Response Based Treatment for Children With Unresectable Localized Soft Tissue Sarcoma

September 17, 2018 updated by: Samsung Medical Center

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Unresectable localized soft tissue sarcoma
  1. Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen.
  2. Surgery, if possible
  3. Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan)

  4. 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
Radiation: Radiotherapy
Drug: Cyclophosphamide
Drug: Cisplatin
Drug: Doxorubicin
Drug: Carboplatin
Drug: Melphalan
Drug: Ifosfamide
Drug: Etoposide
Drug: Thiotepa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of event free survival
Time Frame: Up to 3 years
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of adverse events
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2020

Study Completion (ANTICIPATED)

May 1, 2023

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (ESTIMATE)

May 26, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-07-115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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