Clinical Outcomes and Treatment Compliance in Osteosarcoma Cases Treated With Low Cost Protocol in a Tertiary Care Cancer Center in India.

Not yet recruiting

• Conditions: Malignant neoplasm of bone and articular cartilage, unspecified,

• Registration Number: CTRI/2023/10/059247
• Lead Sponsor: Tata Memorial Centre

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-11
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 543

Inclusion Criteria

Histologically confirmed diagnosis of osteosarcoma Age more than and equal to 15 years Extremity location Treatment naïve.

Exclusion Criteria

Prior inadvertent treatment Non-osteosarcoma histology Non-extremity osteosarcomas.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	from 01/01/2017 to 31/01/2021
To evaluate fertility outcomes, long-term complications, and occupational rehabilitation among treated patients according to the following:	from 01/01/2017 to 31/01/2021
1. Age at menarche	from 01/01/2017 to 31/01/2021
2. Resumption of menarche	from 01/01/2017 to 31/01/2021
3. Semen/oocyte cryopreservation	from 01/01/2017 to 31/01/2021
4. Marriage	from 01/01/2017 to 31/01/2021
5. Live births	from 01/01/2017 to 31/01/2021
6. Long-term complications	from 01/01/2017 to 31/01/2021
7. Schooling	from 01/01/2017 to 31/01/2021
8. Jobs	from 01/01/2017 to 31/01/2021

Secondary Outcome Measures

Name	Time	Method
1) To evaluate the prognostic impact (in terms of EFS, OS) according to:	a.Histological response

Trial Locations

Locations (1)

Tata Memorial Center; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Center

🇮🇳Mumbai, MAHARASHTRA, India

Dr Jyoti Bajpai

Principal investigator

9920640040

drjyotibajpai25@gmail.com