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Clinical Trial Name - Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergon
| Original Study ID : CDR0000483043 |
| Secondary ID : COG-ARET0332 |
| NCT ID : NCT00335738 |
| 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 |
| Brief Summary : RATIONALE: 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. PURPOSE: 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. |
| Source : National Cancer Institute (NCI) |
| Detailed Description : OBJECTIVES: - 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. - 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) . - Estimate the EFS and OS of patients with certain high-risk features who are uniformly treated with adjuvant chemotherapy comprising vincristine, carboplatin, and etoposide. - 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. After completion of study treatment, patients in group 1 are followed periodically for at least 5 years. PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study. |
| Overall Status : Recruiting |
| Start Date : December 2005 |
| Official Title : Phase 3 |
| Phase : Interventional |
| Study Design : Treatment, Non-Randomized |
| Enrollment : 600 |
| Verification Date : May 2009 |
| First Received Date : June 8, 2006 |
| Trial Eligibility |
| Criteria : DISEASE CHARACTERISTICS: - Newly diagnosed unilateral retinoblastoma - Underwent enucleation as primary therapy within the past 5 weeks - Must enroll and submit pathology slides within 21 days of enucleation - Adjuvant chemotherapy must begin within 35 days after enucleation - Disease with or without high-risk histopathologic features - High-risk features are defined as any of the following: - Posterior uveal invasion (includes choroidal invasion) - Any degree of concomitant choroid and/or optic nerve involvement - Tumor involving the optic nerve posterior to the lamina cribrosa as an independent finding - Scleral invasion - Anterior chamber seeding - Ciliary body infiltration - Iris infiltration - No evidence of extraocular retinoblastoma clinically, by CT scan, or by MRI of the brain and orbits with and without gadolinium - No tumor at the cut end of the optic nerve on any eye enucleated as evidenced by histologic examination prior to study entry - No systemic metastases as evidenced by bone marrow scan, bone scan, or any other additional test at study entry PATIENT CHARACTERISTICS: - Lansky performance status 50-100% - Hemoglobin > 8 g/dL - Absolute neutrophil count ≥ 1,000/mm³ - Platelet count ≥ 100,000/mm³ - Creatinine adjusted according to age as follows: - No greater than 0.4 mg/dL (≤ 5 months) - No greater than 0.5 mg/dL (6 months -11 months) - No greater than 0.6 mg/dL (1 year-23 months) - No greater than 0.8 mg/dL (2 years-5 years) - No greater than 1.0 mg/dL (6 years-9 years) - No greater than 1.2 mg/dL (10 years-12 years) - No greater than 1.4 mg/dL (13 years and over [female]) - No greater than 1.5 mg/dL (13 years to 15 years [male]) - No greater than 1.7 mg/dL (16 years and over [male]) OR - Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min - Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age - AST or ALT < 2.5 times ULN for age PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior therapy other than enucleation - No prior chemotherapy |
| Gender : Both |
| Minimum Age : N/A |
| Maximum Age : 6 Years |
| Healthy Volunteers : No |
| Facilities |
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| City : Birmingham |
| State : Alabama |
| Zip Code : 35294 |
| Country : United States |
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| City : Tucson |
| State : Arizona |
| Zip Code : 85724-5024 |
| Country : United States |
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| City : Phoenix |
| State : Arizona |
| Zip Code : 85016-7710 |
| Country : United States |
| Facility Name : Arkansas Cancer Research Center at University of Arkansas for Medical Sciences |
| Status : Recruiting |
| City : Little Rock |
| State : Arkansas |
| Zip Code : 72205 |
| Country : United States |
| Facility Name : Children's Hospital Central California |
| Status : Recruiting |
| City : Madera |
| State : California |
| Zip Code : 93638-8762 |
| Country : United States |
| Facility Name : Childrens Hospital Los Angeles |
| Status : Recruiting |
| City : Los Angeles |
| State : California |
| Zip Code : 90027 |
| Country : United States |
| Facility Name : Jonathan Jaques Children's Cancer Center at Miller Children's Hospital |
| Status : Recruiting |
| City : Long Beach |
| State : California |
| Zip Code : 90801 |
| Country : United States |
| Facility Name : Loma Linda University Cancer Institute at Loma Linda University Medical Center |
| Status : Recruiting |
| City : Loma Linda |
| State : California |
| Zip Code : 92354 |
| Country : United States |
| Facility Name : Rady Children's Hospital - San Diego |
| Status : Recruiting |
| City : San Diego |
| State : California |
| Zip Code : 92123-4282 |
| Country : United States |
| Facility Name : Southern California Permanente Medical Group |
| Status : Recruiting |
| City : Downey |
| State : California |
| Zip Code : 90027 |
| Country : United States |
| Facility Name : UCSF Helen Diller Family Comprehensive Cancer Center |
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| City : San Francisco |
| State : California |
| Zip Code : 94115 |
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| Facility Name : Children's Hospital Center for Cancer and Blood Disorders |
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| City : Aurora |
| State : Colorado |
| Zip Code : 80045 |
| Country : United States |
| Facility Name : Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center |
| Status : Recruiting |
| City : Farmington |
| State : Connecticut |
| Zip Code : 06360-2875 |
| Country : United States |
| Facility Name : Alfred I. duPont Hospital for Children |
| Status : Recruiting |
| City : Wilmington |
| State : Delaware |
| Zip Code : 19803 |
| Country : United States |
| Facility Name : Children's National Medical Center |
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| City : Washington |
| State : District of Columbia |
| Zip Code : 20010-2970 |
| Country : United States |
| Facility Name : Lombardi Comprehensive Cancer Center at Georgetown University Medical Center |
| Status : Recruiting |
| City : Washington |
| State : District of Columbia |
| Zip Code : 20007 |
| Country : United States |
| Facility Name : Walter Reed Army Medical Center |
| Status : Recruiting |
| City : Washington |
| State : District of Columbia |
| Zip Code : 20307-5001 |
| Country : United States |
| Facility Name : All Children's Hospital |
| Status : Recruiting |
| City : St. Petersburg |
| State : Florida |
| Zip Code : 33701 |
| Country : United States |
| Facility Name : Kaplan Cancer Center at St. Mary's Medical Center |
| Status : Recruiting |
| City : West Palm Beach |
| State : Florida |
| Zip Code : 33407 |
| Country : United States |
| Facility Name : Nemours Children's Clinic |
| Status : Recruiting |
| City : Jacksonville |
| State : Florida |
| Zip Code : 32207 |
| Country : United States |
| Facility Name : St. Joseph's Cancer Institute at St. Joseph's Hospital |
| Status : Recruiting |
| City : Tampa |
| State : Florida |
| Zip Code : 33607 |
| Country : United States |
| Facility Name : University of Miami Sylvester Comprehensive Cancer Center - Miami |
| Status : Recruiting |
| City : Miami |
| State : Florida |
| Zip Code : 33136 |
| Country : United States |
| Facility Name : Winship Cancer Institute of Emory University |
| Status : Recruiting |
| City : Atlanta |
| State : Georgia |
