Clinical Trials Directory

Trials / Completed

CompletedNCT00003801

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

Intergroup Rhabdomyosarcoma Study Group: Late Effects After Treatment for Rhabdomyosarcoma

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
5 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREmanagement of therapy complications
PROCEDUREquality-of-life assessment

Timeline

First posted
2004-05-20
Last updated
2009-08-20

Source: ClinicalTrials.gov record NCT00003801. Inclusion in this directory is not an endorsement.