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Health-Related Outcomes in Patients Who Were Previously Treated for Rhabdomyosarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003801
First Posted: May 20, 2004
Last Update Posted: August 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Pediatric Oncology Group
Children's Cancer Group
Information provided by:
National Cancer Institute (NCI)
November 1, 1999
May 20, 2004
August 20, 2009
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Complete list of historical versions of study NCT00003801 on ClinicalTrials.gov Archive Site
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Health-Related Outcomes in Patients Who Were Previously Treated for Rhabdomyosarcoma
Intergroup Rhabdomyosarcoma Study Group: Late Effects After Treatment for Rhabdomyosarcoma

RATIONALE: Cancer treatment may have risks that affect health outcomes later. It is not yet known what health outcomes may be related to previous treatment for rhabdomyosarcoma.

PURPOSE: Study to determine health outcomes in patients who have survived 5 years after receiving treatment for rhabdomyosarcoma on the Intergroup Rhabdomyosarcoma Study Group protocols.

OBJECTIVES: I. Determine the frequency of self reported health related outcomes in patients with rhabdomyosarcoma who survived 5 years from diagnosis after treatment on Intergroup Rhabdomyosarcoma Study Group (IRSG) protocols I, II, III, and IV pilot. II. Determine the mortality of these patients and compare this mortality to the general population, especially in the third and fourth decades of life. III. Determine treatment specific risks of developing a second malignancy following treatment of rhabdomyosarcoma and the potential genetic influences (family history of cancer). IV. Determine the association between decreased fertility/offspring and dose, schedule, and total dose of alkylating agents (especially cyclophosphamide) received during treatment and with selected genitourinary and paratesticular primaries. V. Determine the effect of the dose and location of therapeutic radiation for primary head and neck cancer on achieved final height. VI. Determine the association of therapy with doxorubicin (dose and age when received) with cardiac and vascular events.

OUTLINE: Patients (or parent or surviving family member) complete the baseline questionnaire plus other questionnaires (offspring, family history, other topic specific). Medical data is also collected from past records.

PROJECTED ACCRUAL: Approximately 1600 patients will be accrued for this study.

Interventional
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Primary Purpose: Supportive Care
  • Long-term Effects Secondary to Cancer Therapy in Children
  • Sarcoma
  • Procedure: management of therapy complications
  • Procedure: quality-of-life assessment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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DISEASE CHARACTERISTICS: Prior registration on Intergroup Rhabdomyosarcoma Study Group Study IRS-I, IRS-II, IRS-III, IRS-IV pilot, IRS-V, or IRS-V pilot, or one of the protocols of IRS-V (D9501, D9502, D9602) AND Survived for 5 years after diagnosis (may be deceased now)

PATIENT CHARACTERISTICS: Age: 5 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Sexes Eligible for Study: All
5 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00003801
CDR0000066945
IRS-D9801
CCG-D9801
POG-D9801
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National Cancer Institute (NCI)
  • Pediatric Oncology Group
  • Children's Cancer Group
Study Chair: William M. Crist, MD University of Missouri-Columbia
Study Chair: Michael P. Link, MD Stanford University
Study Chair: R. Beverly Raney, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
February 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP