ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12606000015549

Ethics application status

Approved

Date submitted

9/01/2006

Date registered

10/01/2006

Date last updated

10/01/2006

Type of registration

Prospectively registered

Titles & IDs

Public title

SIRT for metastatic pancreatic cancer

Scientific title

A phase I clinical trial to assess the efficacy of treatment with SIR-Spheres microspheres in patients with liver metastases from primary cancer of the pancreas

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pancreatic cancer with hepatic metastases

Condition category

Condition code

Cancer

Pancreatic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients will receive a single implant of SIR-Spheres microspheres followed by standard treatment with 5-fluorouracil (600 mg/m2) until disease progression or unacceptable toxicity. 4 to 6 weeks after implantation patients will receive gemcitabine (1000 mg/m2) weekly for seven weeks followed by a 1 week break. It will then be administered weekly for 3 weeks, followed by a 1 week break until disease progression or unacceptable toxicity.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Time to progressive disease in the liver

Timepoint [1]

Assessed every 8 weeks until progression is detected

Secondary outcome [1]

Time to progressive disease at any site

Timepoint [1]

Outcomes assessed monthly until progression is detected

Secondary outcome [2]

Clinical Benefit Response

Timepoint [2]

Outcomes assessed monthly until progression is detected

Secondary outcome [3]

Response and stable disease rate (RECIST - CR, PR, SD)

Timepoint [3]

Outcomes assessed monthly until progression is detected

Secondary outcome [4]

Time to treatment failure

Timepoint [4]

Outcomes assessed monthly until progression is detected

Secondary outcome [5]

Site of progressive disease

Timepoint [5]

Outcomes assessed monthly until progression is detected

Secondary outcome [6]

Toxicity resulting from treatment with SIRT + chemotherapy

Timepoint [6]

Outcomes assessed monthly until progression is detected

Secondary outcome [7]

Survival

Timepoint [7]

Outcomes assessed monthly until progression is detected

Eligibility

Key inclusion criteria

Pancreatic adenocarcinoma with contrast CT evidence of measurable liver metastases. Liver metastases should be the dominant site of disease and must be considered as impacting on patient QoL and/or survivalBaseline imaging must be <29 days of trial entry. Suitable for treatmentLife expectancy of at least 2 months without active treatmentPrior treatment of liver metastases is not allowed.Adequate Hematological, hepatic and renal function.WHO performance status 0-1.Willing and able to provide written informed consent.Female patients must be postmenopausal, sterile or using an acceptable method of contraception.

Minimum age

18 Years

Maximum age

Not stated

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Evidence of ascites, cirrhosis or portal hypertension as determined by clinical and radiological assessment.Occlusion of the main portal vein.Central nervous system metastases as determined by CT or MRI scan.Previous radiotherapy to the upper abdomen that included the liver in the treatment field.Evidence of any concurrent condition that would render the patient ineligible for treatment according to the protocol.Hepatic arterial anatomy that would prevent the administration of SIR-Spheres into the liver.>20% arteriovenous lung shunting on a technetium99 - MAA nuclear scan.Female patients who are pregnant or breastfeeding.Participation in a clinical trial of an investigational agent within 30 days of SIRT.

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/02/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

10

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Sirtex Medical Limited

Address [1]

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Sirtex Medical Limited

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Summary

Brief summary

Metatstatic pancreatic cancer is the 5th most lethal cancer killer. For those with hepatic lesions the outlook is 3-5 months with best available care. This study aims to use SIRT (Selective Internal Radiation Therapy) to effectively target and treat the hepatic lesions, thus significantly improving the outlook for patients with this condition.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Michael Tapner

Address

Sirtex Medical Limited
Unit F6
16 Mars Road
Lane Cove NSW 2066

Country

Australia

Phone

+61 2 99361426

Fax

+61 2 99361404

Email

[email protected]

Contact person for scientific queries

Name

Dr Peter Gibbs

Address

Oncology Department
Royal Melbourne Hospital
Parkville VIC 3050

Country

Australia

Phone

+61 3 93427560

Fax

+61 3 93477508

Email

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Phase II trial of selective internal radiation therapy and systemic chemotherapy for liver-predominant metastases from pancreatic adenocarcinoma	2015	https://doi.org/10.1186/s12885-015-1822-8

N.B. These documents automatically identified may not have been verified by the study sponsor.