NCT00020566|UnknownPhase 3

Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma

European Ewing Tumour Working Initiative of National Groups Ewing Tumour Studies 1999 (EURO-E.W.I.N.G.99)

University of Leicester ClinicalTrials.gov

11 other identifiers

CDR0000068608EURO-EWING-INTERGROUP-EE99EBMT-INTERGROUP-EE99EORTC-62981GPOH-AUSTRIA-INTERGROUP-EE99GPOH-GERMANY-INTERGROUP-EE99SFOP-INTERGROUP-EE99SWS-SAKK-INTERGROUP-EE99CCLG-INTERGROUP-EE99COG-AEWS0331EU-20213

Study Type

interventional

Target

1,200

Locations

5 countries

Sites

103

Timeline

RegisteredJan 2003

StartedFeb 2001

Brief 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. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy and/or surgery in treating Ewing's sarcoma. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work when given with or without peripheral stem cell transplantation, radiation therapy, and/or surgery in treating patients with Ewing's sarcoma.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,200

participants targeted

Target at P75+ for phase_3

Geographic Reach

5 countries

103 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed

1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed

Last Updated

June 24, 2014

Status Verified

June 1, 2012

Enrollment Period

10.8 years

First QC Date

July 11, 2001

Last Update Submit

June 23, 2014

Conditions

Sarcoma

Keywords

localized Ewing sarcoma/peripheral primitive neuroectodermal tumormetastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor

Outcome Measures

Primary Outcomes (2)

Event-free survival
Overall survival

Secondary Outcomes (2)

Feasibility, toxicity, and response at 1 month following induction therapy
Feasibility and toxicity of consolidation regimens at 1 month following consolidation therapy

Study Arms (3)

Group 1

EXPERIMENTAL

Patients receive 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Patients requiring radiotherapy to the axial tumor also undergo concurrent radiotherapy 5 days a week. Some patients may then undergo surgical resection of the tumor. All patients will then receive vincristine IV on day 1 and dactinomycin IV and ifosfamide IV over 3 hours on days 1 and 2 (VAI). Treatment repeats every 21 days for 8 courses (courses 7-14). Patients requiring radiotherapy to the brain and/or spinal cord also undergo concurrent radiotherapy.

Biological: dactinomycinDrug: doxorubicin hydrochlorideDrug: etoposideDrug: ifosfamideDrug: vincristine sulfateProcedure: conventional surgeryRadiation: radiation therapy

Group 2, arm I

EXPERIMENTAL

Patients undergo 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Some patients may then undergo surgical resection of the tumor. All patients receive VAI chemotherapy as in group 1 for 1 course. Patients then receive 7 additional courses of VAI chemotherapy (courses 8-14). Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent whole-lung radiotherapy for 6-12 days.

Biological: dactinomycinDrug: doxorubicin hydrochlorideDrug: etoposideDrug: ifosfamideDrug: vincristine sulfateProcedure: conventional surgeryRadiation: radiation therapy

Group 2, arm II

EXPERIMENTAL

Patients undergo 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Some patients may then undergo surgical resection of the tumor. All patients receive VAI chemotherapy as in group 1 for 1 course. Patients then receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -6 to -3 and melphalan IV over 30 minutes on day -2. Patients receive autologous PBSC IV on day 0. Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent radiotherapy 5 days a week for at least 5 weeks.

Biological: dactinomycinDrug: busulfanDrug: doxorubicin hydrochlorideDrug: etoposideDrug: ifosfamideDrug: melphalanDrug: vincristine sulfateProcedure: autologous hematopoietic stem cell transplantationProcedure: conventional surgeryRadiation: radiation therapy