Clinical trial · Interventional
Safety Study of Rapamycin Administered Before and During Radiotherapy to Treat Rectum Cancer
A Clinical Trial Testing Rapamycin, an mTOR-inhibitor, in Combination With Preoperative Radiotherapy in Operable Rectum Cancer: a Phase I and Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectum Cancer | Rectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rapamycin | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rapamycine
- description
- rapamycine 6 mg dd
- interventionNames
- Drug: Rapamycin
Primary outcomes (3)
- measure
- Phase I: Incidence of severe postoperative complications (grade IV or grade V),
- timeFrame
- within the first 6 weeks after surgery
- measure
- assessed according to CTCv3.0
- timeFrame
- within the first 6 weeks after surgery
- measure
- Phase II: Tumour blood flow assessed CT-PET + CTp
- timeFrame
- day 64
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Histologically proven rectum cancer * UICC TNM I-III * WHO performance status 0-2 * Less than 10% weight loss the last 6 months * No recent (\< 3 months) severe cardiac disease * Normal serum bilirubin and serum creatinin Exclusion Criteria: * Concurrent chemotherapy with radiation * History of prior pelvis radiotherapy * Recent (\<3 months) myocardial infarction * Uncontrolled infectious disease * Concurrent medication known as inhibitors of CYP3A4 susceptible to increase Rapamycin blood concentrations
References
Publications (0)
Data not yet available