| Zip Code : 30322 |
| Country : United States |
| Facility Name : Children's Memorial Hospital - Chicago |
| Status : Recruiting |
| City : Chicago |
| State : Illinois |
| Zip Code : 60614 |
| Country : United States |
| Facility Name : Simmons Cooper Cancer Institute |
| Status : Recruiting |
| City : Springfield |
| State : Illinois |
| Zip Code : 62794-9677 |
| Country : United States |
| Facility Name : University of Chicago Cancer Research Center |
| Status : Recruiting |
| City : Chicago |
| State : Illinois |
| Zip Code : 60637-1470 |
| Country : United States |
| Facility Name : University of Illinois Cancer Center |
| Status : Recruiting |
| City : Chicago |
| State : Illinois |
| Zip Code : 60612-7243 |
| Country : United States |
| Facility Name : Indiana University Melvin and Bren Simon Cancer Center |
| Status : Recruiting |
| City : Indianapolis |
| State : Indiana |
| Zip Code : 46202-5289 |
| Country : United States |
| Facility Name : Holden Comprehensive Cancer Center at University of Iowa |
| Status : Recruiting |
| City : Iowa City |
| State : Iowa |
| Zip Code : 52242-1002 |
| Country : United States |
| Facility Name : Kosair Children's Hospital |
| Status : Recruiting |
| City : Louisville |
| State : Kentucky |
| Zip Code : 40232 |
| Country : United States |
| Facility Name : Lucille P. Markey Cancer Center at University of Kentucky |
| Status : Recruiting |
| City : Lexington |
| State : Kentucky |
| Zip Code : 40536-0093 |
| Country : United States |
| Facility Name : Tulane Cancer Center Office of Clinical Research |
| Status : Recruiting |
| City : Alexandria |
| State : Louisiana |
| Zip Code : 71315-3198 |
| Country : United States |
| Facility Name : Maine Children's Cancer Program at Barbara Bush Children's Hospital |
| Status : Recruiting |
| City : Scarborough |
| State : Maine |
| Zip Code : 04074-9308 |
| Country : United States |
| Facility Name : Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Status : Recruiting |
| City : Baltimore |
| State : Maryland |
| Zip Code : 21231-2410 |
| Country : United States |
| Facility Name : Massachusetts General Hospital |
| Status : Recruiting |
| City : Boston |
| State : Massachusetts |
| Zip Code : 02114 |
| Country : United States |
| Facility Name : Barbara Ann Karmanos Cancer Institute |
| Status : Recruiting |
| City : Detroit |
| State : Michigan |
| Zip Code : 48201-1379 |
| Country : United States |
| Facility Name : Mayo Clinic Cancer Center |
| Status : Recruiting |
| City : Rochester |
| State : Minnesota |
| Zip Code : 55905 |
| Country : United States |
| Facility Name : University of Mississippi Cancer Clinic |
| Status : Recruiting |
| City : Jackson |
| State : Mississippi |
| Zip Code : 39216-4505 |
| Country : United States |
| Facility Name : Children's Mercy Hospital |
| Status : Recruiting |
| City : Kansas City |
| State : Missouri |
| Zip Code : 64108 |
| Country : United States |
| Facility Name : Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
| Status : Recruiting |
| City : St. Louis |
| State : Missouri |
| Zip Code : 63110 |
| Country : United States |
| Facility Name : Children's Hospital |
| Status : Recruiting |
| City : Omaha |
| State : Nebraska |
| Zip Code : 68114-4113 |
| Country : United States |
| Facility Name : CCOP - Nevada Cancer Research Foundation |
| Status : Recruiting |
| City : Las Vegas |
| State : Nevada |
| Zip Code : 89109-2306 |
| Country : United States |
| Facility Name : Hackensack University Medical Center Cancer Center |
| Status : Recruiting |
| City : Hackensack |
| State : New Jersey |
| Zip Code : 07601 |
| Country : United States |
| Facility Name : Overlook Hospital |
| Status : Recruiting |
| City : Morristown |
| State : New Jersey |
| Zip Code : 07962 |
| Country : United States |
| Facility Name : University of New Mexico Cancer Center |
