Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334854
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2006-06-07
Brief Title:
Ifosfamide and Doxorubicin Radiation Therapy andor Surgery in Treating Young Patients With Localized Soft Tissue Sarcoma
Sponsor:
European Paediatric Soft Tissue Sarcoma Study Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas
Status:
UNKNOWN
Status Verified Date:
2009-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as ifosfamide and doxorubicin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Radiation therapy uses high-energy x-rays to kill tumor cells Giving combination chemotherapy with or without radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving radiation therapy after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase III trial is studying how well giving ifosfamide and doxorubicin radiation therapy andor surgery works in treating young patients with localized soft tissue sarcoma
PURPOSE This phase III trial is studying how well giving ifosfamide and doxorubicin radiation therapy andor surgery works in treating young patients with localized soft tissue sarcoma
Detailed Description:
OBJECTIVES
Primary
Determine survival rates event-free survival and overall survival OS and the pattern of treatment failure in patients with synovial sarcoma or adult-type soft tissue sarcoma treated with ifosfamide and doxorubicin hydrochloride radiotherapy andor surgery
Determine the role of ifosfamide and doxorubicin hydrochloride in improving the response rate in patients with unresectable synovial sarcoma or adult-type soft tissue sarcoma
Secondary
Evaluate clinicalpathological prognostic factors particularly tumor grade and radiological and pathological response to neoadjuvant treatment
Determine the impact of omitting adjuvant chemotherapy in patients with low-risk synovial sarcoma tumor 5 cm
Determine the role of adjuvant chemotherapy in improving the metastases-free survival and OS in patients with adult-type soft tissue sarcoma Intergroup Rhabdomyosarcoma Study IRS postsurgical grouping system I-II tumor grade 3 tumor size 5 cm
OUTLINE This is a nonrandomized prospective historically controlled multicenter study Patients with synovial sarcoma are stratified according to the Intergroup Rhabdomyosarcoma Study IRS postsurgical grouping system I vs II vs III and tumor size 5 cm vs 5 cm Patients with adult-type soft tissue sarcoma are stratified according to the IRS postsurgical grouping system I vs II vs III tumor size 5 cm vs 5 cm and tumor grade G1 vs G2 vs G3 Patients are assigned to 1 of 9 treatment groups according to disease and stratification
Synovial sarcoma
Group 1 IRS group I tumor 5 cm Patients undergo surgical resection of tumor
Group 2 IRS group I tumor 5 cm Patients receive ifosfamide IV over 3 hours on days 1-3 and doxorubicin hydrochloride IV over 4-6 hours on days 1 and 2 IFO-DOX Treatment repeats every 21 days for 4 courses
Group 3 IRS group II tumor 5 cm Patients receive 3 courses of IFO-DOX After the completion of chemotherapy patients undergo radiotherapy 5 days a week for 5-6 weeks
Group 4 IRS group II tumor 5 cm Patients receive 3 courses of IFO-DOX Patients then receive ifosfamide alone IV over 3 hours on days 1-3 Treatment with ifosfamide repeats every 21 days for 2 courses Patients also receive concurrent radiotherapy concurrently with ifosfamide 5 days a week for 5-6 weeks After completion of radiotherapy patients receive 1 additional course of IFO-DOX
Group 5 IRS group III N1 Patients receive 3 courses of IFO-DOX Patients with no response to chemotherapy receive 1 of the following local therapies
Delayed complete resection
Radiotherapy as in group 3 followed by surgery
Delayed complete resection followed by radiotherapy as in group 3
Delayed incomplete resection followed by radiotherapy as in group 3
Radiotherapy as in group 3 Patients with major or minor response to chemotherapy receive 2 courses of ifosfamide with concurrent radiotherapy followed by 1 additional course of IFO-DOX as in group 4 above
NOTE Patients undergo surgery 5 weeks after completion of chemotherapy andor radiotherapy
NOTE Patients undergo radiotherapy beginning 21 days after surgery
Adult-type soft tissue sarcoma
Group 1 IRS group I tumor 5 cm Patients undergo surgical resection of tumor
Group 2 IRS group I tumor 5 cm Patients receive therapy according to tumor grade
G1 disease Patients undergo surgical resection
G2 disease Patients undergo radiotherapy 5 days a week for 5-6 weeks
G3 disease Patients receive the following sequential treatment 3 courses of IFO-DOX followed by 2 courses of ifosfamide with concurrent radiotherapy followed by 1 course of IFO-DOX
Group 3 IRS group II N0 Patients receive therapy according to tumor grade
G1 disease Patients undergo surgical resection
G2-3 disease 5 cm and G2 disease 5 cm Patients undergo radiotherapy 5 days a week for 5-6 weeks
G3 disease 5 cm Patients undergo sequential treatment as in group 2 adult-type soft tissue sarcoma
