Health-Related Outcomes in Patients Who Were Previously Treated for Rhabdomyosarcoma
|ClinicalTrials.gov Identifier: NCT00003801|
Recruitment Status : Completed
First Posted : May 20, 2004
Last Update Posted : August 20, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Long-term Effects Secondary to Cancer Therapy in Children Sarcoma||Procedure: management of therapy complications Procedure: quality-of-life assessment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Primary Purpose:||Supportive Care|
|Official Title:||Intergroup Rhabdomyosarcoma Study Group: Late Effects After Treatment for Rhabdomyosarcoma|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003801
|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|