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A Study of Mycobacterium w in Combination With Paclitaxel Plus Cisplatin in Advanced Non Small Cell Lung Cancer

NCT ID: NCT00680940

Last Updated: 2012-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non Small Cell Lung Cancer

Keywords

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NSCLC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemotherapy

Paclitaxel + Cisplatin

Group Type ACTIVE_COMPARATOR

Paclitaxel & Cisplatin

Intervention Type DRUG

Chemotherapeutic agent

Chemoimmunotherapy

Paclitaxel + Cisplatin + Mycobacterium w

Group Type EXPERIMENTAL

Mycobacterium w.

Intervention Type BIOLOGICAL

Immunomodulator

Interventions

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Paclitaxel & Cisplatin

Chemotherapeutic agent

Intervention Type DRUG

Mycobacterium w.

Immunomodulator

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cadila Pharnmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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R K Chaudhary, MD

Role: PRINCIPAL_INVESTIGATOR

Acharya Tulsi Regional Cancer Treatment & Research Institute

Rajeev Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

Patel Hospital Pvt. Ltd.

Anup Majumdar, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Post Graduate Medical Education & Research

A. Rajkumar, MD

Role: PRINCIPAL_INVESTIGATOR

V.N. Cancer Center GKNM Hospital

Rajeev Seam, MD

Role: PRINCIPAL_INVESTIGATOR

Regional Cancer center, Indira Gandhi Medical College

A.K. Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Choithram Hospital and Research Centre

Chanchal Goswami, MD

Role: PRINCIPAL_INVESTIGATOR

B.P.Poddar Hospital and Medical Research Ltd.

Jaydip Biswas, MD

Role: PRINCIPAL_INVESTIGATOR

Chittaranjan National Cancer Institute

Ritwik Pandyea, MD

Role: PRINCIPAL_INVESTIGATOR

Netaji Subhash Chandra Bose Cancer Research Institute

Aloke G Dastidar, MD

Role: PRINCIPAL_INVESTIGATOR

Bankura Sammilani Medical College

Narayanankutty Warrier, MD

Role: PRINCIPAL_INVESTIGATOR

Malabar Institute of Medical Science (MIMS)

Ashutosh N Aggarwal, MD

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Apurva Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Gujarat Cancer & Research Institute

Santanu Chaudhary, MD

Role: PRINCIPAL_INVESTIGATOR

R.S.T. Cancer Hospital & Research Centre

Rajeev Prasad, MD

Role: PRINCIPAL_INVESTIGATOR

Regional Cancer Centre, Indira Ghandhi Institute of Medical Science

Ramakrishna Malladi, MD

Role: PRINCIPAL_INVESTIGATOR

MNJ Institute of Oncology, Regional Cancer Centre

Locations

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Gujarat Cancer & Research Institute, New Civil Hospital Campus

Asarwa, Ahmedabad, India

Site Status

Regional Cancer Center, Indira Gandhi Medical College

Shimla, Himachal Pradesh, India

Site Status

MNJ Institute of Oncology, Regional Cancer Centre

Red Hills, Hyderabad, India

Site Status

Malabar Institute of Medical Science (MIMS)

Calicut, Kerala, India

Site Status

B.P. Poddar Hospital and Medical Research Ltd.

New Alipore, Kolkata, India

Site Status

Choithram Hospital and Research Centre

Indore, Madhya Pradesh, India

Site Status

Regional Cancer Centre, Indira Gandhi Institute of Medical Science

Sheikhpura, Patna, India

Site Status

Patel Hospital Pvt. Ltd

Jalandhar, Punjab, India

Site Status

Acharya Tulsi Regional Cancer Treatment & Research Institute

Bikaner, Rajasthan, India

Site Status

V.N. Cancer Center, GKNM Hospital

Coimbatore, Tamil Nadu, India

Site Status

Netaji Subash Chandra Bose Cancer Research Institute

Kolkata, West Bangal, India

Site Status

Bankura Sammilani Medical College

Gobindnagar, West Bengal, India

Site Status

Institute of Post Graduate Medical education & Research

Kolkata, West Bengal, India

Site Status

Chittaranjan National Cancer Institute

Kolkata, West Bengal, India

Site Status

Countries

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India

Other Identifiers

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CR-60/7260

Identifier Type: -

Identifier Source: org_study_id