Response Based Treatment for Children With Unresectable Localized Soft Tissue Sarcoma

Samsung Medical Center

Status and phase

Unknown

Phase 2

Conditions

Unresectable Localized Soft Tissue Sarcoma

Treatments

Radiation: Radiotherapy

Drug: Melphalan

Drug: Carboplatin

Drug: Cyclophosphamide

Drug: Thiotepa

Drug: Doxorubicin

Drug: Etoposide

Drug: Cisplatin

Drug: Ifosfamide

Study type

Interventional

Funder types

Other

Identifiers

NCT02784015

2015-07-115

Details and patient eligibility

About

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

Full 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.

Enrollment

41 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

41 participants in 1 patient group

Unresectable localized soft tissue sarcoma

Experimental group

Description:

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

Treatment: