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
|
|
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
|
|
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 |