Response Based Treatment for Children With Unresectable Localized Soft Tissue Sarcoma

NCT02784015 | Unknown Phase 2

• 1 other identifier: 2015-07-115
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Unresectable Localized Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Rate of event free survival

  Up to 3 years

Secondary Outcomes (1)

• Rate of adverse events

  Up to 3 years

Study Arms (1)

Unresectable localized soft tissue sarcoma

EXPERIMENTAL

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

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

Interventions

Cisplatin DRUG

Unresectable localized soft tissue sarcoma

Etoposide DRUG

Unresectable localized soft tissue sarcoma

Doxorubicin DRUG

Unresectable localized soft tissue sarcoma

Cyclophosphamide DRUG

Unresectable localized soft tissue sarcoma

Ifosfamide DRUG

Unresectable localized soft tissue sarcoma

Carboplatin DRUG

Unresectable localized soft tissue sarcoma

Radiotherapy RADIATION

Unresectable localized soft tissue sarcoma

Thiotepa DRUG

Unresectable localized soft tissue sarcoma

Melphalan DRUG

Unresectable localized soft tissue sarcoma

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with unresectable localized high grade soft tissue sarcoma

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Cisplatin; Etoposide; Doxorubicin; Cyclophosphamide; Ifosfamide; Carboplatin; Radiotherapy; Thiotepa; Melphalan

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Therapeutics; Triethylenephosphoramide; Aziridines; Azirines; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Ki Woong Sung, MD, PhD

CONTACT

82-2-3410-3529; kiwoong.sung@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: May 26, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2023
• Last Updated: September 18, 2018

Record last verified: 2018-09

Locations

KR (1)