TC or BEP in Treating Patients With Malignant Ovarian Germ Cell Tumors

Официальное название

A Multicenter, Prospective, Randomized Trial Comparing Paclitaxel and Carboplatin or Bleomycin, Etoposide and Cisplatin in the Treatment of Malignant Ovarian Germ Cell Tumors

Обзор

Investigators will conduct the trial to determine whether paclitaxel and cisplatin (PT) has the same curative effects and less adverse effects than bleomycin, etoposide and cisplatin(BEP) among newly diagnosed malignant ovarian germ cell tumor patients after surgery.

Подробное описание

PRIMARY OBJECTIVES:

To assess the activity of paclitaxel and carboplatin with respect to progression free survival (using bleomycin, etoposide, and cisplatin \[BEP\] as a reference) for newly diagnosed malignant ovarian germ cell tumors.

SECONDARY OBJECTIVES:

1. To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population. 2. To estimate overall survival for paclitaxel and carboplatin relative to that of BEP. 3. To evaluate response rate in the subset of patients with measurable disease. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

ARM 1: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients receive bleomycin IM daily for days 1-3, etoposide IV daily for days 1-5, cisplatin IV for days 1-5. Treatment repeats every 21 days for 3 or 4\* courses in the absence of disease progression or unacceptable toxicity.

NOTE: \*Patients who have good risk will have 3 courses and those who have poor risks will have 4 courses.

Patients undergo blood sample collection at baseline and periodically during study for laboratory biomarker analysis.

After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Вмешательства

• Препарат Paclitaxel
  Patients receive paclitaxel 175mg/㎡ IV over 3 hours on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
• Препарат Carboplatin
  and carboplatin AUC 5-6 IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
• Препарат Bleomycin
  Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles.
• Препарат Etoposide
  Etoposide 100mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles.
• Препарат Cisplatin
  Cisplatin 20mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity.

Первичные конечные точки

• Progression-free survival [Срок оценки: Date of randomization, and death due to any cause, assessed up to 5 years]

Вторичные конечные точки (3)

• Chemotherapy related adverse effects in two arms [Срок оценки: Up to 5 years]
• Tumor response rate [Срок оценки: Up to 5 years]
• Overall survival [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• Age≤65 years; female, Chinese women;
• Histologically confirmed ovarian stromal tumor, including the following cell types:

• Granulosa cell tumor
• Granulosa cell-theca cell tumor
• Sertoli-Leydig cell tumor (androblastoma)
• Steroid (lipid) cell tumor
• Gynandroblastoma
• Unclassified sex cord-stromal tumor
• Sex cord tumor with annular tubules
• Newly diagnosed, stage IIA-IVB disease;

• Has undergone initial surgery (for diagnosis, staging, or cytoreduction) within the past 8 weeks.
• May or may not have measurable residual disease.
• Laboratory tests: WBC≥4×10(9)/L, NEU≥2×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal
• Performance status: Karnofsky score≥60;
• Provide written informed consent.

Критерии исключения

• With severe or uncontrolled internal disease, unable to receive surgery and/or unsuitable for chemotherapy;
• History of organ transplantation, immune diseases;
• History of serious mental illness, a history of brain dysfunction;
• Drug abuse or a history of drug abuse;
• Suffering from other malignancies;
• Concurrently participating in other clinical trials
• Unable or unwilling to sign informed consents;
• Unable or unwilling to abide by protocol.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Qilu Hospital of Shandong University — Цзинань

Идентификаторы

NCT: NCT02429687 · MOGCT-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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