Phase II Clinical Trial With Metronomic Oral Vinorelbine and Tri-weekly Cisplatin as Induction Therapy and Subsequent Concomitantly With Radiotherapy (RT) in Patients With Lung Cancer (NSCLC) Locally Advanced Unresectable
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 18
- 主要终点
- Progression-free Survival
研究概览
简要总结
Phase II clinical trial with metronomic oral vinorelbine and tri-weekly cisplatin as induction therapy and subsequent concomitantly with radiotherapy (RT) in patients with lung cancer (NSCLC) locally advanced unresectable
详细描述
Hypothesis
At present, administration of concomitant chemotherapy and radiation therapy is considered a treatment of choice for patients with unresectable stage III tumor selected clinically.
There is at present a systemic considered standard treatment in combination with radical radiotherapy. Nor is it established a dose of standard radiation therapy, but it is known that should never be less than 60Gy57.
Vinorelbine has shown a strong radio-sensitizer in-vitro37 effect. In the phase II study, The combination of oral vinorelbine with cisplatin as induction therapy and then concomitantly with radiotherapy (66Gy) has provided very encouraging efficacy results. Recently in the vortex scheme cisplatin study with oral vinorelbine concomitant maintained with radiation from the second cycle of chemotherapy was tested.
It is therefore a priority in this segment pathology seeking treatment regimens that improve the effectiveness and toxicity. Metronomic chemotherapy started with the idea of administering a cytostatic divided doses, for an extended period without interruption, can provide the advantage of exposing patients to significant dose chemotherapy without worsening the toxicity profile. All this makes it an attractive treatment strategy, and can also maintain radio sensitizing effect during concomitance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Weight loss> 10% in the 3 months prior to study entry.
- •Intestinal problems that do not ensure proper absorption of oral vinorelbine.
- •Pregnant or lactating women. Women of childbearing potential should have a negative pregnancy test, and both men and women under this condition should take contraceptive measures throughout the study.
- •symptomatic sensory neuropathy> grade 1 toxicity criteria according to the CTCAE v
- •Comorbidities uncontrolled.
- •syndrome of the superior vena cava.
- •pleural or pericardial effusion: are both considered as indicative of metastatic disease unless proven otherwise. Those who still remain cytologically negative for malignancy, are exudates also be excluded. It may include those with pleural effusion visible on chest radiography or too small to perform diagnostic puncture safely.
- •Known hypersensitivity to drugs with similar study drug structure.
- •Previous treatment with anticancer drugs, previous surgery or thoracic radiotherapy for lung cancer or for other reasons.
- •History of other malignancy treated properly within 5 years except carcinoma in situ of the cervix or breast skin and basal cell carcinoma.
- •Concomitant treatment with other antineoplastic drug or investigational.
- •Patients at any psychological, family, sociological or geographical that may hinder compliance with the study protocol and monitoring program.
- •history of neurological or psychiatric disorders that impede a properly understanding of the informed consent.
研究组 & 干预措施
1 Experimental group
2 cycles of metronomic Vinorelbine 50 mg + cisplatin, followed by 2 cycles of Vinorelbine 30 mg + cisplatin concomitant with radiotherapy
Induction chemotherapy:
- Cisplatin: 80 mg/m2 day 1 every 21 days, for 2 cycles.
- Metronomic oral vinorelbine: 50mg/day, 3 days of each week for 2 cycles.
Concomitant chemotherapy and radiotherapy:
- Cisplatin: 80 mg/m2 day 1 every 21 days, for 2 cycles.
- Metronomic oral vinorelbine: 30mg/day, 3 days of each week for 2 cycles. 1 cycle equals 21 days
Radiotherapy treatment:
Patients will receive concomitant thoracic radiation therapy, using a technique three-dimensional conformal radiation therapy, using an accelerator linear that operates with energy rays ≥ 6 MV. The total target RTT dose will be 66 Gy in 33 daily fractions of 2 Gy, which will be prescribed in accordance with the document of ICRU reference 50 of ICRU.
干预措施: Vinorelbine (Drug)
1 Experimental group
2 cycles of metronomic Vinorelbine 50 mg + cisplatin, followed by 2 cycles of Vinorelbine 30 mg + cisplatin concomitant with radiotherapy
Induction chemotherapy:
- Cisplatin: 80 mg/m2 day 1 every 21 days, for 2 cycles.
- Metronomic oral vinorelbine: 50mg/day, 3 days of each week for 2 cycles.
Concomitant chemotherapy and radiotherapy:
- Cisplatin: 80 mg/m2 day 1 every 21 days, for 2 cycles.
- Metronomic oral vinorelbine: 30mg/day, 3 days of each week for 2 cycles. 1 cycle equals 21 days
Radiotherapy treatment:
Patients will receive concomitant thoracic radiation therapy, using a technique three-dimensional conformal radiation therapy, using an accelerator linear that operates with energy rays ≥ 6 MV. The total target RTT dose will be 66 Gy in 33 daily fractions of 2 Gy, which will be prescribed in accordance with the document of ICRU reference 50 of ICRU.
干预措施: Cisplatin (Drug)
1 Experimental group
2 cycles of metronomic Vinorelbine 50 mg + cisplatin, followed by 2 cycles of Vinorelbine 30 mg + cisplatin concomitant with radiotherapy
Induction chemotherapy:
- Cisplatin: 80 mg/m2 day 1 every 21 days, for 2 cycles.
- Metronomic oral vinorelbine: 50mg/day, 3 days of each week for 2 cycles.
Concomitant chemotherapy and radiotherapy:
- Cisplatin: 80 mg/m2 day 1 every 21 days, for 2 cycles.
- Metronomic oral vinorelbine: 30mg/day, 3 days of each week for 2 cycles. 1 cycle equals 21 days
Radiotherapy treatment:
Patients will receive concomitant thoracic radiation therapy, using a technique three-dimensional conformal radiation therapy, using an accelerator linear that operates with energy rays ≥ 6 MV. The total target RTT dose will be 66 Gy in 33 daily fractions of 2 Gy, which will be prescribed in accordance with the document of ICRU reference 50 of ICRU.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Progression-free Survival
时间窗: From patient inclusion up to the date of first documented progression or date of death from any cause, whichever came first, up to 24 months.
To evaluate the efficacy in terms of progression-free survival (PFS) of oral metronomical vinorelbine and cisplatin as an induction treatment and then with concomitant radiotherapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions The PFS is defined as the time from the moment of patient inclusion to the documentation of progression or death from any cause (patients who die without evidence of progression, will be considered events on the date of death).
次要结局
- Objective Response Rate 6 Month(From the start of the treatment of the patient to 6 month afther the treatment end)
- Overall Survival (Estimated)(From the date of randomization until end of follow up or death, up to 24 months.)