Group 4 IRS group III N1 Patients receive 3 courses of IFO-DOX Patients with no response to chemotherapy receive local therapy as in group 5 synovial sarcoma Patients with major or minor response to chemotherapy receive 2 courses of ifosfamide with concurrent radiotherapy followed by 2 additional courses of IFO-DOX as in group 4 synovial sarcoma
After completion of study therapy patients are followed periodically for up to 10 years
PROJECTED ACCRUAL A total of 250 patients will be accrued for this study
Primary
Determine survival rates event-free survival and overall survival OS and the pattern of treatment failure in patients with synovial sarcoma or adult-type soft tissue sarcoma treated with ifosfamide and doxorubicin hydrochloride radiotherapy andor surgery
Determine the role of ifosfamide and doxorubicin hydrochloride in improving the response rate in patients with unresectable synovial sarcoma or adult-type soft tissue sarcoma
Secondary
Evaluate clinicalpathological prognostic factors particularly tumor grade and radiological and pathological response to neoadjuvant treatment
Determine the impact of omitting adjuvant chemotherapy in patients with low-risk synovial sarcoma tumor 5 cm
Determine the role of adjuvant chemotherapy in improving the metastases-free survival and OS in patients with adult-type soft tissue sarcoma Intergroup Rhabdomyosarcoma Study IRS postsurgical grouping system I-II tumor grade 3 tumor size 5 cm
OUTLINE This is a nonrandomized prospective historically controlled multicenter study Patients with synovial sarcoma are stratified according to the Intergroup Rhabdomyosarcoma Study IRS postsurgical grouping system I vs II vs III and tumor size 5 cm vs 5 cm Patients with adult-type soft tissue sarcoma are stratified according to the IRS postsurgical grouping system I vs II vs III tumor size 5 cm vs 5 cm and tumor grade G1 vs G2 vs G3 Patients are assigned to 1 of 9 treatment groups according to disease and stratification
Synovial sarcoma
Group 1 IRS group I tumor 5 cm Patients undergo surgical resection of tumor
Group 2 IRS group I tumor 5 cm Patients receive ifosfamide IV over 3 hours on days 1-3 and doxorubicin hydrochloride IV over 4-6 hours on days 1 and 2 IFO-DOX Treatment repeats every 21 days for 4 courses
Group 3 IRS group II tumor 5 cm Patients receive 3 courses of IFO-DOX After the completion of chemotherapy patients undergo radiotherapy 5 days a week for 5-6 weeks
Group 4 IRS group II tumor 5 cm Patients receive 3 courses of IFO-DOX Patients then receive ifosfamide alone IV over 3 hours on days 1-3 Treatment with ifosfamide repeats every 21 days for 2 courses Patients also receive concurrent radiotherapy concurrently with ifosfamide 5 days a week for 5-6 weeks After completion of radiotherapy patients receive 1 additional course of IFO-DOX
Group 5 IRS group III N1 Patients receive 3 courses of IFO-DOX Patients with no response to chemotherapy receive 1 of the following local therapies
Delayed complete resection
Radiotherapy as in group 3 followed by surgery
Delayed complete resection followed by radiotherapy as in group 3
Delayed incomplete resection followed by radiotherapy as in group 3
Radiotherapy as in group 3 Patients with major or minor response to chemotherapy receive 2 courses of ifosfamide with concurrent radiotherapy followed by 1 additional course of IFO-DOX as in group 4 above
NOTE Patients undergo surgery 5 weeks after completion of chemotherapy andor radiotherapy
NOTE Patients undergo radiotherapy beginning 21 days after surgery
Adult-type soft tissue sarcoma
Group 1 IRS group I tumor 5 cm Patients undergo surgical resection of tumor
Group 2 IRS group I tumor 5 cm Patients receive therapy according to tumor grade
G1 disease Patients undergo surgical resection
G2 disease Patients undergo radiotherapy 5 days a week for 5-6 weeks
G3 disease Patients receive the following sequential treatment 3 courses of IFO-DOX followed by 2 courses of ifosfamide with concurrent radiotherapy followed by 1 course of IFO-DOX
Group 3 IRS group II N0 Patients receive therapy according to tumor grade
G1 disease Patients undergo surgical resection
G2-3 disease 5 cm and G2 disease 5 cm Patients undergo radiotherapy 5 days a week for 5-6 weeks
G3 disease 5 cm Patients undergo sequential treatment as in group 2 adult-type soft tissue sarcoma
Group 4 IRS group III N1 Patients receive 3 courses of IFO-DOX Patients with no response to chemotherapy receive local therapy as in group 5 synovial sarcoma Patients with major or minor response to chemotherapy receive 2 courses of ifosfamide with concurrent radiotherapy followed by 2 additional courses of IFO-DOX as in group 4 synovial sarcoma
After completion of study therapy patients are followed periodically for up to 10 years
PROJECTED ACCRUAL A total of 250 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCLG-EpSSG-STS-2006-03 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000482277 | REGISTRY | None | None |
| EU-20620 | None | None | None |
| EUDRACT-2005-001139-31 | None | None | None |
| UKCCSG-CTA-2127502150010001 | None | None | None |