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CTRI Number  CTRI/2023/10/059247 [Registered on: 30/10/2023] Trial Registered Prospectively
Last Modified On: 20/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Retrospective Observational study 
Study Design  Other 
Public Title of Study   Clinical Outcomes and Treatment Compliance in Osteosarcoma Cases Treated With Low Cost Protocol in a Tertiary Care Cancer Center in India.  
Scientific Title of Study   Outcomes, Prognostic Factors and Treatment Compliance in Osteosarcoma Cases Treated with indigenous low-cost protocol OGS-12 in a Tertiary Care Cancer Centre in India.  
Trial Acronym  OGS-12 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jyoti Bajpai 
Designation  Professor of Medical Oncology Department  
Affiliation  Tata Memorial Centre Mumbai  
Address  Tata Memorial Centre, Dr. Ernest Borges Road, Parel, Mumbai Mumbai MAHARASHTRA India

Mumbai
MAHARASHTRA
400012
India 
Phone  9920640040  
Fax    
Email  drjyotibajpai25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyoti Bajpai 
Designation  Professor of Medical Oncology Department  
Affiliation  Tata Memorial Centre Mumbai  
Address  Tata Memorial Centre, Dr. Ernest Borges Road, Parel, Mumbai Mumbai MAHARASHTRA India

Mumbai
MAHARASHTRA
400012
India 
Phone  9920640040  
Fax    
Email  drjyotibajpai25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Laboni Sarkar 
Designation  Senior Resident III of Medical Oncology Department  
Affiliation  Tata Memorial Centre Mumbai  
Address  Tata Memorial Centre, Dr. Ernest Borges Road, Parel, Mumbai Mumbai MAHARASHTRA India

Mumbai
MAHARASHTRA
400012
India 
Phone  9830567326  
Fax    
Email  drlabonisarkar@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
Tata Memorial Centre, Tata Memorial Hospital, Dr. E. Borges Road, Parel (E), Mumbai 400012 
 
Primary Sponsor  
Name  Tata Memorial Centre  
Address  Tata Memorial Centre,Tata Memorial Hospital, Dr Ernest Borges Road, Parel, Mumbai 400012. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jyoti Bajpai   Tata Memorial Center   Tata Memorial Hospital, Department of Medical Oncology, Main Building, Room no. 93, Dr Ernest Borges Rd, Parel East, Parel, Mumbai, Maharashtra 400012
Mumbai
MAHARASHTRA 
9920640040

drjyotibajpai25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C419||Malignant neoplasm of bone and articular cartilage, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Histologically confirmed diagnosis of osteosarcoma
Age more than and equal to 15 years
Extremity location
Treatment naïve 
 
ExclusionCriteria 
Details  Prior inadvertent treatment
Non-osteosarcoma histology
Non-extremity osteosarcomas
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the survival following treatment with surgery and OGS-12 chemotherapy protocol in newly diagnosed, treatment naïve, extremity osteosarcoma patients. The following survival endpoints will be considered: event-free survival (DFS, as the primary endpoint), and overall survival (OS, as the secondary endpoint).
To evaluate fertility outcomes, long-term complications, and occupational rehabilitation among treated patients according to the following:
1. Age at menarche
2. Resumption of menarche
3. Semen/oocyte cryopreservation
4. Marriage
5. Live births
6. Long-term complications
7. Schooling
8. Jobs

 
from 01/01/2017 to 31/01/2021 
 
Secondary Outcome  
Outcome  TimePoints 
1) To evaluate the prognostic impact (in terms of EFS, OS) according to:
a.Histological response
b.Baseline nutritional parameters (hemoglobin, serum alkaline phosphatase, albumin)
c.Treatment duration
2) To evaluate toxicities associated with OGS-12 chemotherapy protocol
3) To evaluate treatment compliance
a.Incidence of treatment abandonment
b.Reason for treatment abandonment
c.Time from 1st chemotherapy cycle to 8th chemotherapy cycle (dose intensity) 
from 01/01/2017 to 31/01/2021 
 
Target Sample Size   Total Sample Size="543"
Sample Size from India="543" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/11/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 A) Introduction:

 The purpose of this study is to understand toxicities, prognostic factors, outcomes, and survival rates for the chemotherapy protocol “OGS-12” used in our institute

 The study intends to explore the safety and efficacy of this chemotherapy protocol and additional concerns relevant to adolescents and young adults in whom this tumor is most common, such as fertility and social implications among survivors

 

 B) Diagnosis, type of cancer

 i) Osteosarcoma is the most common bone tumor in children and young adolescents.

 ii) It is aggressive but sensitive to chemotherapy.

iii) The patients in this study have localized diseases that had not spread to other sites at diagnosis. They have been treated with surgery and chemotherapy to reduce the chance of disease relapse. 

 

C) Options for investigating, diagnosing, and treating this disease:

i) Osteosarcoma is generally diagnosed using physical examination of the tumor site, radiological tests (magnetic resonance imaging and computed tomography (MRI, CT chest), tissue biopsy (removing tumor cells for testing of cancer), and blood tests.

 ii) The following treatment options are available for your type of breast cancer, Treatment available for your type of cancer: o Standard treatment consists of surgery to remove the tumor (local therapy) and chemotherapy (systemic therapy) to prevent the chances of disease relapse and radiation therapy in some cases (high-powered radiation energy to kill cancer cells). 

 

D) Possible risks and benefits with the available and proposed treatments:

i) Treatment available for your type of cancer: Standard treatment consists of surgery to remove the tumor (local therapy) and chemotherapy (systemic therapy) to prevent the chances of disease relapse.

ii) Treatment proposed in this study Patients are treated with the standard institutional protocol consisting of surgery to remove the tumor (local therapy) and chemotherapy (systemic therapy) to prevent the chances of disease relapse

 

E) Where and how the treatment and follow-up  will be done:

 i) Treatment: The treatment is done at Tata Memorial Hospital BST (Bone and Soft Tissue) OPD

 ii) Follow-up: The follow-up is done at Tata Memorial Hospital BST (Bone and Soft Tissue) OPD F) Time and costs involved 

iii) Time: Not applicable as the study details are being collected from electronic medical records

iv) Cost: Not applicable as the study details are being collected from electronic medical records

 
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