control in 20 Subjects | Feasibility is defined as an enrolled patient receiving the IMRT treatment as stipulated in the protocol. Feasibility of delivering whole lung IMRT will be demonstrated by obtaining central (Quality Assurance Review Center 'QARC') quality control approval of enrolled patient treatment plans according to the protocol guidelines for the 20 subjects enrolled onto the study. If an enrolled patient did not receive the IMRT treatment as stipulated in the protocol this subject then the treatment will be considered not feasible in this patient. | 14 patients had pediatric sarcomas; 5 had Wilms tumor; 1 had hepatoblastoma. 15/20 received RT to primary site. 15 had CS-IMRT as part of primary therapy vs 5 had CS-IMRT at relapse/progressive disease. At time of CS-IMRT, 18/20 patients' lung tumors were in remission/stable & 2 had progressive disease. | Posted | Count of Participants | Participants | All IMRT treatment plans were centrally reviewed within 1-2 days of receipt of the radiation therapy plan. The feasibility was determined as 'feasible' if deemed in accordance with protocol guidelines after central QARC review within 1-2 days of receipt. |
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| Primary | Short-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease) | Serial CT scans of the chest were examined to determine lung-metastasis free survival | Overall survival and incidence rates of additional relevant clinical data | Posted | Count of Participants | Participants | From date of enrollment until the date of first documented progression, relapse or date of death from any cause up to an average of 3 years. |
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| Secondary | Mean Percentage Radiation Dose to Organ Volumes | The IMRT and standard anteroposterior (AP-PA) treatment plans were reviewed and compared for target coverage and organ dose-volume histograms. The mean percentage volume of the organ or organ sub-region receiving a percentage of the dose was estimated from the computerized treatment plans for these two techniques were estimated and compared statistically | Posted | Mean | Standard Deviation | Mean % radiation dose to % organ volume | This outcome is measured from central review of radiation plans within 1-2 days of receipt. |
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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 (IMRT) | Patients undergo cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT). | 2 | 20 | 2 | 20 | 0 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deceased from progressive disease. | General disorders | Multi-organ failure from progressive and terminal cancer. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Walterhouse | Ann & Robert H. Lurie Children's Hospital of Chicago | 3122274000 | d-walterhouse@northwestern.edu |
| ID | Term |
|---|---|
| D012208 | Rhabdomyosarcoma |
| D012512 | Sarcoma, Ewing |
| D012509 | Sarcoma |
| D009396 | Wilms Tumor |
| ID | Term |
|---|---|
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018193 | Neoplasms, Complex and Mixed |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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