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Sponsors and Collaborators: |
Maastricht Radiation Oncology Academisch Ziekenhuis Maastricht |
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Information provided by: | Maastricht Radiation Oncology |
ClinicalTrials.gov Identifier: | NCT00409994 |
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.
Condition | Intervention | Phase |
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Rectum Cancer |
Drug: Rapamycin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Clinical Trial Testing Rapamycin, an mTOR-Inhibitor, in Combination With Preoperative Radiotherapy in Operable Rectum Cancer: a Phase I and II Study |
Estimated Enrollment: | 65 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
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 13 days (unless the optimal dose found in the phase I study is lower).
Preoperative radiotherapy (5x 5 Gy) will be administered at day 8-12, followed by TME-surgery at day 15.
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Philippe Lambin, Prof, MD PHD | +31 (0) 88 44 55 666 | philippe.lambin@maastro.nl |
Contact: Guido Lammering, MD PhD | =31 (0) 88 44 55 666 | guido.lammering@maastro.nl |
Netherlands, Limburg | |
Maastricht Radiation Oncology | Recruiting |
Maastricht, Limburg, Netherlands, 6202 AZ | |
Contact: Guido Lammering +31 (0) 88 44 55 666 guido.lammering@maastro.nl | |
Contact: Jos Jager +31 (0) 88 44 55 666 jos.jager@maastro.nl | |
Principal Investigator: Guido Lammering |
Principal Investigator: | Guido Lammering | Maastricht Radiation Oncology |
Responsible Party: | MAASTRO clinic ( prof.dr. Ph. Lambin ) |
Study ID Numbers: | 04-16 |
Study First Received: | December 11, 2006 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00409994 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Colorectal cancer M-tor inhibitor Rapamycin |
Sirolimus Digestive System Neoplasms Immunologic Factors Clotrimazole Rectal Neoplasms Gastrointestinal Diseases Miconazole Tioconazole Rectal Neoplasm Intestinal Diseases |
Immunosuppressive Agents Rectal Diseases Intestinal Neoplasms Anti-Bacterial Agents Digestive System Diseases Rectal Cancer Antifungal Agents Gastrointestinal Neoplasms Colorectal Neoplasms |
Sirolimus Anti-Infective Agents Digestive System Neoplasms Immunologic Factors Antineoplastic Agents Rectal Neoplasms Gastrointestinal Diseases Physiological Effects of Drugs Intestinal Diseases Antibiotics, Antineoplastic Immunosuppressive Agents |
Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Anti-Bacterial Agents Neoplasms Neoplasms by Site Digestive System Diseases Antifungal Agents Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms |