Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases
This study is currently recruiting participants.
Verified April 2012 by Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators:
Northwestern University
Information provided by (Responsible Party):
David O Walterhouse, MD, Children's Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01586104
First received: April 23, 2012
Last updated: April 26, 2012
Last verified: April 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Adult Rhabdomyosarcoma Lung Metastases Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Previously Treated Childhood Rhabdomyosarcoma Recurrent Adult Soft Tissue Sarcoma Recurrent Childhood Rhabdomyosarcoma Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Recurrent Wilms Tumor and Other Childhood Kidney Tumors Stage IV Adult Soft Tissue Sarcoma Stage IV Wilms Tumor Stage V Wilms Tumor Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific |
Radiation: intensity-modulated radiation therapy |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Cardiac-Sparing Whole Lung IMRT in Children and Young Adults With Lung Metastases: A Feasibility Study |
Resource links provided by NLM:
Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Primary Outcome Measures:
- Feasibility of delivering cardiac-sparing IMRT with central quality control in 20 subjects [ Time Frame: 1-5 years ] [ Designated as safety issue: No ]Feasibility of delivering whole lung IMRT will be demonstrated by obtaining QARC central quality control approval of institutional IMRT plans for the 20 subjects enrolled onto the study.
- Dosimetric advantages of whole lung IMRT treatment over standard whole lung irradiation [ Time Frame: 1-5 years ] [ Designated as safety issue: No ]Compare treatment plans and different organ dose-volume histograms such as lungs, heart, thyroid gland, liver etc.
- Short-term efficacy (lung-metastases free survival) and acute tolerance of whole lung IMRT [ Time Frame: Estimated using Kaplan-Meier survival curves (six months after IMRT) ] [ Designated as safety issue: No ]At a minimum period of six months after IMRT
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2011 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (IMRT)
Patients undergo cardiac-sparing whole lung IMRT.
|
Radiation: intensity-modulated radiation therapy
Undergo cardiac-sparing whole lung IMRT
Other Name: IMRT
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 1 Year to 29 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 =< 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586104
Contacts
| Contact: David Walterhouse, MD | 773.880.4562 | d-walterhouse@northwestern.edu |
| Contact: John Kalapurakal, MD | 312-695-1301 | cancer@northwestern.edu |
Locations
| United States, Illinois | |
| Children's Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact: David Walterhouse, MD 773-880-4562 | |
| Principal Investigator: David Walterhouse, MD | |
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Northwestern University
More Information
No publications provided
| Responsible Party: | David O Walterhouse, MD, Attending Physician, Children's Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01586104 History of Changes |
| Other Study ID Numbers: | Lung IMRT |
| Study First Received: | April 23, 2012 |
| Last Updated: | April 26, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Additional relevant MeSH terms:
|
Kidney Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Wilms Tumor Rhabdomyosarcoma Lung Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Rhabdomyosarcoma, Embryonal Sarcoma Neoplasms Sarcoma, Ewing's Neuroectodermal Tumors, Primitive, Peripheral Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Kidney Diseases Urologic Diseases Neoplastic Processes Pathologic Processes Neoplasms, Complex and Mixed Neoplasms by Histologic Type Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases |
ClinicalTrials.gov processed this record on May 19, 2013