Overview

This trial is active, not recruiting.

Condition neuroendocrine tumors, net
Treatment lu-177 dota-tate
Sponsor AHS Cancer Control Alberta
Collaborator Cross Cancer Institute
Start date October 2012
End date August 2016
Trial size 69 participants
Trial identifier NCT01763554, REV-LUT-001

Summary

Review of the medical files of 69 patients with neuroendocrine tumours who were treated at the CCI from January/10 - July/12 with Lutetium-177 DOTA-TATE under Health Canada's Special Access Programme (SAP). Efficacy, safety, and other relevant data will be collected.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective

Primary Outcomes

Measure
Efficacy data on subjects with neuroendocrine tumours (NET) treated Lu-177 DOTA-TATE
time frame: Retrospective data January 2010 - July 2012

Secondary Outcomes

Measure
Safety and other relevant information on subjects treated with Lu-177 DOTA-TATE
time frame: Retrospective data January 2010 - July 2012

Eligibility Criteria

Male or female participants from 14 years up to 90 years old.

Inclusion Criteria: - Male or female ≥ 14 - 90 years of age - Presence of histologically proven NET tumour(s) - Serum creatinine ≤ 150 µmol/L, and a measured GFR using plasma clearance of ≥50 mL/min - Haemoglobin concentration 5.5 mmol/L; WBC ≥ 2*109/L; platelets ≥ 100*109/L - Liver function tests (serum albumin, total bilirubin, ALT, AST and alkaline phosphatase) ≤ 3X the upper limit of normal Exclusion Criteria: - Potential for surgery with curative intent - Surgery, radiation therapy, cytotoxic chemotherapy, embolization or other investigative therapy (interferons, mTOR inhibitors) within 12 weeks of enrollment - Known brain metastases unless these metastases have been treated and stabilized (confirmed by CT) for ≥ 6 months prior to enrollment - Uncontrolled congestive heart failure - Receiving concomitant medications which decrease renal function - Uncontrolled diabetes mellitus - Pregnancy

Additional Information

Official title Review of Medical Records of Patients Who Have Been Treated With Lutetium at the Cross Cancer Institute Between January 2010 and July 31, 2012
Principal investigator Alexander McEwan, MD
Description Neuroendocrine tumours comprise a spectrum of rare neoplasms. Data analysis will be conducted to obtain efficacy, safety, and other relevant data from each Lu-177 DOTA-TATE treatment.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by AHS Cancer Control Alberta.