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

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

management of therapy complications

quality-of-life assessment

About this trial

This is an interventional supportive care trial for Long-term Effects Secondary to Cancer Therapy in Children focused on measuring long-term effects secondary to cancer therapy in children, previously treated childhood rhabdomyosarcoma

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003801

First Posted

November 1, 1999

Last Updated

August 19, 2009

Sponsor

National Cancer Institute (NCI)

Collaborators

Pediatric Oncology Group, Children's Cancer Group

1. Study Identification

Unique Protocol Identification Number

NCT00003801

Brief Title

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

Official Title

Intergroup Rhabdomyosarcoma Study Group: Late Effects After Treatment for Rhabdomyosarcoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2000

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Institute (NCI)

Collaborators

Pediatric Oncology Group, Children's Cancer Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

management of therapy complications

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William M. Crist, MD

Organizational Affiliation

University of Missouri-Columbia

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Michael P. Link, MD

Organizational Affiliation

Stanford University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

R. Beverly Raney, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Study Chair

12. IPD Sharing Statement

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

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