A randomized phase II study to evaluate the efficacy and safety of chemotherapy (CT) vs androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic, androgen receptor (AR) expressing, salivary gland cancer (SGCs)

European Organisation for Research and Treatment of Cancer (EORTC)0 个研究点目标入组 452 人开始时间: 2014年7月16日最近更新: 2024年5月21日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 452

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•At patient registration step:
•- Histologically proven diagnosis of recurrent and/or metastatic salivary duct cancer; adenocarcinoma NOS; and androgen receptor expression level of = 6 in nuclei of neoplastic cells based on central review. Sufficient tissue must be available either from a historical sample or a new biopsy must be done as a part of this study and sent for central review for patients to be enrolled in both cohorts;
•- Presence of at least one uni-dimensional measurable lesion by CT-scan or MRI according to RECIST criteria version 1.1 (target lesion). A lesion previously treated with radiotherapy can be chosen as a target lesion only if progression in the respective lesion has been demonstrated during or following radiotherapy;
•- Patients older than 18 years old;
•- Performance Status ECOG 0-1;
•- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
•At patient enrollment step:
•- Central pathology confirmation of androgen receptor expression
•- Adequate bone marrow function (within 2 weeks prior to treatment start):
•WBC = 3.5/109L
•absolute neutrophil count = 1,5x109/L
•hemoglobin > 10 g/dL or > 6.20 mmol/L
•platelet count = 100x109/L
•- Adequate liver function (within 2 weeks prior to treatment start):
•AST < 2.5 times upper limit of normal
•ALT < 2.5 times upper limit of normal
•bilirubin < 1.5 times upper limit of normal
•- Adequate renal function (within 2 weeks prior to treatment start):
•serum creatinine level (= 1.3 mg/dL)
•calculated creatinine clearance = 60 mL/min based on the standard Cockcroft and Gault formula (Appendix C)
•- Adequate cardiac function as demonstrated by a clinically normal 12 lead ECG. Additionally for patients who will receive Cisplatin and Doxorubicin adequate cardiac function should be demonstrated by a left ventricular ejection fraction (LVEF) = 50% (within 2 weeks prior to treatment start).
•- Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 1 week prior to the first dose of study treatment;
•- Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly; women should not breastfeed a baby while on this study.
•Specific for Cohort A:
•No previous chemotherapy for recurrent/metastatic disease (previous chemotherapy given concomitantly with RT in the past is allowed, including cisplatin but it should be completed at least 6 months before enrollment).
•Specific to Cohort B:
•Patients who received chemotherapy for recurrent and metastatic disease and subsequently progress will be included in this cohort.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 226
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 226

排除标准

•At patient registration step:
•- Patients with bone disease or brain disease as the sole disease site; brain metastases are allowed in the case of systemic disease, but must have been treated at least 4 weeks before enrollment and must be stable thereafter;
•- No cardiac abnormalities as demonstrated by:
•recent history of congestive heart failure
•unstable angina within the past 3 months
•cardiac arrhythmia
•myocardial infarction
•congenital long QTc prolongation
•TIA within the past 6 months;
•? History of allergic reactions attributed to compounds of similar chemical or biological composition to cis/carboplatin, paclitaxel, doxorubicin, bicalutamide or triptorelin;
•- Active second malignancy during the last five years except non melanomatous skin cancer or carcinoma in situ of the cervix;
•- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
•At patient enrollment step:
•- Participation in another interventional clinical trial in the preceding 4 weeks prior to enrollment

研究者

发起方

European Organisation for Research and Treatment of Cancer (EORTC)

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