| Status : Recruiting |
| City : Albuquerque |
| State : New Mexico |
| Zip Code : 87131-5636 |
| Country : United States |
| Facility Name : SUNY Upstate Medical University Hospital |
| Status : Recruiting |
| City : Syracuse |
| State : New York |
| Zip Code : 13210 |
| Country : United States |
| Facility Name : Duke Comprehensive Cancer Center |
| Status : Recruiting |
| City : Durham |
| State : North Carolina |
| Zip Code : 27710 |
| Country : United States |
| Facility Name : Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill |
| Status : Recruiting |
| City : Chapel Hill |
| State : North Carolina |
| Zip Code : 27599-7295 |
| Country : United States |
| Facility Name : Presbyterian Cancer Center at Presbyterian Hospital |
| Status : Recruiting |
| City : Charlotte |
| State : North Carolina |
| Zip Code : 28233-3549 |
| Country : United States |
| Facility Name : Children's Medical Center - Dayton |
| Status : Recruiting |
| City : Dayton |
| State : Ohio |
| Zip Code : 45404-1815 |
| Country : United States |
| Facility Name : Cincinnati Children's Hospital Medical Center |
| Status : Recruiting |
| City : Cincinnati |
| State : Ohio |
| Zip Code : 45229-3039 |
| Country : United States |
| Facility Name : Cleveland Clinic Taussig Cancer Center |
| Status : Recruiting |
| City : Cleveland |
| State : Ohio |
| Zip Code : 44195 |
| Country : United States |
| Facility Name : Rainbow Babies and Children's Hospital |
| Status : Recruiting |
| City : Cleveland |
| State : Ohio |
| Zip Code : 44106-5000 |
| Country : United States |
| Facility Name : Oklahoma University Cancer Institute |
| Status : Recruiting |
| City : Oklahoma City |
| State : Oklahoma |
| Zip Code : 73104 |
| Country : United States |
| Facility Name : Children's Hospital of Philadelphia |
| Status : Recruiting |
| City : Philadelphia |
| State : Pennsylvania |
| Zip Code : 19104-9786 |
| Country : United States |
| Facility Name : Children's Hospital of Pittsburgh |
| Status : Recruiting |
| City : Pittsburgh |
| State : Pennsylvania |
| Zip Code : 15213 |
| Country : United States |
| Facility Name : Lehigh Valley Hospital - Muhlenberg |
| Status : Recruiting |
| City : Bethlehem |
| State : Pennsylvania |
| Zip Code : 18017 |
| Country : United States |
| Facility Name : St. Christopher's Hospital for Children |
| Status : Recruiting |
| City : Philadelphia |
| State : Pennsylvania |
| Zip Code : 19134-1095 |
| Country : United States |
| Facility Name : Hollings Cancer Center at Medical University of South Carolina |
| Status : Recruiting |
| City : Charleston |
| State : South Carolina |
| Zip Code : 29425 |
| Country : United States |
| Facility Name : Vanderbilt-Ingram Cancer Center |
| Status : Recruiting |
| City : Nashville |
| State : Tennessee |
| Zip Code : 37232-6838 |
| Country : United States |
| Facility Name : Baylor University Medical Center - Houston |
| Status : Recruiting |
| City : Houston |
| State : Texas |
| Zip Code : 77030-2399 |
| Country : United States |
| Facility Name : CCOP - Scott and White Hospital |
| Status : Recruiting |
| City : Temple |
| State : Texas |
| Zip Code : 76508 |
| Country : United States |
| Facility Name : Cook Children's Medical Center - Fort Worth |
| Status : Recruiting |
| City : Fort Worth |
| State : Texas |
| Zip Code : 76104 |
| Country : United States |
| Facility Name : Dell Children's Medical Center of Central Texas |
| Status : Recruiting |
| City : Austin |
| State : Texas |
| Zip Code : 78723 |
| Country : United States |
| Facility Name : M. D. Anderson Cancer Center at University of Texas |
| Status : Recruiting |
| City : Houston |
| State : Texas |
| Zip Code : 77030-4009 |
| Country : United States |
| Facility Name : Medical City Dallas Hospital |
| Status : Recruiting |
| City : Dallas |
| State : Texas |
| Zip Code : 75230 |
| Country : United States |
