Response Based Treatment for Children With Unresectable Localized Soft Tissue Sarcoma

NCT ID: NCT02784015

Last Updated: 2018-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2023-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Unresectable Localized Soft Tissue Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Doxorubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Ifosfamide

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Radiotherapy

Intervention Type RADIATION

Thiotepa

Intervention Type DRUG

Melphalan

Intervention Type DRUG

Interventions

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Cisplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Doxorubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Ifosfamide

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Radiotherapy

Intervention Type RADIATION

Thiotepa

Intervention Type DRUG

Melphalan

Intervention Type DRUG

Eligibility Criteria

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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)
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ki Woong Sung, MD, PhD

Role: CONTACT

82-2-3410-3529

Facility Contacts

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Ki Woong Sung

Role: primary

82-2-3410-3529

Other Identifiers

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2015-07-115

Identifier Type: -

Identifier Source: org_study_id

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