NL-OMON50681招募中2 期
A phase II multicenter study comparing the efficacy of the oral angiogenesis inhibitor nintedanib with the intravenous cytotoxic compound ifosfamide for treatment of patients with advanced metastatic soft tissue sarcoma after failure of systemic non-oxazaphosporine-based first line chemotherapy for inoperable disease ANITA - Phase II study comparing nintedanib with ifosfamide in soft tissue sarcoma
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 22 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 22
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 99（—）
入选标准
- •SELECTION CRITERIA, *Written informed consent
- •*Histologically proven advanced, inoperable (medical or surgical) and/or
- •metastatic malignant STS of intermediate or high grade, excluding the following
- •tumor types:
- •* Well-differentiated liposarcoma/atypical lipoma
- •* Embryonal rhabdomyosarcoma
- •* Chondrosarcoma (extraskeletal myxoid chondrosarcoma is eligible)
- •* Osteosarcoma (extraskeletal osteosarcoma is eligible)
- •* Ewing family of tumors/primitive neuroectodermal tumor
- •* Gastro-intestinal stromal tumor
- •* Dermatofibrosarcoma protuberans
- •* For STS where no established grading system exists, or sarcoma subtypes which
- •are very indolent or have an unpredictable clinical behavior, patient entry
- •requires prospective approval in writing, on a case-by-case basis by the Study
- •Coordinator of this trial and EORTC Headquarters (HQ).
- •*Representative formalin fixed, paraffin embedded tumor blocks or unstained
- •tissue slides, either from the primary tumor or a metastatic lesion, must be
- •available for histological central review.
- •* One (and no less or more than one) line of previous systemic chemotherapy for
- •advanced, inoperable and/or metastatic malignant STS. Note: Patients treated in
- •first line with doxorubicin/olaratumab or doxorubicin/placebo +/-
- •olaratumab/placebo maintenance qualify for the trial and such treatment will be
- •considered as one line according to the protocol.
- •* Prior neoadjuvant, adjuvant and or first-line maintenance systemic
- •chemotherapy for locally advanced or metastatic STS is allowed and does
- •count as zero lines of treatment, provided that the disease did not progress
- •during neoadjuvant and/or adjuvant therapy or within 12 weeks after completion
- •of the perioperative treatment. In case the disease progressed during
- •neoadjuvant, adjuvant and or first-line maintenance systemic chemotherapy or
- •within 12 weeks after its
- •completion, the treatment is counted as one line and the patient can
- •theoretically participate in the trial, provided all other selection criteria
- •* Prior to study enrolment, all patients need to have confirmed RECIST 1.1
- •disease progression based on local investigator's assessment.
- •* Presence of measurable disease according to RECIST 1.1.
- •* Age 18 years or older.
- •* WHO performance status (PS) 0-2.
- •* Life expectancy of at least 3 months.
- •Adequate bone marrow, liver and renal function and coagulation parameters:
- •* neutrophils >= 1.5 x 10^9/L;
- •* hemoglobin >= 9 g/dL (or >= 5.6 mmol/L). Blood transfusions or the
- •administration of hematopoietic growth factors are allowed to achieve these
- •baseline values;
- •* platelets >= 100 x 10^9/L. Platelet transfusions or the administration of
- •hematopoietic growth factors are allowed to achieve these baseline values;
- •* Total bilirubin <= ULN;
- •* Patients with Gilbert syndrome and/or bilirubin < 2xULN and normal AST/ALT
- •are eligible;
- •* SGPT/ALT and SGOT/AST <= 2.5 x ULN for patients with liver metastasis;
- •* SGPT/ALT and SGOT/ AST <= 1.5x ULN for patients without liver metastasis;
- 另有 5 项未显示
排除标准
- •See section D4a
研究者
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