- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00003801
Health-Related Outcomes in Patients Who Were Previously Treated for Rhabdomyosarcoma
Intergroup Rhabdomyosarcoma Study Group: Late Effects After Treatment for Rhabdomyosarcoma
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: William M. Crist, MD, University of Missouri-Columbia
- Studiestol: Michael P. Link, MD, Stanford University
Studierekorddatoer
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CDR0000066945
- IRS-D9801
- CCG-D9801
- POG-D9801
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .