Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00515931
Status:
COMPLETED
Last Update Posted:
2014-10-07
First Post:
2007-08-13
Brief Title:
Radiation Therapy as Palliative Treatment of GIST
Sponsor:
Heikki Joensuu
Organization:
University of Helsinki
Study Overview
Official Title:
Radiation Therapy as Palliative Treatment of GIST Progressing During or After Tyrosine Kinase Inhibitor Therapy A Prospective Study
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
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:
GIST-RT
Brief Summary:
Gastrointestinal stromal tumors GISTs are generally considered resistant to radiation but no prospective trials addressing efficacy and tolerability of radiation therapy have been carried out Limited clinical experience suggests that selected GIST patients may benefit from palliative radiation therapy The purpose of this prospective non-randomized multicenter study is to evaluate efficacy and safety of palliative radiation therapy in GIST patients who have progressive GIST during or after tyrosine kinase inhibitor therapy
Detailed Description:
Radiation therapy planning must be based on computerized tomography CT External beam radiation must be used Both 3D and IMRT plans are acceptable The cumulative radiation dose may range from 30 to 40 Gy as administered in 18 to 20 Gy fractions 5 fractions per week The dose is specified as defined by the ICRU International Commission on Radiation Units and Measurements report 50 Response is evaluated using CT 6 and 12 weeks after irradiation Adverse effects are evaluated using the Common Terminology Criteria for Adverse Effects CTCAEversion 3
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