Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116935
Status:
COMPLETED
Last Update Posted:
2011-12-30
First Post:
2005-06-30
Brief Title:
Study Comparing 12 Months Versus 36 Months of Imatinib in the Treatment of Gastrointestinal Stromal Tumor GIST
Sponsor:
Scandinavian Sarcoma Group
Organization:
Scandinavian Sarcoma Group
Study Overview
Official Title:
Short 12 Months Versus Long 36 Months Duration of Adjuvant Treatment With the Tyrosine Kinase Inhibitor Imatinib Mesylate of Operable GIST With a High Risk of Recurrence
Status:
COMPLETED
Status Verified Date:
2011-12
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:
None
Brief Summary:
In this study patients who have been diagnosed with gastrointestinal stromal tumor GIST will be randomly allocated in a 11 ratio to receive imatinib Gleevec either for 12 or for 36 months following surgery The study participants are required to have a histologically verified GIST with a high risk of GIST recurrence despite complete removal of all macroscopic GIST tissue at surgery The highvery high risk of recurrence is defined as one of the following 1 the largest tumor diameter is over 10 cm 2 the mitosis count is high over 10 mitoses per 50 high power microscope fields HPFs 3 the largest tumor diameter over 5 cm and the mitosis count is over 550 HPFs 4 tumor spillage has taken place into the abdominal cavity at the time of surgery or following spontaneous tumor rupture All study participants will receive imatinib 400 mgday orally but the duration of imatinib administration will be determined randomly either for 12 or for 36 months The study participants will be followed up using blood tests and computed tomography or MRI of the abdomen The computed tomography examinations will be performed at 6 month intervals for a median of 5 years A total of 280 patients will be entered into the study The study hypothesis is that adjuvant imatinib may prevent some of the GIST recurrences and that there may be a difference in the rate of GIST recurrence between the two groups
Detailed Description:
This is an open-label randomized prospective phase III multicenter study carried out in the Nordic countries and in Germany Following macroscopically complete surgery the study participants will be allocated to receive imatinib either for 12 or for 36 months At randomization the patients are stratified into 2 strata 1 local disease 1 GIST tumor 2 intra-abdominal implants or resectable intra-abdominalhepatic metastases or intra-abdominal spillage is present or R1 surgery has been carried out microscopic disease has been left behind The imatinib dose is 400 mgday administered with food Imatinib dose adjustments are made as per protocol
Medical history current medication weight height and ECOG performance status are recorded prior to study entry Physical examination blood cell counts blood biochemistry pregnancy test chest X-ray or CT and CT or MRI of the abdomen and pelvis are carried outmeasured prior to study entry FDG-PET is an optional staging examination Research serum samples are collected for banking prior to initiating imatinib and at 6-month intervals during the study Tumor tissue is reviewed centrally to confirm the histological diagnosis of GIST and KIT and PDGFRA gene mutation analyses will be performed from stored GIST tissue
The study participants are monitored during adjuvant treatment and following adjuvant treatment Physical examination weight and ECOG performance status are assessed at 4- to 26-week intervals Adverse events are collected using structured forms at the times of the evaluation visits Blood cell counts and blood biochemistry are measured at 2- to 6-week intervals during imatinib therapy and at 6-month intervals following completion of adjuvant therapy CT or MRI examinations of the abdomen and pelvis are performed at 6-month intervals during the study
Medical history current medication weight height and ECOG performance status are recorded prior to study entry Physical examination blood cell counts blood biochemistry pregnancy test chest X-ray or CT and CT or MRI of the abdomen and pelvis are carried outmeasured prior to study entry FDG-PET is an optional staging examination Research serum samples are collected for banking prior to initiating imatinib and at 6-month intervals during the study Tumor tissue is reviewed centrally to confirm the histological diagnosis of GIST and KIT and PDGFRA gene mutation analyses will be performed from stored GIST tissue
The study participants are monitored during adjuvant treatment and following adjuvant treatment Physical examination weight and ECOG performance status are assessed at 4- to 26-week intervals Adverse events are collected using structured forms at the times of the evaluation visits Blood cell counts and blood biochemistry are measured at 2- to 6-week intervals during imatinib therapy and at 6-month intervals following completion of adjuvant therapy CT or MRI examinations of the abdomen and pelvis are performed at 6-month intervals during the study
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