NCT00002804

Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Children With Advanced Soft Tissue Sarcoma

Phase II Study of Neoadjuvant Vincristine, Ifosfamide, Doxorubicin, and AND G-CSF in Children With Advanced Stage Non-Rhabdomyosarcoma Soft Tissue Sarcomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, surgery, and radiation therapy in treating children who have advanced soft tissue sarcoma.

Detailed description

OBJECTIVES: I. Assess the response to vincristine/ifosfamide/doxorubicin (VID) with granulocyte colony-stimulating factor support in children with newly diagnosed, inoperable or metastatic non-rhabdomyosarcoma soft tissue sarcomas. II. Estimate the 2-year and event-free survival rates in children treated with VID plus radiotherapy and/or surgery. III. Establish a bank of frozen tumor and peripheral blood tissue for use in further molecular studies. OUTLINE: The following acronyms are used: DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 IFF Ifosfamide, NSC-109724 Mesna Mercaptoethane sulfonate, NSC-113891 VCR Vincristine, NSC-67574 VID VCR/IFF/DOX Induction: 3-Drug Combination Chemotherapy. VID. Local Control: Surgery and/or Radiotherapy plus 3-Drug Combination Chemotherapy. Excision of the primary tumor and pulmonary metastases; and/or irradiation of the primary tumor and pulmonary metastases using x-rays or Co60 beam energies of at least 4 MV (electrons or iridium-192 implant allowed for boost); plus VID. Continuation: 3-Drug Combination Chemotherapy. VID. PROJECTED ACCRUAL: A total of 40 patients will be entered over 2.7 years if there are at least 7 responses in the first 20 patients.

Conditions

• Sarcoma

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	doxorubicin hydrochloride
DRUG	ifosfamide
DRUG	mesna
DRUG	vincristine sulfate
PROCEDURE	conventional surgery
RADIATION	brachytherapy
RADIATION	low-LET cobalt-60 gamma ray therapy
RADIATION	low-LET electron therapy
RADIATION	low-LET photon therapy

Timeline

• Start date: 1996-09-01
• Primary completion: 2000-06-01
• Completion: 2006-04-01
• First posted: 2004-07-01
• Last updated: 2014-07-25

Locations

9 sites across 3 countries: United States, Puerto Rico, Switzerland