A Clinical Trial Testing Rapamycin, an mTOR-inhibitor, in Combination With Preoperative Radiotherapy in Operable Rectum Cancer: a Phase I and II Study
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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: Incidence of severe postoperative complications (grade IV or grade V),
within the first 6 weeks after surgery
Maastricht Radiation Oncology
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)