| CTRI Number |
CTRI/2007/091/000037 [Registered on: 01/10/2009] |
| Last Modified On: |
23/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Vaccine |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Clinical trial of Mycobacterium w in Combination with
Paclitaxel and Cisplatin in Advanced non small cell lung cancer patients.
|
Scientific Title of Study
Modification(s)
|
Open label, randomized multicentric clinical trial of Mycobacterium w in combination with Paclitaxel plus Cisplatin versus paclitxel and cisplatin in advanced Non Small Cell Lung Cancer. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CR-60/7260 Version 1.2 Dated 25 June 2008 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Anup Majumdar |
| Designation |
Head, Department of Radiotherapy |
| Affiliation |
Institute of Post Graduate Medical Education & Research |
| Address |
Institute of Post Graduate Medical Education & Research, 244, A.J.C.Bose Road, Kolkata-700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
913322236287 |
| Fax |
|
| Email |
anup.majumdar@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ashish Akar |
| Designation |
Manager |
| Affiliation |
Cadila pharmaceuticals ltd. |
| Address |
CRO division, Cadila pharmaceutical Limited, 1389, Trasad road, Dholka, Ahmedabad – 382225,Gujarat, India..
Ahmadabad
GUJARAT
382225
India |
| Phone |
912714221481 |
| Fax |
02714221848 |
| Email |
ashish.akar@cadilapharma.co.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Bhaumik Mody |
| Designation |
Manager |
| Affiliation |
Cadila pharmaceuticals ltd |
| Address |
CRO Division, Cadila Pharmaceuticals Limited,
1389, Trasad Road, Dholka, Ahmedabad – 382225,
Gujarat, India.
Ahmadabad
GUJARAT
382225
India |
| Phone |
02714-221481 |
| Fax |
02714-221848 |
| Email |
bhaumik.mody@cadilapharma.co.in |
|
Source of Monetary or Material Support
Modification(s)
|
| Cadila Pharmaceuticals ltd.
Cadila Corporate Campus, Sarkhej Dholka Road, Bhat, Ahmedabad 382210, Gujarat, India. |
|
Primary Sponsor
Modification(s)
|
| Name |
Cadila Pharmaceuticals ltd |
| Address |
Sarkhej – Dholka Road, Bhat, Ahmedabad – 382 210, (Gujarat – India) Phone : +91-2718-225001 (15 Lines) Fax: +91-2718-225039 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 17 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr R K Choudhary |
Acharya Tulsi Regional Cancer Treatment & Research Institute |
Department of medical oncology,BIKANER,-334003
Bikaner
RAJASTHAN |
0151-2226329
drrkchouddhary@rediffmail.com |
| Dr Chanchal Goswami |
B.P.Poddar Hospital & Medical Research Ltd. |
Department of oncology, 71/1, Humayu kabir, Sarani, new ali pore, Block G,-700053
|
09830055035
saptarshi1970@yahoo.com |
| Dr Alok Ghosh Dastidar |
bankura Sammilani Medical College and Hospital |
Department of oncology, bankura Sammilani Medical College and Hospital, Gobindnagar,-722102
Bankura
WEST BENGAL |
0981118494
alokeghoshdastidar@yahoo.com |
| Dr BR Srivastava |
Cancer Hospital & Research Centre |
Department of oncology. Jan Vikas Nyas,Mandre Ki Mata-Gwalior-474009. MP. India.
Gwalior
MADHYA PRADESH |
0751-2336502
0751-2336506
br_shrivastav08@yahoo.com |
| Dr Jaydip Biswas |
Chitranjan National Cancer Institute |
Department of Oncology, 37, SP Mukherji Road,,-700026
|
09830026696
drjbiswas.cnci@gmail.com |
| Dr Aarti Kaul Patel |
Choithram Hospital & Research Centre |
Department of Radiotherapy,Choithram Hospital & Research Centre, Manik baug road, ,-452014
Indore
MADHYA PRADESH |
09406617331
aartikaul7@gmail.com |
| Dr Apurva Patel |
Gujarat Cancer Research Institute |
Department of Oncology, GCRI, Asarwa, Ahmedabad,-380024
Ahmadabad
GUJARAT |
09898498320
jay.clinicalresearch@yahoo.com |
| Dr Anup Majumdar |
Institute of Post Graduation medical education & research centre |
Department of Radiotherapy, 244/AJC, Bose Road,-700020
Kolkata
WEST BENGAL |
09883083052
anup.majumdar@gmail.com |
| Dr Narayan kutty |
Malabar Institute of medical science |
Department of Oncology. mini bypass road, P.O. Box, Govindapuram ,-16
Kozhikode
KERALA |
09447154208
n_goray@rediffmail.com |
| Dr M Ramakrishna |
MNJ Institute of Oncology, |
Department of oncology. MNJ Institute of Oncology,RCC Red Hills, Hyderabad-500004. India.
Hyderabad
TELANGANA |
040-23318414
040-23314063
rkmalladi@yahoo.com |
| Dr Ritwik Pandey |
Netaji Subhash Chandra Bose Cancer Research Institute |
Department of oncology. 16A Park Lane, Kolkata-700016
Kolkata
WEST BENGAL |
033-22291049
somashis@vsnl.net |
| Dr Rajeev Gupta |
Patel Hospital Pvt. Ltd |
Department of medical oncology, Civil Lines Jalandhar- 144 001
Jalandhar
PUNJAB |
0181-3041034
drajoshi@gmail.com |
| Dr Ashutosh Aggarwal |
PGI, Chandigadh |
Department of oncology. Post graduate institute of medical education and research,Chandigarh-160012
Chandigarh
CHANDIGARH |
09876105648
aggarwal.ashutosh@indiachest.org |
| Dr Santanu Chaudhuri |
R.S.T. Regional Cancer Hospital & Research Centre |
Department of oncology. Manewada Road,-440003
Nagpur
MAHARASHTRA |
0712-2748995
0712-2754546
chaudhurisantanu@hotmail.com |
| Dr Rajeev Seam |
RCC, Shimla |
Department of medical oncology, Choithram Hospital & Research Centre, Indira gandhi Medical College, ,-171001
Shimla
HIMACHAL PRADESH |
09418470607
rajeevseam@yahoo.com |
| Dr Rajeev Ranjan Prasad |
Regional Cancer Centre |
Department of oncology. Indira Gandhi Institute of Medical Science,Sheikhpura-800014
Patna
BIHAR |
0612-2295116
0612-2295116
rajiv_rprasad@yahoo.com |
| Dr A Rajkumar |
V. N. Cancer Centre, G.K.N.M. |
Department of Medical Oncology,V. N. Cancer Centre, G.K.N.M. P.N.Palyam,-641037
Coimbatore
TAMIL NADU |
09894663864
draprince@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 17 |
| Name of Committee |
Approval Status |
| EC, "Choithram Hospital & Research Centre, Manik Bagh Road, Indore |
Approved |
| IEC, "Chittaranjan National Cancer Institute, 37, S. P. Mukherjee Road, Kolkata-700 026 |
Approved |
| IEC, "Clinical Trial Wing, 3rd Floor of Paediatrics cancer hospital, Gujarat Cancer & Research Institute, Asarwa,Ahmedabad. |
Approved |
| IEC, "Regional Cancer Centre, Indira Gandhi Medical College, Shimla- 171 001 |
Approved |
| IEC, "V.N Cancer Centre, G.K.N.M. Hospital, P.N Palyam, Coimbatore- 641 037 |
Approved |
| IEC, B. P. Poddar Hospital & Medical Research Ltd., Kolkata |
Approved |
| IEC, Bankura Sammilani Medical College & Hospital, Gobidanagar, Bankura - 722102, West Bengal. |
Approved |
| IEC, Cancer Hospital & Research Centre, Jan Vikas Nyas, Mandre Ki Mata, Gwalior-474009, M.P. |
Approved |
| IEC, Department of Medical Oncology,Malabar Institute of Medical Science (MIMS),Minibypass Road P.O, Govindapuram,Calicut-16, Kerala |
Approved |
| IEC, Institute of Post Graduate Medical Education & Research, Kolkata |
Approved |
| IEC, MNJ Institute of Oncology, RCC Red Hills, Hyderabad-500004 |
Approved |
| IEC, Netaji Subhash Chandra Bose Cancer Research Institute, 16A Park Lane, Kolkata-700016 |
Approved |
| IEC, Patel Hospital Pvt. Ltd.Civil Lines Jalandhar |
Approved |
| IEC, Postgraduate Institute of Medical Education and research, Chandigarh-160012. |
Approved |
| IEC, R.S.T.Regional Cancer Centre, Manewada Road, Nagpur-440027 |
Approved |
| IEC, Regional Cancer Centre, Indira Gandhi Institute of Medical Science, Sheikhpura, Patna- 800014 |
Approved |
| IEC,Acharya Tulsi Regional Cancer Treatment & Research Institute, Bikaner |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Cisplatin |
100mg/m2 IV over 1 hr after completion of Paclitaxel through separate IV line |
| Intervention |
Mycobacterium W+Cisplation+Paclitaxel |
Test arm will receive (Paclitaxel + Cisplatin) by intravenous infusion on day 1 of a 21 days cycle. Mw will be given intradermally 0.2 ml at least one week prior to only first cycle of chemotherapy & 0.1 ml Mw in every second and third week of the all cycles of chemotherapy. 0.1 ml Mw injection will be given monthly after completion of all cycles of chemotherapy till 12 months from the start of the treatment or patient?s death, whichever is earlier |
| Comparator Agent |
Paclitaxel |
175mg/m2 IV over 3 hrs before
Cisplatin
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.INFORMED CONSENT OBTAINED & SIGNED:
o Ability to understand and the willingness to sign a written informed consent document.
2.DISEASE CHARACTERISTICS:
o Histologically or cytologically confirmed Non-Small Cell Lung Cancer, Stage IIIB or IV
3.PATIENT CHARACTERISTICS:
o Age:
-18 completed years and above
o Performance status
-ECOG 0-1
o Life expectancy
-At least 24 weeks
o Hematopoietic
-Absolute neutrophil count ≥ 1,500/mm3
-Platelet count ≥ 1,00,000/mm3
-Hemoglobin ≥ 9.0 g/dL
o Hepatic
-AST and ALT ≤ 2.5 times upper limit of normal (ULN) range of institution (5 times ULN if liver metastasis present).
-Bilirubin not greater than 1.5 times ULN range of institution (3 times ULN if liver involvement).
o Renal
- Serum Creatinine less than 1.5 times upper limit of normal (ULN) range of Institutional Lab Range.
4. Negative Pregnancy test for women of child bearing potential prior to entry into the trial.
|
|
| ExclusionCriteria |
| Details |
1. Patients who have had cytotoxic chemotherapy or radiotherapy prior to entering the study.
2. Patients with symptomatic brain metastasis
3. History of allergic reactions attributed to paclitaxel, cisplatin or mycobacteria or any of their ingredients.
4. Pregnant women or nursing women
5. Uncontrolled intercurrent illness that would limit compliance with study requirements.
6. HIV positive patients
7. Previous splenectomy |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. To determine & compare the overall survival time of patients in the two arms.
2. To determine & compare the effect of this treatment on Quality of life in the two arms.
|
After study completion |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. To determine & compare the Response rate in the two arms.
2. To study & compare the (hematological) toxicity in the two arms.
|
After study completion |
|
Target Sample Size
Modification(s)
|
Total Sample Size="221"
Sample Size from India="221"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
11/12/2008 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Study has completed and final report has been submitted to concerned agencies. |