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

NCT00409994 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-03-18

No results posted yet for this study

Summary

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

  • Rectum Cancer

Interventions

DRUG

Rapamycin

dosis escalation: 2/4/6 mg rapamycin tablets, once daily during 13 days

Sponsors & Collaborators

  • Academisch Ziekenhuis Maastricht

    collaborator OTHER

  • Maastricht Radiation Oncology

    lead OTHER

Principal Investigators

  • Jeroen Buijsen, MD PhD · Maastricht Radiation Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2018-08-03
Completion
2018-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00409994 on ClinicalTrials.gov