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

Sarcoma Clinical Trial

Official title:

Intergroup Rhabdomyosarcoma Study Group: Late Effects After Treatment for Rhabdomyosarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003801
• Other study ID #: CDR0000066945
• Secondary ID: IRS-D9801CCG-D98
• Status: Completed
• Phase: N/A
• First received: November 1, 1999
• Last updated: August 19, 2009

Study information

• Verified date: February 2000
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Long-term Effects Secondary to Cancer Therapy in Children
• Rhabdomyosarcoma
• Sarcoma

Intervention

Procedure:
• management of therapy complications

• quality-of-life assessment

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)	Children's Cancer Group, Pediatric Oncology Group