N/A
N=20
Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases
Adult Rhabdomyosarcoma · Lung Metastases · Metastatic Ewing Sarcoma · Previously Treated Childhood Rhabdomyosarcoma · Recurrent Adult Soft Tissue Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT01586104 ↗Enrolled (actual)
20
Serious AEs
10.0%
Results posted
Feb 2025
Primary outcome: Primary: Feasibility of Delivering Cardiac-sparing IMRT With Central Quality Control in 20 Subjects — 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- intensity-modulated radiation therapy (Radiation)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Delivering Cardiac-sparing IMRT With Central Quality Control in 20 Subjects |
20 | — |
| PRIMARY Short-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease) |
18; 18; 13; 10; 8; 4 | — |
| SECONDARY Mean Percentage Radiation Dose to Organ Volumes |
96; 100; 65; 100; 39; 97 | <0.0125 sig |
Summary
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.
Eligibility Criteria
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 = = 27% by echocardiogram, or
- Ejection fraction of >= 50% by radionuclide angiogram
- Female patients of childbearing age must have a negative pregnancy test
- Female patients who are lactating must agree to stop breast-feeding
- Sexually active patients of childbearing potential must agree to use effective contraception
Exclusion Criteria
- Patients enrolled on Children's Oncology Group protocols cannot be treated with whole lung IMRT on this study
- Patients who have a prior history of radiation therapy to the thorax or adjacent regions cannot be entered on this protocol
- Patient with Hodgkin's Lymphoma are not eligible for this study
- Patients with mediastinal masses or other pulmonary masses requiring additional mediastinal or lung irradiation beyond the whole lung irradiation (WLI) doses stated in this protocol are ineligible for this study
- Patients who may require concurrent or sequential irradiation to sites beyond the chest such as the neck, flank, abdomen or liver are eligible for this study
Data sourced from ClinicalTrials.gov (NCT01586104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.