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The purpose of this study is to determine whether Mycobacterium w in combination with Paclitaxel plus Cisplatin are effective 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy | Active Comparator | Paclitaxel + Cisplatin |
|
| Chemoimmunotherapy | Experimental | Paclitaxel + Cisplatin + Mycobacterium w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel & Cisplatin | Drug | Chemotherapeutic agent |
| |
| Mycobacterium w. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival time of patients, quality of life | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate, Hematological toxicity | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R K Chaudhary, MD | Acharya Tulsi Regional Cancer Treatment & Research Institute | Principal Investigator |
| Rajeev Gupta, MD | Patel Hospital Pvt. Ltd. | Principal Investigator |
| Anup Majumdar, MD | Institute of Post Graduate Medical Education & Research | Principal Investigator |
| A. Rajkumar, MD | V.N. Cancer Center GKNM Hospital | Principal Investigator |
| Rajeev Seam, MD | Regional Cancer center, Indira Gandhi Medical College | Principal Investigator |
| A.K. Patel, MD | Choithram Hospital and Research Centre | Principal Investigator |
| Chanchal Goswami, MD | B.P.Poddar Hospital and Medical Research Ltd. | Principal Investigator |
| Jaydip Biswas, MD | Chittaranjan National Cancer Institute | Principal Investigator |
| Ritwik Pandyea, MD | Netaji Subhash Chandra Bose Cancer Research Institute |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gujarat Cancer & Research Institute, New Civil Hospital Campus | Asarwa | Ahmedabad | 380013 | India | ||
| Regional Cancer Center, Indira Gandhi Medical College |
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| Biological |
Immunomodulator |
|
| Aloke G Dastidar, MD | Bankura Sammilani Medical College | Principal Investigator |
| Narayanankutty Warrier, MD | Malabar Institute of Medical Science (MIMS) | Principal Investigator |
| Ashutosh N Aggarwal, MD | Post Graduate Institute of Medical Education and Research, Chandigarh | Principal Investigator |
| Apurva Patel, MD | Gujarat Cancer & Research Institute | Principal Investigator |
| Santanu Chaudhary, MD | R.S.T. Cancer Hospital & Research Centre | Principal Investigator |
| Rajeev Prasad, MD | Regional Cancer Centre, Indira Ghandhi Institute of Medical Science | Principal Investigator |
| Ramakrishna Malladi, MD | MNJ Institute of Oncology, Regional Cancer Centre | Principal Investigator |
| Shimla |
| Himachal Pradesh |
| 171001 |
| India |
| MNJ Institute of Oncology, Regional Cancer Centre | Red Hills | Hyderabad | 500004 | India |
| Malabar Institute of Medical Science (MIMS) | Calicut | Kerala | 673016 | India |
| B.P. Poddar Hospital and Medical Research Ltd. | New Alipore | Kolkata | 700053 | India |
| Choithram Hospital and Research Centre | Indore | Madhya Pradesh | 452014 | India |
| Regional Cancer Centre, Indira Gandhi Institute of Medical Science | Sheikhpura | Patna | 800014 | India |
| Patel Hospital Pvt. Ltd | Jalandhar | Punjab | 144001 | India |
| Acharya Tulsi Regional Cancer Treatment & Research Institute | Bikaner | Rajasthan | 334003 | India |
| V.N. Cancer Center, GKNM Hospital | Coimbatore | Tamil Nadu | 641037 | India |
| Netaji Subash Chandra Bose Cancer Research Institute | Kolkata | West Bangal | 700016 | India |
| Bankura Sammilani Medical College | Gobindnagar | West Bengal | 722101 | India |
| Institute of Post Graduate Medical education & Research | Kolkata | West Bengal | 700020 | India |
| Chittaranjan National Cancer Institute | Kolkata | West Bengal | 700026 | India |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C111043 | TP protocol |
| C080550 | Mycobacterium w vaccine |
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