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.
18 Years
N/A
Both
Non Small Cell Lung Cancer
Trial Information
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.
Inclusion Criteria:
- Ability to understand and the willingness to sign a written informed consent
document.
- Histologically or cytologically confirmed Non-Small Cell Cancer, Stage IIIB or IV.
- Age should be 18 years or above.
- ECOG should be in 0-1 range.
- Absolute neutrophil count ≥ 1,00,000/mm3
- hemoglobin ≥ 9.0g/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)range of institution (5times ULN
if liver metastasis present).
- bilirubin not greater than 1.5 times ULN range of institution (3 times ULN if liver
involvement).
- Creatinine ≤ upper limit of normal (ULN) range of institution.
- Negative pregnancy test for women of child bearing potential prior to entry into the
trial.
Exclusion Criteria:
- Patient who have cytotoxic chemotherapy or radiotherapy prior to entering the study
- Patient with systematic brain metastasis.
- History of allergic reaction attributed to paclitaxel, cisplatin or mycobacterium w
or any of their ingredients.
- Pregnant women or nursing women.
- Uncontrolled intercurrent illness that would limit compliance with study
requirements.
- HIV positive patients.
- Previous splenectomy.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival time of patients, quality of life
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
R K Chaudhary, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Acharya Tulsi Regional Cancer Treatment & Research Institute
Authority:
India: Drugs Controller General of India
Study ID:
CR-60/7260
NCT ID:
NCT00680940
Start Date:
June 2008
Completion Date:
December 2010
Related Keywords:
- Non Small Cell Lung Cancer
- NSCLC
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Mycobacterium Infections
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