Response Based Treatment for Children With Unresectable Localized Soft Tissue Sarcoma

Unresectable Localized Soft Tissue Sarcoma Clinical Trial

Official title:

Response-based Treatment for Children With Unresectable Localized Soft Tissue Sarcomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02784015
• Other study ID #: 2015-07-115
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2016
• Est. completion date: May 2023

Study information

• Verified date: September 2018
• Source: Samsung Medical Center
• Contact: Ki Woong Sung, MD, PhD
• Phone: 82-2-3410-3529
• Email: kiwoong.sung[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the treatment outcome of unresectable soft tissue sarcoma using response based treatment

Description:

Response after initial chemotherapy is one of the important prognostic factor in many cancers. In this study, treatment will be tailored according to the treatment responses which are assessed by tumor volume reduction, necrosis rate or residual fludeoxyglucose (FDG) uptake in positron emission tomography (PET) scan.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. completion date: May 2023
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Patients with unresectable localized high grade soft tissue sarcoma

Exclusion Criteria:

• Patients with organ dysfunction (ejection fraction, liver function test, creatinine > CTCAE grade 2)

Related Conditions & MeSH terms

• Sarcoma
• Unresectable Localized Soft Tissue Sarcoma

Intervention

Drug:
• Cisplatin

• Etoposide

• Doxorubicin

• Cyclophosphamide

• Ifosfamide

• Carboplatin

Radiation:
• Radiotherapy

Drug:
• Thiotepa

• Melphalan

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of event free survival		Up to 3 years
Secondary	Rate of adverse events		Up to 3 years