| Facility Name : Texas Tech University Health Sciences Center School of Medicine - Amarillo |
| Status : Recruiting |
| City : Amarillo |
| State : Texas |
| Zip Code : 79106 |
| Country : United States |
| Facility Name : University of Texas Health Science Center at San Antonio |
| Status : Recruiting |
| City : San Antonio |
| State : Texas |
| Zip Code : 78207 |
| Country : United States |
| Facility Name : Primary Children's Medical Center |
| Status : Recruiting |
| City : Salt Lake City |
| State : Utah |
| Zip Code : 84113-1100 |
| Country : United States |
| Facility Name : Children's Hospital of The King's Daughters |
| Status : Recruiting |
| City : Norfolk |
| State : Virginia |
| Zip Code : 23507-1971 |
| Country : United States |
| Facility Name : Children's Hospital and Regional Medical Center - Seattle |
| Status : Recruiting |
| City : Seattle |
| State : Washington |
| Zip Code : 98105 |
| Country : United States |
| Facility Name : West Virginia University Health Sciences Center - Charleston |
| Status : Recruiting |
| City : Charleston |
| State : West Virginia |
| Zip Code : 25302 |
| Country : United States |
| Facility Name : Marshfield Clinic - Marshfield Center |
| Status : Recruiting |
| City : Marshfield |
| State : Wisconsin |
| Zip Code : 54449 |
| Country : United States |
| Facility Name : Midwest Children's Cancer Center at Children's Hospital of Wisconsin |
| Status : Recruiting |
| City : Milwaukee |
| State : Wisconsin |
| Zip Code : 53226 |
| Country : United States |
| Facility Name : Westmead Institute for Cancer Research at Westmead Hospital |
| Status : Recruiting |
| City : Westmead |
| State : New South Wales |
| Zip Code : 2145 |
| Country : Australia |
| Facility Name : Royal Children's Hospital |
| Status : Recruiting |
| City : Brisbane |
| State : Queensland |
| Zip Code : 4029 |
| Country : Australia |
| Facility Name : Royal Children's Hospital |
| Status : Recruiting |
| City : Parkville |
| State : Victoria |
| Zip Code : 3052 |
| Country : Australia |
| Facility Name : Princess Margaret Hospital for Children |
| Status : Recruiting |
| City : Perth |
| State : Western Australia |
| Zip Code : 6001 |
| Country : Australia |
| Facility Name : Children's & Women's Hospital of British Columbia |
| Status : Recruiting |
| City : Vancouver |
| State : British Columbia |
| Zip Code : V6H 3V4 |
| Country : Canada |
| Facility Name : CancerCare Manitoba |
| Status : Recruiting |
| City : Winnipeg |
| State : Manitoba |
| Zip Code : R3E 0V9 |
| Country : Canada |
| Facility Name : IWK Health Centre |
| Status : Recruiting |
| City : Halifax |
| State : Nova Scotia |
| Zip Code : B3K 6R8 |
| Country : Canada |
| Facility Name : Hopital Sainte Justine |
| Status : Recruiting |
| City : Montreal |
| State : Quebec |
| Zip Code : H3T 1C5 |
| Country : Canada |
| Facility Name : Montreal Children's Hospital at McGill University Health Center |
| Status : Recruiting |
| City : Montreal |
| State : Quebec |
| Zip Code : H3H 1P3 |
| Country : Canada |
| Facility Name : Christchurch Hospital |
| Status : Recruiting |
| City : Christchurch |
| State : Quebec |
| Zip Code : 8140 |
| Country : New Zealand |
| Facility Name : Starship Children's Health |
| Status : Recruiting |
| City : Auckland |
| State : Quebec |
| Zip Code : 1 |
| Country : New Zealand |
| OutComes |
| Primary OutComes |
| Secondary OutComes |
| Measure : Toxicity |
| Safety issue : Yes |
| Interventions |
| Type : Drug |
| Name : carboplatin |
| Description : Given IV |
| Type : Drug |
| Name : etoposide |
| Description : Given IV |
| Type : Drug |
| Name : vincristine sulfate |
| Description : Given IV |
| Type : Procedure |
| Name : observation |
| Description : Patients undergo observation periodically for at least 5 years. |
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