ClinicalTrials.Veeva

Menu

Safety Study of Rapamycin Administered Before and During Radiotherapy to Treat Rectum Cancer

M

Maastricht Radiation Oncology

Status and phase

Completed
Phase 2
Phase 1

Conditions

Rectum Cancer

Treatments

Drug: Rapamycin

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

44 participants in 1 patient group

Rapamycine
Experimental group
Description:
rapamycine 6 mg dd
Treatment:
Drug: Rapamycin

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems