Ignite Creation Date:
2024-05-06 @ 8:45 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02812654
Status:
UNKNOWN
Last Update Posted:
2016-06-24
First Post:
2016-03-24
Brief Title:
Ifosfamide Doxorubicin and Hypofractionated Radiotherapy in Neoadjuvant Sarcoma Treatment
Sponsor:
AC Camargo Cancer Center
Organization:
AC Camargo Cancer Center
Study Overview
Official Title:
The Use of Ifosfamide Doxorubicin and Hypofractionated Radiotherapy in Neoadjuvant Treatment of High-grade Extremity Soft Tissue and Non-metastatic Sarcomas
Status:
UNKNOWN
Status Verified Date:
2016-03
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:
Prospective phase II study Patients will be submitted to neoadjuvant chemotherapy cT and hypo fractionated radiotherapy hRT following by surgery The remain viable cells will be analyzed and the patients whithin less than 30 will receive more 3 cycles of cT All patients have deep high grade soft tissue sarcoma of extremity
Detailed Description:
Prospective phase II non controlled study Staging All patients will be submitted to a local Magnetic Resonance MR Chest Tomography CT and Positron emission tomography-computed tomography PET CT previous to treatment After the first cT cycle a new PET CT will be provided and one more at the end of the neoadjuvant treatment Chemotherapy cT neoadjuvant Doxorubicin 75mgm2 cycles 12 and 3 and ifosfamide 9 gm2 cycles 1 and 3 Radiotherapy RT 25 Gy 5 x 500 cGyday beginning at Cycle 2Day1 The surgery will be performed after 4-6 weeks from cycle 3 The remain of viable cells in surgical specimen will be analyzed and whether the the percentage value is less than 30 the patient will receive more 3 cycles of cT A boost of RT is indicated if margins are considered R1 microscopic positive margin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None