Open Label, Randomized Multicentric Phase II Clinical Trial of Mycobacterium w in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel and Cisplatin in Advanced Non Small Cell Lung Cancer.
Non-small cell lung cancer (NSCLC) accounts for 75% of all lung cancers. majority of
patients of NSCLC patients are stage IIIA or IIIB patients are suitable for radiotherapy,
which could not improve the survival rates of 5-10%. This study proposed Mycobacterium w
(heat killed) in combination chemotherapy of Cisplatin and Paclitaxel along with
radiotherapy for adjuvant therapy management of NSCLC in controlled clinical trial, which
may prove the efficacy, better survival rate and quality of life.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival time of patients, quality of life
R K Chaudhary, MD
Acharya Tulsi Regional Cancer Treatment & Research Institute
India: Drugs Controller General of India