Clinical trial · Interventional
Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases
Cardiac-Sparing Whole Lung IMRT in Children and Young Adults With Lung Metastases: A Feasibility Study
NCT01586104CI-TRIAL-00085718completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Rhabdomyosarcoma | Adult Rhabdomyosarcoma | ONTOLOGY_EXACT | 0.98 |
| Lung Metastases | — | UNRESOLVED | — |
| Metastatic Ewing Sarcoma | Ewing Sarcoma | CURATED_BROADER | 0.78 |
| Previously Treated Childhood Rhabdomyosarcoma | Childhood Rhabdomyosarcoma | CURATED_BROADER | 0.78 |
| Recurrent Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Recurrent Childhood Rhabdomyosarcoma | Childhood Rhabdomyosarcoma | CURATED_BROADER | 0.78 |
| Recurrent Wilms Tumor and Other Childhood Kidney Tumors | — | UNRESOLVED | — |
| Stage IV Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage IV Wilms Tumor | Wilms Tumor |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (IMRT)
- description
- Patients undergo cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT).
- interventionNames
- Radiation: intensity-modulated radiation therapy
Primary outcomes (2)
- measure
- Feasibility of Delivering Cardiac-sparing IMRT With Central Quality Control in 20 Subjects
- timeFrame
- 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.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 29 Years
Show eligibility criteria text
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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.