Outcome of Cisplatin and Vinblastine Versus Paclitaxel and Carboplatin as Sequential Chemotherapy Followed by Radiotherapy in Locally Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- tumor response
研究概览
简要总结
Lung cancer is the leading malignancy worldwide and in Bangladesh. Most of the lung cancer is of Non-small Cell Lung Cancer (NSCLC) type. For locally advanced NSCLC, combined modality treatment is required. Concurrent chemo-radiotherapy and sequential chemo-radiotherapy are the two recommended options. Sequential chemo-radiotherapy is mainly practiced in Bangladesh due to its less toxicity profile. There is no head to head comparative study done which focuses on the sequential chemotherapy regimens used in locally advanced NSCLC.
Hypothesis:
Null Hypothesis (H0): Sequential chemotherapy with cisplatin and vinblastine followed by radiotherapy and paclitaxel and carboplatin followed by the same radiotherapy in locally advanced NSCLC, there is no difference in loco-regional tumor control.
Alternative Hypothesis (HA): Sequential chemotherapy with cisplatin and vinblastine followed by radiotherapy and paclitaxel and carboplatin followed by the same radiotherapy in locally advanced NSCLC, cisplatin and vinblastine is more responsive and effective in loco-regional tumor control than paclitaxel and carboplatin.
详细描述
Lung cancer is the leading malignancy worldwide and in Bangladesh. Most of the lung cancer is of Non-small Cell Lung Cancer (NSCLC) type. For locally advanced NSCLC, combined modality treatment is required. Concurrent chemo-radiotherapy and sequential chemo-radiotherapy are the two recommended options. Sequential chemo-radiotherapy is mainly practiced in Bangladesh due to its less toxicity profile. There is no head to head comparative study done which focuses on the sequential chemotherapy regimens used in locally advanced NSCLC.
Aim and Objective:
To compare treatment outcome and acute toxicities between two standard sequential chemotherapy regimens (Cisplatin and Vinblastine followed by radiotherapy and Paclitaxel and Carboplatin followed by same radiotherapy) in patients with locally advanced stage III NSCLC.
Material and Method:
A total number of 60 patients, who are clinically locally advanced (stage III A and III B), histologically proven NSCLC, inoperable and with ECOG performance score upto grade 2 and body weight loss <10 % in 3 months will be included in this study.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients with locally advanced (stage III a, b) non-small cell lung cancer.
- •Patients who are inoperable. Patients Eastern Co-operative Group (ECOG) performance score up to grade 2.
排除标准
- •• Age below 18 years.
- •Patients with history of prior chemotherapy or radiotherapy to lung region.
- •Serious concomitant medical illness including severe heart disease, uncontrolled diabetes mellitus or hypertension.
- •Life expectancy < 6 months.
- •Patient with uncontrolled infection
- •Pregnant or lactating woman.
- •Psychiatric illness.
研究组 & 干预措施
chemotherapy with paclitaxel and carboplatin
Intervention: paclitaxel 200 mg/m2 AUC and carboplatin AUC 6 on day 1 every 3 wks for 2 cycles followed by three dimensional conformal radiotherapy on day 42
干预措施: Paclitaxel (Drug)
chemotherapy with paclitaxel and carboplatin
Intervention: paclitaxel 200 mg/m2 AUC and carboplatin AUC 6 on day 1 every 3 wks for 2 cycles followed by three dimensional conformal radiotherapy on day 42
干预措施: Carboplatin (Drug)
chemotherapy with paclitaxel and carboplatin
Intervention: paclitaxel 200 mg/m2 AUC and carboplatin AUC 6 on day 1 every 3 wks for 2 cycles followed by three dimensional conformal radiotherapy on day 42
干预措施: three dimensional conformal radiotherapy (Radiation)
chemotherapy with cisplatin and vinblastine
Intervention : cisplatin 100 mg/m2 on day 1 and 29 and vinblastine 5mg/m2 on days 1,8,15,22 and 29 followed by three dimensional conformal radiotherapy on day 50
干预措施: Cisplatin (Drug)
chemotherapy with cisplatin and vinblastine
Intervention : cisplatin 100 mg/m2 on day 1 and 29 and vinblastine 5mg/m2 on days 1,8,15,22 and 29 followed by three dimensional conformal radiotherapy on day 50
干预措施: Vinblastine Sulfate (Drug)
chemotherapy with cisplatin and vinblastine
Intervention : cisplatin 100 mg/m2 on day 1 and 29 and vinblastine 5mg/m2 on days 1,8,15,22 and 29 followed by three dimensional conformal radiotherapy on day 50
干预措施: three dimensional conformal radiotherapy (Radiation)
结局指标
主要结局
tumor response
时间窗: 30 weeks
complete response(CR), partial response(PR), progressive disease(PD) and stable disease(SD),Responses Description Complete Response ( CR ) Disappearance of all known diseases, confirmed at ≥ 4 weeks. Partial Response ( PR ) ≥ 50 % decrease from baseline, confirmed at ≥ 4 weeks. Progressive disease ( PD ) ≥ 25 % increase in one or more lesions or appearance of new lesions Stable disease ( SD ) Neither PR or PD criteria met final tumor response will be seen in 30 weeks of starting of completion and will be considered as the primary outcome
次要结局
未报告次要终点
研究者
Anshu Kumar Thakur
MD Oncology program Phase B Resident Doctor,Department of Oncology,Principal investigator.
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh