NCT01303094已完成2 期
Phase II Randomized Trial to Evaluate Two Strategies: Continuing Versus Intermittent (Drug-holiday) Trabectedin-regimen in Patients With Advanced Soft Tissue Sarcoma Experiencing Response or Stable Disease After the Sixth Cycle
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 16
- 主要终点
- PFS rate 24 weeks after randomization
研究概览
简要总结
This randomization discontinuation trial will allow for concomitant evaluation of the following:
- Side effects and benefits of immediate continuation of Trabectedin after the sixth cycle
- Side effects and benefits of a drug holiday
详细描述
Selection part (220 patients):
Trabectedin (depending on dose reductions : between 1.5 and 1 mg/m²/3 weeks; over 24 hour administration) until progression, intolerance or 6 cycles (according to the SPC of Trabectedin)
Randomized part (50 patients):
After the 6 first cycles, if there is not progression or unacceptable toxicity, the patients will be randomly assigned to continuous or "intermittent/holiday" therapy with CT-scan evaluation every 6 weeks in both arms
- Arm A Continuation of Trabectedin (between 1.5 and 1 mg/m²/3 weeks; over 24 hour administration) until progression or intolerance
- Arm B "Intermittent/holiday" therapy. Rechallenge of Trabectedin will be implemented in the event of progression; in this case administration of Trabectedin will occur until the second progression or intolerance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(for the selection part):
- •Inoperable or metastatic soft tissue sarcoma and/or uterine sarcoma
- •Measurable lesions (RECIST 1.1)
- •Performance status ≤ 2
- •Normal hematological parameters (polynuclear neutrophils ≥ 1500, hemoglobin level ≥ 9 g/dl, platelets counts ≥ 100,000)
- •Adequate biological parameters :
- •Adequate hepatic function (bilirubin ≤ ULN , SGPT/ALT and SGOT/AST ≤ 2.5 x ULN)
- •Alkaline phosphatases ≤ 2.5 x ULN, If Alkaline phosphatases ≥ 2.5 ULN, hepatic isoenzymes 5-nucleotidases or GGT tests must be performed; hepatic isoenzymes 5- nucleotidases and/or GGT must be within the normal range
- •Albumin ≥ 25 g/L
- •Adequate renal function : Serum creatinine ≤ 1.5 x ULN
- •Creatine phosphokinase ≤ 2.5 x ULN
- •Adequate central venous access
- •Pregnant or lactating women or men of reproductive potential must use effective contraceptive methods
- •Patient covered by government health insurance
- •Information sheet given to the patient (Patient information sheet 1)
排除标准
- •(for the selection part):
- •Patients that have received more than one regimen of chemotherapy for metastatic or inoperable soft tissue or uterine sarcoma, after the failure/intolerance of doxorubicin and ifosfamide. Maintenance treatment does not count as treatment line
- •The following histological subtypes : GIST, rhabdomyosarcoma, aggressive fibromatosis, desmoïd tumour, PNET, carcinosarcoma, and all bone sarcomas
- •Single tumour in an irradiated region
- •Other malignant tumour over the past five years (except basal cell carcinoma or cervical carcinoma in situ adequately treated)
- •Currently active bacterial or fungus infection (> grade 2 CTC [CTCAE] Version 4.02). Known HIV1, HIV2, hepatitis B or hepatitis C infections
- •Presence of known leptomeningeal or brain metastasis
- •Patients unable to receive corticotherapy
- •Any circumstance that could jeopardise compliance or proper follow-up during the trial
- •Pregnant or nursing women
- •Inclusion Criteria (for the randomized part):
- •Patient registered in the selection part
- •Stable tumour or objective response (CR + PR) after 6 Trabectedin (Yondelis®) cycles, according to local assessment
- •Available copies of thoraco-abdominal and pelvic scan performed prior to the first cycle and after the sixth cycle
- •Performance status ≤ 2
- •Patients receiving at least 1 mg/m²/3 weeks of Trabectedin at the time of the sixth cycle
- •Normal hematological parameters (polynuclear neutrophils ≥ 1500, hemoglobin level ≥ 9 g/dl, platelets counts ≥ 100,000)
- •Adequate biological parameters :
- •Adequate hepatic function (bilirubin ≤ ULN , SGPT/ALT and SGOT/AST ≤ 2.5 x ULN)
- •Alkaline phosphatases ≤ 2.5 x ULN, If Alkaline phosphatases ≥ 2.5 ULN, hepatic isoenzymes 5-nucleotidases or GGT tests must be performed; hepatic isoenzymes 5- nucleotidases and/or GGT must be within the normal range
- •Albumin ≥ 25 g/L
- •Adequate renal function : Serum creatinine ≤ 1.5 x ULN
- •Creatine phosphokinase (CPK) ≤ 2.5 x ULN
- •Adequate central venous access
- •Pregnant or lactating women or men of reproductive potential must use effective contraceptive methods
- •Informed consent form signed by the patient or the patient's legal representative (patient information sheet 2 and informed consent)
- •Exclusion Criteria (for the randomized part):
- •Tumour progression (according to RECIST 1.1) during the first six Yondelis cycles
- •Non-availability of baseline scans prior to the first cycle and following the sixth cycle
- •Currently active bacterial or fungus infection (> grade 2 CTC [CTCAE] Version 4.02). Known HIV1, HIV2, hepatitis B or hepatitis C infections
- •Presence of known leptomeningeal or brain metastasis
- •Creatinine clearance less than 30 ml/min
- •Patients unable to receive corticotherapy
- •Any circumstance that could jeopardise compliance or proper follow-up during the trial
- •Pregnant or nursing women
- •Hypersensitivity to Trabectedin or any excipient in prior cycles
研究组 & 干预措施
"Drug holiday" therapy
Other
patient receives 6 cycles of trabectedin, then one dose 15 days after the 6th cycle and he stops the drug until progression and re-challenge
干预措施: Drug: holiday (Other)
Continuation of Trabectedin
Other
patient receives 6 cycles of trabectedin, then one dose 15 days after the 6th cycle, every 3 weeks until progression/ toxicity
干预措施: Trabectedin (Drug)
结局指标
主要结局
PFS rate 24 weeks after randomization
时间窗: 24 weeks after randomization
In each arms among non progressive patients after the 6 first cycles of Trabectedin : occurrence of progression or death 24 weeks after the date of randomization. Intention to treat analysis. Centralised radiological review.
次要结局
- Survival rates(12 and 24 months after randomization)
- Median progression-free and median overall survivals(Up to 5 years after randomization)
- Post-randomization cost of care(For one year after randomization)
- Progression free survival rates(12 and 54 weeks after randomization)
- Clinical and biological predictive factors for non progression at the 6th cycle(At baseline)
- Self estimation of general health status(For 1 year after randomization)
- Response rate(6, 12 and 18 weeks after randomization)
- Tolerability - safety(Up to 30 days after the last study drg administration)
研究者
研究点 (16)
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