Safety Study of Rapamycin Administered Before and During Radiotherapy to Treat Rectum Cancer
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|ClinicalTrials.gov Identifier: NCT00409994|
Recruitment Status : Active, not recruiting
First Posted : December 12, 2006
Last Update Posted : March 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Rectum Cancer||Drug: Rapamycin||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2006|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2019|
rapamycine 6 mg dd
dosis escalation: 2/4/6 mg rapamycin tablets, once daily during 13 days
Other Name: Sirolimus
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409994
|Maastricht Radiation Oncology|
|Maastricht, Limburg, Netherlands, 6202 AZ|
|Principal Investigator:||Jeroen Buijsen, MD PhD||Maastricht Radiation Oncology|