NCT00006734

Comparison of Combination Chemotherapy Regimens in Treating Patients With Ewing's Sarcoma or Neuroectodermal Tumor

Trial of Chemotherapy Intensification Through Compression in Ewing's Sarcoma and Related Tumors

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 587 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 0 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy work in 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. It is not yet known which chemotherapy regimen combined with radiation therapy and/or surgery is more effective in treating Ewing's sarcoma or primitive neuroectodermal tumor. PURPOSE: Randomized phase III trial to compare the effectiveness of different chemotherapy regimens combined with radiation therapy and/or surgery in treating patients who have Ewing's sarcoma or primitive neuroectodermal tumor.

Detailed description

OBJECTIVES: * Compare the effect of interval-compressed vs standard chemotherapy in terms of event-free survival and overall survival in patients with newly diagnosed, localized Ewing's sarcoma or peripheral primitive neuroectodermal tumor. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 18 years vs 18 years and over) and location of primary disease (pelvic vs nonpelvic). Patients are randomized to 1 of 2 treatment arms for induction and continuation therapy. * Induction therapy (weeks 1-12): * Arm I: Patients receive alternating courses of chemotherapy consisting of vincristine IV on day 1, doxorubicin IV continuously over 48 hours on days 1 and 2, and cyclophosphamide IV over 1 hour on day 1 for courses 1 and 3 and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 for courses 2 and 4. Beginning 24 hours after the last dose of chemotherapy for each course, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover. Treatment continues every 3 weeks for 4 courses. * Arm II: Patients receive alternating courses of chemotherapy consisting of vincristine, doxorubicin, and cyclophosphamide as in arm I for courses 1, 3, and 5 and ifosfamide and etoposide as in arm I for courses 2, 4, and 6. Patients also receive G-CSF as in arm I. Treatment continues every 2 weeks for 6 courses. After completion of induction therapy, patients in both arms receive local control treatment to the primary tumor. Patients receive continuation chemotherapy after surgery or concurrently with radiotherapy. * Continuation therapy: * Arm I (weeks 13-42): Patients receive additional alternating courses of chemotherapy as in arm I of induction therapy with the exception of vincristine and cyclophosphamide alone for courses 7 and/or 11 and/or 13. Patients also receive G-CSF as in induction therapy. Treatment continues every 3 weeks for 10 courses. * Arm II (weeks 13-29): Patients receive additional alternating courses of chemotherapy as in arm II of induction therapy with the exception of vincristine and cyclophosphamide alone for courses 9 and/or 11 and/or 13. Patients also receive G-CSF as in induction therapy. Treatment continues every 2 weeks for 8 courses. Patients are followed every 3 months for 4 years and then every 6 months for 1 year. PROJECTED ACCRUAL: Approximately 528 patients will be accrued for this study within 4-5 years.

Conditions

• Sarcoma

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	Given IV
DRUG	cyclophosphamide	Given IV
DRUG	doxorubicin hydrochloride	Given IV
DRUG	etoposide	Given IV
DRUG	ifosfamide	Given IV
DRUG	vincristine sulfate	Given IV
PROCEDURE	adjuvant therapy
PROCEDURE	conventional surgery
PROCEDURE	neoadjuvant therapy
RADIATION	brachytherapy
RADIATION	radiation therapy

Timeline

• Start date: 2001-05-01
• Primary completion: 2006-08-01
• Completion: 2023-06-30
• First posted: 2003-01-27
• Last updated: 2023-08-03

Locations

239 sites across 7 countries: United States, Australia, Canada, Netherlands, New Zealand, Puerto Rico, Switzerland