ACTRN12618001236280招募中3 期
A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 14 Years 至 o limit（—）
- 性别
- Male
入选标准
- •1. Documentation of Disease
- •- Histologic Documentation: Confirmation of GCT histology (both seminoma and nonseminoma) on pathologic review at the center of enrollment.
- •- Tumor may have originated in any primary site. NOTE: In rare circumstances, patients will be allowed to enroll even if a pathological diagnosis may not have been established.
- •- This would require a clinical situation consistent with the diagnosis of GCT (testicular, peritoneal, retroperitoneal or mediastinal mass, elevated tumor marker levels {HCG greater than or equal to 500; AFP greater than or equal to 500} and typical pattern of metastases)
- •2. Evidence of Disease
- •- Must have evidence of progressive or recurrent GCT (measurable or non-measurable) following one line of cisplatin-based chemotherapy, defined as meeting at least one of the following criteria:
- •* Tumor biopsy of new or growing or unresectable lesions demonstrating viable non-teratomatous GCT (enrollment on this study for adjuvant treatment after macroscopically complete resection of viable GCT is not allowed). In the event of an incomplete gross resection where viable GCT is found, patients will be considered eligible for the study.
- •* Consecutive elevated serum tumor markers (HCG or AFP) that are increasing. Increase of an elevated LDH alone does not constitute progressive disease.
- •* Development of new or enlarging lesions in the setting of persistently elevated HCG or AFP, even if the HCG and AFP are not continuing to increase.
- •3. Prior Treatment
- •- Must have received 3-6 cycles of cisplatin-based chemotherapy as part of first-line (initial) chemotherapy.
- •* Prior POMBACE, CBOP-BEP, or GAMEC are allowed.
- •* Note: For patients requiring immediate treatment, 1 cycle of conventional-dose salvage chemotherapy is allowed. Therefore, these patients may have received 7 prior cycles of chemotherapy. 6 cycles as part of first-line chemotherapy and 1 cycle of salvage conventional chemotherapy.
- •- No more than one prior line of chemotherapy for GCT (other than the 1 cycle of salvage chemotherapy)
- •* Definition of one line of chemotherapy: One line of therapy can in some cases consist of 2 different cisplatin-based treatment combinations, provided there is no disease progression between these two regimens.
- •* Prior treatment with carboplatin as adjuvant therapy is allowed, provided patients meet other eligibility criteria (e.g., the patient has also received 3-4 cycles of cisplatin-based chemotherapy).
- •* Prior treatment with 1-2 cycles of BEP or EP as adjuvant chemotherapy for early stage GCT is allowed, provided the patient also received 3-4 cycles of BEP or EP again at relapse. Patients treated with 3-4 cycles of VIP at relapse following 1-2 cycles of BEP/EP are not eligible as this would be considered more than 1 line of prior therapy.
- •- No prior treatment with high-dose chemotherapy (defined as treatment utilizing stem cell rescue)
- •- No prior treatment with TIP with the exception when given as a bridge to treatment on protocol for patients with rapidly progressive disease who cannot wait to complete the eligibility screening process. Only one cycle is allowed.
- •- No concurrent treatment with other cytotoxic drugs or targeted therapies.
- •No radiation therapy (other than to the brain) within 14 days of day 1 of protocol chemotherapy except radiation to brain metastases, which must be completed 7 days prior to start of chemotherapy.
- •- No previous chemotherapy within 17 days prior to
排除标准
- •1. Prior treatment with high-dose chemotherapy
- •2. Prior treatment with TIP
- •*1 cycle of Prior TIP is allowed as bridge to the protocol
- •3. Prior radiation within 14 days
- •4. Prior chemotherapy within 16 days (bleomycin within 5 days)
- •5. Inadequate recovery from prior surgery
- •6. Concurrent malignancy
- •7. Large hemorrhagic or symptomatic brain metastases
- •*Become eligible 7 days or more after local treatment (surgery or RT)
- •8. Fully resectable late relapse (2 years or more before relapse)
- •9. Concurrent malignancy
研究者
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