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Response Based Treatment for Children With Unresectable Localized Soft Tissue Sarcoma

Primary Purpose

Unresectable Localized Soft Tissue Sarcoma

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cisplatin
Etoposide
Doxorubicin
Cyclophosphamide
Ifosfamide
Carboplatin
Radiotherapy
Thiotepa
Melphalan
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable Localized Soft Tissue Sarcoma

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Unresectable localized soft tissue sarcoma

Arm Description

Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen. Surgery, if possible Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan) Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation, if there are still residual tumors after 9 cycle of chemotherapy, surgery, and radiotherapy. 1st HDCT: carboplatin, thiotepa, etoposide 2nd HDCT: cyclophosphamide, melphalan

Outcomes

Primary Outcome Measures

Rate of event free survival

Secondary Outcome Measures

Rate of adverse events

Full Information

First Posted
May 24, 2016
Last Updated
September 17, 2018
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02784015
Brief Title
Response Based Treatment for Children With Unresectable Localized Soft Tissue Sarcoma
Official Title
Response-based Treatment for Children With Unresectable Localized Soft Tissue Sarcomas
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the treatment outcome of unresectable soft tissue sarcoma using response based treatment
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Localized Soft Tissue Sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unresectable localized soft tissue sarcoma
Arm Type
Experimental
Arm Description
Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen. Surgery, if possible Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan) Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation, if there are still residual tumors after 9 cycle of chemotherapy, surgery, and radiotherapy. 1st HDCT: carboplatin, thiotepa, etoposide 2nd HDCT: cyclophosphamide, melphalan
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Type
Drug
Intervention Name(s)
Thiotepa
Intervention Type
Drug
Intervention Name(s)
Melphalan
Primary Outcome Measure Information:
Title
Rate of event free survival
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Rate of adverse events
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ki Woong Sung, MD, PhD
Phone
82-2-3410-3529
Email
kiwoong.sung@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Woong Sung
Phone
82-2-3410-3529
Email
kwsped@skku.edu
First Name & Middle Initial & Last Name & Degree
Ki Woong Sung

12. IPD Sharing Statement

Learn more about this trial

Response Based Treatment for Children With Unresectable Localized Soft Tissue Sarcoma

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