Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409994
Status:
COMPLETED
Last Update Posted:
2019-03-18
First Post:
2006-12-11
Brief Title:
Safety Study of Rapamycin Administered Before and During Radiotherapy to Treat Rectum Cancer
Sponsor:
Maastricht Radiation Oncology
Organization:
Maastricht Radiation Oncology
Study Overview
Official Title:
A Clinical Trial Testing Rapamycin an mTOR-inhibitor in Combination With Preoperative Radiotherapy in Operable Rectum Cancer a Phase I and Phase II Study
Status:
COMPLETED
Status Verified Date:
2019-03
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:
Investigating the safety and the activity of Rapamycin administered before and during preoperative radiotherapy in patients with an operable colorectal carcinoma The phase I dose escalation study will be performed in three steps 2 4 and 6 mg Patients entered in phase II will follow the same tolerable treatment regimen as patients in phase I study
Detailed Description:
Treatment regimen Phase I A daily dose of Rapamycin will be taken during 13 days At step 1 a dose of 2 mg will be given once a day at step 2 a dose of 4 mg will be given once a day at step 3 a dose of 6 mg will be given once a day
Preoperative radiotherapy 5x 5 Gy will be administered at day 8-12 followed by TME-surgery at day 15
Phase II A daily dose of 6 mg Rapamycin will be taken for 14 days unless the optimal dose found in the phase I study is lower
Preoperative radiotherapy 5x 5 Gy will be administered at day 9-15 followed by TME-surgery 7-8 weeks post RT
Sample size Phase I dose-escalation study Minimum 3 eligible patients per step maximum 6 eligible patients per step Phase II A total of 47 patients will be entered in this part of the study
Preoperative radiotherapy 5x 5 Gy will be administered at day 8-12 followed by TME-surgery at day 15
Phase II A daily dose of 6 mg Rapamycin will be taken for 14 days unless the optimal dose found in the phase I study is lower
Preoperative radiotherapy 5x 5 Gy will be administered at day 9-15 followed by TME-surgery 7-8 weeks post RT
Sample size Phase I dose-escalation study Minimum 3 eligible patients per step maximum 6 eligible patients per step Phase II A total of 47 patients will be entered in this part of 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