Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases

NCT01586104 | Completed Results DMC

• 2 other identifiers: Lung IMRTR21CA159547
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Adult Rhabdomyosarcoma; Lung Metastases; Metastatic Ewing Sarcoma; Previously Treated Childhood Rhabdomyosarcoma; Recurrent Adult Soft Tissue Sarcoma; Recurrent Childhood Rhabdomyosarcoma; 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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

  This outcome is measured from central review of radiation plans within 1-2 days of receipt.

Study Arms (1)

Treatment (IMRT)

EXPERIMENTAL

Patients undergo cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT).

Radiation: intensity-modulated radiation therapy

Interventions

intensity-modulated radiation therapy RADIATION

Undergo cardiac-sparing whole lung IMRT

Also known as: IMRT

Treatment (IMRT)

Eligibility Criteria

• Age: 1 Year - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Northwestern University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, 30322, United States

Location

Ann & Rober H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202-5225, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Rhabdomyosarcoma; Sarcoma, Ewing; Sarcoma; Wilms Tumor

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Dr. David Walterhouse
• Organization: Ann & Robert H. Lurie Children's Hospital of Chicago

d-walterhouse@northwestern.edu

3122274000

Study Officials

• David Walterhouse

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 26, 2012
• Study Start: February 1, 2011
• Primary Completion: June 2, 2016
• Study Completion: June 2, 2016
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-02

Locations

US (7)