Safety Study of Rapamycin Administered Before and During Radiotherapy to Treat Rectum Cancer
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- Phase I: Incidence of severe postoperative complications (grade IV or grade V), [ Time Frame: within the first 6 weeks after surgery ]
- assessed according to CTCv3.0 [ Time Frame: within the first 6 weeks after surgery ]
- Phase II: Tumour blood flow assessed CT-PET + CTp [ Time Frame: day 64 ]
- Phase I:Incidence of other acute toxicity, assessed according to CTCv 3.0 [ Time Frame: within the first 6 weeks after surgery ]
- Activation status of mTor related and dependent molecules in the tumour [ Time Frame: within the first 6 weeks after surgery ]
- Phase II:Maximum standardised Uptake Value (SUV) of 18F-FDG, assessed bij PET-CT-scan [ Time Frame: day 64 ]
- Phase II:Incidence of acute side effects of rapamycin, assessed according to CTCv 4.0 [ Time Frame: day 8, 15, 22, 36, 50 and 64 ]
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||August 2019|
|Estimated Primary Completion Date:||August 2018 (Final data collection date for primary outcome measure)|
rapamycine 6 mg dd
dosis escalation: 2/4/6 mg rapamycin tablets, once daily during 13 days
Other Name: Sirolimus
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409994
|Maastricht Radiation Oncology|
|Maastricht, Limburg, Netherlands, 6202 AZ|
|Principal Investigator:||Jeroen Buijsen, MD PhD||Maastricht Radiation Oncology|