NCT00346281

Brief 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_2 pancreatic-cancer

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_2 pancreatic-cancer

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2006

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

June 29, 2006

Status Verified

June 1, 2006

First QC Date

June 27, 2006

Last Update Submit

June 28, 2006

Conditions

Pancreatic Cancer

Keywords

unresectable pancreatic cancerbrachytherapy32PBioSiliconlocally advancedgemcitabineintratumourallyunresectable

Outcome Measures

Primary Outcomes (1)

  • Safety profile of the patients defined by the Adverse Events profile.

Secondary Outcomes (1)

  • Will assess ease of use, tumour response, duration of response, progression free survival and overall survival. Target tumour response summaries for the study will be performed.

Interventions

32P BioSiliconDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven locally advanced or metastatic adenocarcinoma of the pancreas
  • Advanced pancreatic disease, not amenable to surgical resection
  • Measurable disease by CT scan, with a tumour burden equivalent to a diameter of no less than 3cm and no greater than 6cm
  • ECOG Performance status 0 - 2
  • Life expectancy at least three months
  • Laboratory parameters:
  • Hb greater than or equal to 10 g/dl Platelets greater than or equal to 100,000 mm3 ANC greater than or equal to 1500/mm3 Bilirubin \< 1.3 x ULN Alkaline phosphatase \< 5 x ULN Transaminases \< 5 x ULN Creatinine \< 1.5 x ULN Prothrombin (PT) and partial thromboplastin time (PTT) within normal range Serum calcium within normal range
  • All patients of reproductive potential must agree to use an effective barrier method of contraception during the study and for six months following termination of treatment.
  • Male and female patients aged 18 or over who have provided written informed consent

You may not qualify if:

  • Any previous treatment with 32 Phosphorus or with 32P BioSiliconTM
  • Any prior radiotherapy for pancreatic cancer
  • Use of other investigational agent at the time of enrolment, or within 30 days or five half-lives of enrolment, whichever is longer
  • History of hypersensitivity to any of the study products or to products with similar chemical structures (i.e. silicon or phosphorous)
  • History of malignancy of any other organ system, treated or untreated, within the past five years whether or not there is evidence of local recurrence or metastases, with the exception of localised basal cell carcinoma of the skin and in situ cervical carcinoma
  • Pregnant or lactating women
  • Significant tumour related pain for which analgesic intervention incorporating epidural or EUS is planned

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Singapore General Hospital

Outram Road, 169608, Singapore

RECRUITING

Guy's and St Thomas' Hospital NHS Trust

London, SE1 9RT, United Kingdom

RECRUITING

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Pierce KH Chow, MBBS, PhD

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

  • Paul Ross, MBBS,PhD

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 29, 2006

Study Start

June 1, 2006

Study Completion

June 1, 2008

Last Updated

June 29, 2006

Record last verified: 2006-06

Locations

GB(1)SG(1)