Paclitaxel+BEP (T-BEP) vs BEP in Poor-prognosis Non-seminomatous Germ Cell Tumors (NSGCT) and Unfavorable Tumor Marker Decline: Randomized Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1-year progression-free survival (PFS)
研究概览
简要总结
GETUG-13 study has prospectively confirmed poor outcomes in advanced germ cell tumors (GCT) patients with unfavorable decrease of tumor markers after 1 cycle of BEP chemotherapy. There is an unmet medical need to improve outcomes in this subset of patients, however the dose-dense regimen proposed in the above-mentioned trial cannot be implemented in routine clinical practice. T-BEP regimen may have advantage over the traditional BEP regimen as first-line therapy for poor-risk GCT Treatment escalation with T-BEP regimen may be an effective and tolerable therapeutic option for advanced GCT patients with unfavorable tumor markers decline.
详细描述
Screening procedures:
- AFP, b-HCG, LDH - ≤7 days before enrollment;
- Complete blood counts;
- Blood chemistry;
- Urinalysis;
- Chest, abdominal and pelvic CT-scan with IV enhancement;
- Electrocardiogram;
- Brain MRI scan as clinically indicated (neurologic symptoms, post-orchiectomy serum beta-hCG > 5000 IU/L or extensive lung metastasis)
Treatment:
After registration patients will receive first cycle of standard BEP chemotherapy: cisplatin 20 mg/m² IV days 1-5, etoposide 100 mg/m² IV days 1-5, bleomycin 30 mg IV days 1, 8 and 15 OR days 1, 3 and 5 + G-CSF 5 mcg/kg subcutaneous day 6, until post-nadir absolute neutrophil count ≥ 1.0 x 10^9. In patients with ultra-high level of tumor markers and/or poor performance status (eg, ECOG3-4) administration of a disease stabilizing chemotherapy first cycle of chemotherapy is allowed.
After 1st cycle of BEP tumor markers will be reassessed between days 18 and 21, and their kinetics will be centrally calculated (App: Tumor marker decline calculator poor-risk GCT - http://www.gustaveroussy.fr/calculation-tumor/NSGCT.html).
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 单盲 (受试者)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- Age ≥16 years;
- Evidence of NSGCT based on histologic examination or clinical evidence (high serum HCG or AFP levels - in case of clinical emergency due to bulky disease, therapy can be started without pathological confirmation of the disease);
- Testicular, retroperitoneal, or mediastinal primary site;
- Disease classified as poor prognosis according to IGCCCG criteria:
- Primary mediastinal NSGCT or
- Non-pulmonary visceral metastases or
- HCG > 50,000 UI/l, or AFP > 10,000 ng/ml, or LDH > 10 times the upper normal value.
- No prior chemotherapy;
- No concurrent malignancies which may have an impact of anticipated lifespan (ie, malignancies other than basal-cell skin carcinoma, in situ carcinomas, borderline ovarian tumors etc);
- Adequate renal function: measured or calculated glomerular filtration rate > 60 ml/min.
- Absolute baseline granulocyte count ≥0.5*10^9, platelets ≥100*10^9, bilirubin ≤1.5 ULN.
- Unfavorable tumor marker decline after 1st cycle of standard BEP chemotherapy calculated according to time to normalization from the K. Fizazi study in JCO 2004.
- Signed informed consent before protocol-specific procedures.
排除标准
- Primary intracranial germ-cell tumors;
- Patients with seminomas or dysgerminomas;
- Patients with normal range of serum tumor markers before starting treatment;
- Patients with favorable tumor markers decline;
- Patients infected by the Human Immunodeficiency Virus (HIV);
- Patients with contraindications to taxane agents (hypersensitivity to paclitaxel);
- Patients who do not fit inclusion criteria.
研究组 & 干预措施
T-BEP
Participants receive 3 cycles of T-BEP after the first cycle of the BEP regimen and unfavorable tumor marker decline, followed by standard of care surgery. Each cycle is 21 days.
干预措施: G-CSF (Filgrastim) (Drug)
BEP
Participants receive 3 cycles of BEP after the first cycle of the BEP regimen and unfavorable tumor marker decline, followed by standard of care surgery. Each cycle is 21 days.
干预措施: Cisplatin (Drug)
BEP
Participants receive 3 cycles of BEP after the first cycle of the BEP regimen and unfavorable tumor marker decline, followed by standard of care surgery. Each cycle is 21 days.
干预措施: G-CSF (Filgrastim) (Drug)
T-BEP
Participants receive 3 cycles of T-BEP after the first cycle of the BEP regimen and unfavorable tumor marker decline, followed by standard of care surgery. Each cycle is 21 days.
干预措施: Paclitaxel (Drug)
T-BEP
Participants receive 3 cycles of T-BEP after the first cycle of the BEP regimen and unfavorable tumor marker decline, followed by standard of care surgery. Each cycle is 21 days.
干预措施: Bleomycin (Drug)
T-BEP
Participants receive 3 cycles of T-BEP after the first cycle of the BEP regimen and unfavorable tumor marker decline, followed by standard of care surgery. Each cycle is 21 days.
干预措施: Etoposide (Drug)
T-BEP
Participants receive 3 cycles of T-BEP after the first cycle of the BEP regimen and unfavorable tumor marker decline, followed by standard of care surgery. Each cycle is 21 days.
干预措施: Cisplatin (Drug)
BEP
Participants receive 3 cycles of BEP after the first cycle of the BEP regimen and unfavorable tumor marker decline, followed by standard of care surgery. Each cycle is 21 days.
干预措施: Bleomycin (Drug)
BEP
Participants receive 3 cycles of BEP after the first cycle of the BEP regimen and unfavorable tumor marker decline, followed by standard of care surgery. Each cycle is 21 days.
干预措施: Etoposide (Drug)
结局指标
主要结局
1-year progression-free survival (PFS)
时间窗: Time from enrollment to disease progression or relapse or death due to any cause, or data cut-off date at 1 year, whichever occured first (up to ~60 months)
1-year PFS is defined as time from enrollment to disease progression or relapse or death due to any cause at 1 year (12-month PFS)
次要结局
- Overall Survival(Time from enrollment to death due to any cause, or data cut-off date, whichever occurred first (up to ~60 months))
- Complete response rate (CRS)(Time from enrollment to completion of the 4th cycle of chemotherapy, disease progression, or death, whichever occurs first (up to ~48 months))
- Pathological complete response (pCR)(Time from enrollment to death due to any cause, or data cut-off date, whichever occurred first (up to ~60 months))
- Adverse events(Time from enrollment to death due to any cause, or data cut-off date, whichever occurred first (up to ~60 months))
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07847190
- 其他研究编号
- 200896130499
日期
- 首次提交
- (7天前)
- 首次发布
- (昨天)
- 主要完成日期
- (2年后)
- 研究完成日期
- (3年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否