Spots Global Cancer Trial Database for Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma
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Trial Identification
Brief Title: Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma
Official Title: A Study of Unilateral Retinoblastoma With and Without Histopathologic High-Risk Features and the Role of Adjuvant Chemotherapy
Study ID: NCT00335738
Conditions
Study Description
Brief Summary: This phase III trial is studying vincristine, carboplatin, and etoposide to see how well they work compared to observation only in treating patients who have undergone surgery for newly diagnosed retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, no additional treatment is needed for the tumor until it progresses. In this case, observation may be sufficient.
Detailed Description: OBJECTIVES: I. Prospectively determine the prevalence of high-risk histopathologic features, such as choroidal involvement, optic nerve invasion, and scleral and anterior segment involvement, in patients with newly diagnosed unilateral retinoblastoma who have undergone enucleation. II. Demonstrate that patients without certain high-risk features can be successfully treated with enucleation alone by estimating the event-free survival (EFS) (where an event is defined as the occurrence of extraocular or metastatic disease) and overall survival (OS). III. Estimate the EFS and OS of patients with specific high-risk features who are uniformly treated with adjuvant chemotherapy comprising vincristine, carboplatin, and etoposide. IV. Estimate the incidence of toxicities associated with the proposed adjuvant chemotherapy regimen. OUTLINE: This is a prospective, nonrandomized, multicenter study. Patients are assigned to 1 of 2 groups according to presence of high-risk histopathologic features. GROUP 1 (high-risk features): Patients receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. GROUP 2 (no high-risk features): Patients undergo observation periodically for at least 5 years. GROUP 3 (no consensus regarding high risk features can be reached): Patients undergo Group 1 chemotherapy or observation according to institutional high-risk feature assessment. After completion of study treatment, patients in group 1 are followed periodically for at least 5 years.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of Arizona Health Sciences Center, Tucson, Arizona, United States
Children's Oncology Group, Arcadia, California, United States
Southern California Permanente Medical Group, Downey, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Rady Children's Hospital - San Diego, San Diego, California, United States
University of California San Francisco Medical Center-Parnassus, San Francisco, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Children's National Medical Center, Washington, District of Columbia, United States
Lombardi Comprehensive Cancer Center at Georgetown University, Washington, District of Columbia, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
University of Illinois, Chicago, Illinois, United States
Childrens Memorial Hospital, Chicago, Illinois, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Kentucky, Lexington, Kentucky, United States
Kosair Children's Hospital, Louisville, Kentucky, United States
Maine Children's Cancer Program, Scarborough, Maine, United States
Johns Hopkins University, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Wayne State University, Detroit, Michigan, United States
University of Minnesota Medical Center-Fairview, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
The Childrens Mercy Hospital, Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Brooklyn Hospital Center, Brooklyn, New York, United States
Carolinas Medical Center, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Rainbow Babies and Childrens Hospital, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
The Children's Medical Center of Dayton, Dayton, Ohio, United States
Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Cook Children's Medical Center, Fort Worth, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
Covenant Children's Hospital, Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Scott and White Memorial Hospital, Temple, Texas, United States
Primary Children's Medical Center, Salt Lake City, Utah, United States
Childrens Hospital-King's Daughters, Norfolk, Virginia, United States
Marshfield Clinic, Marshfield, Wisconsin, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Royal Children's Hospital, Parkville, Victoria, Australia
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Hospital Sainte-Justine, Montreal, Quebec, Canada
L V Prasad Eye Institute, Hyderabad, , India
Starship Children's Hospital, Grafton, Auckland, New Zealand
Christchurch Hospital, Christchurch, , New Zealand
Contact Details
Name: Murali Chintagumpala, MD
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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