Adult RhabdomyosarcomaNCT01586104
Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases
A study testing intensity-modulated radiation therapy in people with Adult Rhabdomyosarcoma and Lung Metastases, run by Ann & Robert H Lurie Children's Hospital of Chicago at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 29 years
- Conditions the study is for
- Adult Rhabdomyosarcoma, Lung Metastases, Metastatic Ewing Sarcoma
- What is being tested?
- intensity-modulated radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2011to 2 Jun 2016
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Ann & Rober H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
M D Anderson Cancer Center
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46202-5225
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Cardiac-Sparing Whole Lung IMRT in Children and Young Adults With Lung Metastases: A Feasibility Study
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.
Read the detailed description
OBJECTIVES:
- 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.
- Conditions
- Adult Rhabdomyosarcoma, Lung Metastases, Metastatic Ewing Sarcoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Childhood Rhabdomyosarcoma
- Being tested
- intensity-modulated radiation therapy
- Medical subject headings
- Rhabdomyosarcoma, Sarcoma, Ewing, Sarcoma, Wilms Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensity-modulated radiation therapyRadiation
Also called IMRT
Undergo cardiac-sparing whole lung IMRT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (IMRT) | Experimental | Patients undergo cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT). Receives: Radiation: intensity-modulated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Secondary outcomes (1)
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
Measured: This outcome is measured from central review of radiation plans within 1-2 days of receipt.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startFeb 2011
- Primary completion2 Jun 2016
- Study completion2 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult RhabdomyosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, John Kalapurakal, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- David Walterhouse, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586104
- Sponsor's protocol ID
- Lung IMRT
- Other IDs
- R21CA159547
- Status last verified
- Feb 2025
- First submitted
- 23 Apr 2012
- Last updated
- 10 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes