| CTRI Number |
CTRI/2014/11/005227 [Registered on: 28/11/2014] Trial Registered Prospectively |
| Last Modified On: |
27/11/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
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Type of Study
|
Follow Up Study |
| Study Design |
Other |
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Public Title of Study
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A study of thromboembolic events in patients of advanced stage lung cancer treated with platinum based chemotherapy. |
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Scientific Title of Study
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Prospective observational study of thromboembolic events in patients of advanced stage Non small cell lung cancer(NSCLC) treated with platinum based chemotherapy. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Joshi |
| Designation |
Associate Professor and Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata memorial hospital
Dr. E. Borges Marg,
Parel, Mumbai – 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177032 |
| Fax |
|
| Email |
dramit74@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti kate |
| Designation |
Senior resident |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata memorial hospital
Dr. E. Borges Marg,
Parel, Mumbai – 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7506117343 |
| Fax |
|
| Email |
drshruti_kate@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Joshi |
| Designation |
Associate Professor and Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata memorial hospital
Dr. E. Borges Marg,
Parel, Mumbai – 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177032 |
| Fax |
|
| Email |
dramit74@yahoo.com |
|
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Source of Monetary or Material Support
|
| Tata Memorial Hospital
Dr. E. Borges Marg,
Parel, Mumbai – 400012
|
|
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Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital
Dr. E. Borges Marg,
Parel, Mumbai – 400012
|
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amit Joshi |
Tata Memorial Hospital |
Department of Medical Oncology , Uro-Oncology OPD,Room No 225 ,Homi Bhabha Block , Tata Memorial Hospital
Dr. E. Borges Marg,
Parel, Mumbai – 400012
Mumbai
MAHARASHTRA |
022-24177032
dramit74@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committees (IEC) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Advanced stage non small cell lung cancer (NSCLC) patients treated with platinum based chemotherapy., |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
Lung cancer patients (age >18 years) who are started on platinum based chemotherapy.
|
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| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
1. Age <18 years
2. Patients in whom therapy is discontinued prior to completion of 6 weeks due to any reason.
3. Presence of any thromboembolic event before start of chemotherapy including deep venous thrombosis (DVT), pulmonary embolus, cerebrovascular accident, and unstable angina/myocardial infarction (MI).
4.Patients with bleeding diathesis, inherited coagulopathy, and those requiring therapeutic anticoagulation, regular nonsteroidal anti-inflammatory drugs, and aspirin.
5. Patients receiving angiogenesis inhibitor drug- bevacizumab.
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OUTCOME:
The overall incidence, timing, and characteristics of thromboembolic events (venous or arterial) in adult patients of advanced stage non small cell lung cancer treated with platinum-based chemotherapy.
|
At the baseline and end of the study(4 weeks from the last dose of chemotherapy) or earlier in case of development of a thromboembolic event . |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
SECONDARY OUTCOME:
Secondary objectives are to analyze the prognostic value of baseline and treatment characteristics in predicting the occurrence of a thromboembolic events in patients of advanced stage non small cell lung cancer treated with platinum-based chemotherapy.
|
At the baseline and end of the study(4 weeks from the last dose of chemotherapy) or earlier in case of development of a thromboembolic event .
|
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Target Sample Size
|
Total Sample Size="167"
Sample Size from India="167"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
Aims/ Objectives of the study: 1. To determine the incidence of thromboembolic events including deep venous thrombosis (DVT), pulmonary embolus (PE), cerebrovascular accident, and unstable angina/myocardial infarction (MI) in patients of lung cancer treated with platinum-based chemotherapy. 2. To analyze the prognostic value of patients’ baseline and treatment characteristics in predicting occurrence of thromboembolic events in patients of lung cancer on platinum based chemotherapy.
Study methodology: 1.All patients will be evaluated at the baseline prior to start of chemotherapy by taking a detailed history and detailed physical examination. 2.Baseline characteristics of the patients will be noted including sex, BMI ,performance status , hemoglobin, total leucocyte count, platelet count and will be assigned to Khorana risk group (low , intermediate or high). Factors for univariate analysis will be these: 1. BMI ,Smoking ,DM , HTN ,Dyslipidemia ,Baseline hemoglobin, Baseline leucocyte count, Baseline platelet count, Presence of Central venous catheter, Khorana risk score. 3. All patients will be enquired for development of any thromboembolic event including at every visit with relevant history pertaining to deep venous thrombosis (DVT), pulmonary embolus (PE), cerebrovascular accident, and unstable angina/myocardial infarction (MI). 4. In the presence of a positive history relating to development of any thromboembolic event ,relevant diagnostic tests will be performed for confirmation of the diagnosis as per the treating physician’s decision. 5. A thromboembolic event will be considered associated with chemotherapy if it occurred between the time of the first dose of platinum based chemotherapy and 4 weeks after the last dose.
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