drugset / Trial / NCT03092986

Outcome of Cisplatin and Vinblastine Versus Paclitaxel and Carboplatin as Sequential Chemotherapy Followed by Radiotherapy in Locally Advanced Non-small Cell Lung Cancer

NCT03092986

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2017-01-01
Primary completion
2018-06-01
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule Intravenous
Subject Cisplatin Other / unclassified 100 mg/m2 Intravenous
Comparator Paclitaxel Small molecule 200 mg/m2 Intravenous
Subject Vinblastine Small molecule 5 mg/m2 Intravenous