PER-081-08已完成未知
CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer
EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),0 个研究点目标入组 0 人开始时间: 2009年3月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 0（—）
- 性别
- Male
入选标准
- •Histologically or cytologically confirmed prostate cancer
- •Metastatic disease
- •On androgen-deprivation therapy for < 120 days
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- •PS 2 eligible only if decline in PS is due to metastatic prostate cancer
- •Absolute neutrophil count = 1,500/mm^3
- •Platelet count = 100,000/mm3
- •Bilirubin = upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) = 2.5 times ULN
- •Creatinine clearance = 30 mL/min
- •Prothrombin time (PT) and international normalized ratio (INR) = 1.5 times ULN (unless on therapeutic anticoagulation)
- •Partial thromboplastin time (PTT) = 1.5 times ULN (unless on therapeutic anticoagulation)
- •Fertile patients must use effective contraception
- •At least 4 weeks since prior major surgery and recovered from all toxicity prior to randomization
- •Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following are true: Therapy was discontinued = 12 months ago AND there is no evidence of disease, as defined by 1 of the following: PSA < 0.1 ng/dL after prostatectomy plus hormonal therapy, PSA < 0.5 ng/dL and has not doubled above nadir after radiotherapy plus hormonal therapy. Therapy lasted no more than 24 months
- •Last depot injection must have expired by the 24-month mark
- •Prior palliative radiotherapy allowed if commenced within 30 days before starting androgen deprivation
- •Anti-androgen therapy allowed as single-agent therapy = 7 days before medial castration to prevent flare
- •More than 30 days (or 6 half-lives) (whichever is longer) since prior participation in another clinical trial
- •Concurrent participation in nontherapeutic trials allowed
- •Concurrent antiandrogen therapy (e.g., bicalutamide or flutamide) allowed, but not as sole hormonal therapy
排除标准
- •Prostate-specific antigen (PSA) level has risen and met criteria for progression from its lowest point between the start of androgen-deprivation therapy and randomization
- •Prior malignancy in the past 5 years except for basal cell or squamous cell carcinoma of the skin
- •Other malignancies that are considered to have low potential to progress (e.g., grade 2, T1a transitional cell carcinoma) may be allowed if approved by study chair
- •Peripheral neuropathy > grade 1
- •History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- •Active cardiac disease, including the following:
- •Active angina
- •Symptomatic congestive heart failure
- •Myocardial infarction within the past 6 months
- •Prior chemotherapy in adjuvant or neoadjuvant setting
- •Prior hormone therapy in the metastatic setting
- •Concurrent 5-alpha reductase inhibitors
- •Simultaneous enrollment on Cancer and Leukemia Group B (CALGB) 90202
研究者
相似试验
已完成
3 期
Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate CancerMetastatic Hormone-sensitive Prostate CancerNCT00309985ECOG-ACRIN Cancer Research Group790
进行中（未招募）
不适用
The CORE Study (Chemotherapy or Endocrine Treatment first?) - COREEUCTR2005-000986-20-DETechnical University of Munich1,500
已完成
2 期
Antiestrogen vs aromatase inhibitor after chemotherapy for adjuvant setting: Efficacy of endocrine therapy after chemotherapy in postoperative adjuvant therapy for breast cancerBreast cancer patients who have received chemotherapy either before or after surgery are the study subjectsJPRN-UMIN000000610Japan Breast Cancer Research Network240
已完成
不适用
The impact of chemotherapy on ovarian reserve in patients with molar pregnancyCondition 1: Hydatidiform mole. Condition 2: molar pregnancy.Neoplasm of uncertain or unknown behaviour: PlacentaHydatidiform mole, unspecifiedNeoplasmsPregnancy,IRCT201104165810N2Private70
尚未招募
不适用
Androgen-deprivation therapy plus abiraterone and prednisolone vs combined androgen blockade for high-risk, metastatic, castration-sensitive prostate cancer : A randomized controlled trialhigh-risk, metastatic, castration-sensitive prostate cancerJPRN-UMIN000035933Osaka General Medical Center50