Adrenokortikal Tümörü Olan Genç Hastaların Tedavisinde Sisplatin Temelli Kemoterapi ve/veya Cerrahi

Sade dilde özet

Bu çalışma, adrenokortikal tümör (adrenal bez kanseri) olan çocuk ve genç hastalarda sisplatin temelli kemoterapi ve/veya cerrahiyi inceliyor. Son 3 hafta içinde yeni tanı almış, adrenokortikal karsinom doğrulanmış hastalar dahil edilmiştir. Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Tamamlandı

Sponsor

Children's Oncology Group

Müdahale

Cisplatin, Conventional Surgery, Doxorubicin Hydrochloride, Etoposide, Filgrastim, Mitotane, Pegfilgrastim

Başlangıç

03.05.2007

Tahmini bitiş

30.06.2023

Ülkeler

United States, Australia, Brazil, Canada

İlgili genler

Merkezler

• Birmingham, United States
• Birmingham, United States
• Tucson, United States
• Little Rock, United States
• Downey, United States
• Long Beach, United States
• Los Angeles, United States
• Madera, United States
• Orange, United States
• Palo Alto, United States
• Aurora, United States
• Denver, United States
• Farmington, United States
• Hartford, United States
• Wilmington, United States
• Washington D.C., United States
• Fort Myers, United States
• Jacksonville, United States
• Miami, United States
• Orlando, United States
• Pensacola, United States
• Pensacola, United States
• St. Petersburg, United States
• Tampa, United States
• West Palm Beach, United States
• Honolulu, United States
• Chicago, United States
• Chicago, United States
• Peoria, United States
• Springfield, United States
• Indianapolis, United States
• Indianapolis, United States
• Lexington, United States
• Louisville, United States
• New Orleans, United States
• Baltimore, United States
• Bethesda, United States
• Boston, United States
• Detroit, United States
• East Lansing, United States

+51

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Histologically confirmed adrenocortical carcinoma

  * Newly diagnosed disease within the past 3 weeks
  * Any disease stage allowed
* Lansky performance status 60-100% (for patients ≤ 16 years old)
* Karnofsky performance status 60-100% (for patients \> 16 years old)
* Absolute neutrophil count ≥ 750/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age as follows:

  * 0.4 mg/dL (1 month to \< 6 months)
  * 0.5 mg/dL (6 months to \< 1 year of age)
  * 0.6 mg/dL (1 to \< 2 years of age
  * 0.8 mg/dL (2 to \< 6 years of age)
  * 1.0 mg/dL (6 to \< 10 years of age)
  * 1.2 mg/dL (10 to \< 13 years of age)
  * 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to \< 16 years of age)
  * 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST or ALT \< 2.5 times ULN
* Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No previous chemotherapy for adrenocortical carcinoma