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临床试验/CTRI/2023/10/059247
CTRI/2023/10/059247尚未招募不适用

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.

Tata Memorial Centre1 个研究点 分布在 1 个国家目标入组 543 人开始时间: 2023年5月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
543
试验地点
1
主要终点
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).

研究概览

简要总结

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

研究设计

研究类型
Observational

入排标准

年龄范围
15.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

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

排除标准

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

结局指标

主要结局

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).

时间窗: 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:

时间窗: from 01/01/2017 to 31/01/2021

1. Age at menarche

时间窗: from 01/01/2017 to 31/01/2021

2. Resumption of menarche

时间窗: from 01/01/2017 to 31/01/2021

3. Semen/oocyte cryopreservation

时间窗: from 01/01/2017 to 31/01/2021

4. Marriage

时间窗: from 01/01/2017 to 31/01/2021

5. Live births

时间窗: from 01/01/2017 to 31/01/2021

6. Long-term complications

时间窗: from 01/01/2017 to 31/01/2021

7. Schooling

时间窗: from 01/01/2017 to 31/01/2021

8. Jobs

时间窗: from 01/01/2017 to 31/01/2021

次要结局

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

研究者

申办方类型
Research institution and hospital

研究点 (1)

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