Skip to content

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

Intergroup Rhabdomyosarcoma Study Group: Late Effects After Treatment for Rhabdomyosarcoma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00003801
Enrollment
Unknown
Registered
2004-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2009-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long-term Effects Secondary to Cancer Therapy in Children, Sarcoma

Keywords

long-term effects secondary to cancer therapy in children, previously treated childhood rhabdomyosarcoma

Brief 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.

Interventions

PROCEDUREmanagement of therapy complications
PROCEDUREquality-of-life assessment

Sponsors

Pediatric Oncology Group
CollaboratorOTHER
Children's Cancer Group
CollaboratorOTHER
National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Primary purpose
SUPPORTIVE_CARE

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026