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32P BioSiliconTM in Addition to Gemcitabine in Pancreatic Cancer

NCT00346281 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2006-06-29

No results posted yet for this study

Summary

This is the first study investigating the safety of 32P BioSilicon in patients with advanced,unresectable pancreatic cancer who are also receiving standard intravenous gemcitabine chemotherapy. The secondary aims of the study will assess the implantation procedure, localisation of 32P BioSilicon, tumour response and survival parameters.

Tumours targetted with 32P BioSilicon is hypothesized to show a reduction in tumour volume and with the low radioactivity dose that is delivered intratumourally, the incidence of side effects associated with the treatment is expected to be low. Prologation of survival and improved quality of life could be favourable outcomes of the investigational product.

Conditions

Interventions

DEVICE

32P BioSilicon

Sponsors & Collaborators

  • pSiOncology Private Limited

    collaborator UNKNOWN

  • Singapore General Hospital

    collaborator OTHER

  • Guy's and St Thomas' NHS Foundation Trust

    collaborator OTHER

  • pSiMedica Limited

    lead INDUSTRY

Principal Investigators

  • Pierce KH Chow, MBBS, PhD · Singapore General Hospital

  • Paul Ross, MBBS,PhD · Guy's and St Thomas' NHS Foundation Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Completion
2008-06-30

Countries

  • Singapore
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00346281 on ClinicalTrials.gov