Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma
- Conditions
- Sarcoma
- Interventions
- Biological: dactinomycinProcedure: Conventional SurgeryBiological: MESNA (mercaptoethane sulfonate)Biological: Filgrastim
- Registration Number
- NCT00072280
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. Giving combination chemotherapy after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well surgery and/or combination chemotherapy work in treating children with fibrosarcoma.
- Detailed Description
OBJECTIVES:
Primary
* Determine the event-free and relapse-free survival of children with initially unresectable congenital, infantile, or childhood fibrosarcoma treated with neoadjuvant chemotherapy comprising vincristine, dactinomycin, and cyclophosphamide (VAC) before definitive local control.
Secondary
* Determine the event-free and relapse-free survival of patients initially treated with this regimen followed by observation after local control with positive microscopic margins.
* Determine the event-free and relapse-free survival of patients initially treated with this regimen followed by additional chemotherapy comprising etoposide and ifosfamide after local control with gross positive margins.
* Determine the event-free and relapse-free survival of patients treated with surgery alone.
OUTLINE: This is a pilot, multicenter study. Patients begin treatment according to lesion resectability.
Patients with resectable lesions proceed to surgery.
* Surgery: Patients undergo resection of disease lesions. Patients with clear or microscopically positive margins undergo observation only. Patients with grossly positive margins undergo re-resection if feasible. Patients with grossly positive margins after re-resection or for whom re-resection is not feasible receive chemotherapy comprising vincristine, dactinomycin, and cyclophosphamide (VAC).
Patients with unresectable lesions receive VAC chemotherapy.
* VAC chemotherapy: Patients receive vincristine intravenously (IV) on days 1, 8, and 15 and dactinomycin IV and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with disease progression after 2-4 courses of VAC chemotherapy proceed to chemotherapy comprising etoposide and ifosfamide (IE).
Patients with stable disease after 4 courses of VAC chemotherapy proceed to IE chemotherapy.
Patients with a partial response (PR) and unresectable lesions after 4 courses of VAC chemotherapy receive 2 additional courses of VAC and are then re-evaluated. Patients proceed to surgery if they continue to have a PR or achieve a complete response (CR) and lesions are now resectable.
Patients with a CR or PR and resectable lesions after 4 courses of VAC chemotherapy proceed to surgery.
Patients with stable disease, progressive disease, or a PR and unresectable lesions after 6 courses of VAC proceed to IE chemotherapy.
* IE chemotherapy: Patients receive etoposide IV over 1 hour and ifosfamide IV over 1 hour on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with a CR or PR and resectable lesions after 2-4 courses of IE chemotherapy proceed to surgery.
All patients are followed every 3 months for 6 months, every 6 months for 1 year, and then as clinically indicated.
PROJECTED ACCRUAL: A total of 60-70 patients will be accrued for this study within 8 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemotherapy plus possible surgery vincristine sulfate Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery. (See Interventions section for drug dosage and administration details.) Chemotherapy plus possible surgery dactinomycin Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery. (See Interventions section for drug dosage and administration details.) Chemotherapy plus possible surgery MESNA (mercaptoethane sulfonate) Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery. (See Interventions section for drug dosage and administration details.) Chemotherapy plus possible surgery Conventional Surgery Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery. (See Interventions section for drug dosage and administration details.) Chemotherapy plus possible surgery Filgrastim Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery. (See Interventions section for drug dosage and administration details.) Surgery only Conventional Surgery Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention. Chemotherapy plus possible surgery ifosfamide Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery. (See Interventions section for drug dosage and administration details.) Chemotherapy plus possible surgery etoposide Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery. (See Interventions section for drug dosage and administration details.) Chemotherapy plus possible surgery cyclophosphamide Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery. (See Interventions section for drug dosage and administration details.)
- Primary Outcome Measures
Name Time Method Failure-free Survival (FFS) in "Chemotherapy Plus Possible Surgery" Arm Study enrollment until failure, completion of follow-up, or completion of 5-year FFS analyses (up to 5 years) Failure is defined as the occurrence of one of the following: disease progression, defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions; relapse (defined with same criteria as for disease progression) after response; or death as a first event. Data will be summarized as number of eligible patients in each of the following categories at the time of data cutoff for analyses of 5-year FFS: 1)Failed; 2)Failure-free through 5 years of follow-up; 3)Failure-free until data cutoff (if less than 5 years of follow-up); 4)Withdrew from study; 5)Lost to follow-up. NOTE: Reported data are through March 2008 (see Caveats section).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (74)
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Spectrum Health Hospital - Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Hackensack University Medical Center Cancer Center
🇺🇸Hackensack, New Jersey, United States
Overlook Hospital
🇺🇸Morristown, New Jersey, United States
Children's Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Columbus Children's Hospital
🇺🇸Columbus, Ohio, United States
Tod Children's Hospital - Forum Health
🇺🇸Youngstown, Ohio, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Rhode Island Hospital Comprehensive Cancer Center
🇺🇸Providence, Rhode Island, United States
East Tennessee Children's Hospital
🇺🇸Knoxville, Tennessee, United States
Greenville Hospital System Cancer Center
🇺🇸Greenville, South Carolina, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Westmead Institute for Cancer Research at Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Women's and Children's Hospital
🇦🇺North Adelaide, South Australia, Australia
Children's & Women's Hospital of British Columbia
🇨🇦Vancouver, British Columbia, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Montreal Children's Hospital at McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Starship Children's Health
🇳🇿Auckland, New Zealand
Saskatoon Cancer Centre at the University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
🇺🇸Long Beach, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸Sacramento, California, United States
Stanford Comprehensive Cancer Center - Stanford
🇺🇸Stanford, California, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
MBCCOP - Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Covenant Children's Hospital
🇺🇸Lubbock, Texas, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Providence Cancer Center at Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
University of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Children's Hospitals and Clinics of Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Methodist Children's Hospital of South Texas
🇺🇸San Antonio, Texas, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital
🇺🇸Indianapolis, Indiana, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Baylor University Medical Center - Houston
🇺🇸Houston, Texas, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
University of Minnesota Medical Center & Children's Hospital - Fairview
🇺🇸Minneapolis, Minnesota, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
OU Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Lee Cancer Care of Lee Memorial Health System
🇺🇸Fort Myers, Florida, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
CancerCare of Maine at Eastern Maine Medial Center
🇺🇸Bangor, Maine, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States