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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Show all 9Show fewer

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.

City, postcode or hospital

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

Other trials in United States

About this study

Official title: Cardiac-Sparing Whole Lung IMRT in Children and Young Adults With Lung Metastases: A Feasibility Study

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 groups in NCT01586104
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.

Feb 20112 Jun 2016

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cardiac-Sparing Whole Lung IMRT in Children and Young Adults With Lung Metastases: A Feasibility Study
ClinicalTrials.gov ID: NCT01586104
Acronym / sponsor ID: Lung IMRT
Conditions: Adult Rhabdomyosarcoma, Lung Metastases, Metastatic Ewing Sarcoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Childhood Rhabdomyosarcoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
Collaborators: Northwestern University, National Cancer Institute (NCI)
Study start: Feb 2011 (actual)
Primary completion: 2 Jun 2016 (actual)
Study completion: 2 Jun 2016 (actual)
First posted: 26 Apr 2012 (estimated)
Results: Posted 10 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (IMRT)	Experimental	Radiation: intensity-modulated radiation therapyPatients undergo cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT).

Who may qualify

Ages: 1 year to 29 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
intensity-modulated radiation therapyAlso: IMRTUndergo cardiac-sparing whole lung IMRT	Radiation	Treatment (IMRT)

Primary outcome

Feasibility of Delivering Cardiac-sparing IMRT With Central Quality Control in 20 Subjects
Time frame: 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.
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.
Short-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease)
Time frame: 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.
Serial CT scans of the chest were examined to determine lung-metastasis free survival

1 secondary outcome

Mean Percentage Radiation Dose to Organ Volumes
Time frame: This outcome is measured from central review of radiation plans within 1-2 days of receipt.

Results and safety

Results posted to the registry on 10 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (IMRT)	20	20

Primary outcome: Feasibility of Delivering Cardiac-sparing IMRT With Central Quality Control in 20 Subjects

Time frame: 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.. Count of participants. Unit: Participants

Measure	Treatment (IMRT) n = 20
Value	20

Population analysed: 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.

Primary outcome: Short-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease)

Time frame: 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.. Count of participants. Unit: Participants

Measure	Treatment (IMRT) n = 20
2yr overall survival	18
3yr overall survival	18
2yr lung-metastasis progression free survival	13
3yr lung-metastasis progression free survival	10
Pulmonary relapse	8
Pulmonary relapse - after primary therapy	4
Pulmonary relapse - after relapse/progression	4
Deceased from progressive disease	2

Population analysed: Overall survival and incidence rates of additional relevant clinical data

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (IMRT)	2 of 20 (10%)	0 of 20 (0%)	2 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Walterhouse principal investigator

Ann & Robert H Lurie Children's Hospital of Chicago

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Delivering Cardiac-sparing IMRT With Central Quality Control in 20 Subjects (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01586104.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.