Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000322235
Ethics application status
Approved
Date submitted
31/03/2009
Date registered
21/05/2009
Date last updated
21/06/2021
Date data sharing statement initially provided
21/06/2021
Date results information initially provided
21/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of advanced organ imaging in radiotherapy of the upper-abdomen for kidney response assessment and treatment optimisation
Scientific title
In radiotherapy treatment of upper-abdominal cancer patients, can response assessment with functional single photon emission computed tomography (SPECT) imaging be used to reduce kidney toxicity and improve the radiotherapy?
Secondary ID [1] 304557 0
Nil known
Universal Trial Number (UTN)
Trial acronym
RAPRASI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic cancer 4548 0
Stomach cancer 4549 0
Condition category
Condition code
Cancer 237129 237129 0 0
Pancreatic
Cancer 237130 237130 0 0
Stomach

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
External beam radiotherapy for pancreatic or stomach cancer to 54 Gy in 30 daily (excluding weekends) fractions. Sequential SPECT imaging with 99m-Technetium-dimercaptosuccinic acid (99Tc-DMSA) at commencement of radiotherapy (0 weeks) and at 4, 12, 26, 52 and 78 weeks
Intervention code [1] 4560 0
Treatment: Other
Intervention code [2] 4561 0
Diagnosis / Prognosis
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5698 0
Observed change in regional kidney function as indicated by SPECT signal
Timepoint [1] 5698 0
Baseline, 4 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks
Primary outcome [2] 5699 0
Change in glomerular filtration rate (GFR) measured via serum creatinine in blood analysis
Timepoint [2] 5699 0
Baseline, 4 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks
Secondary outcome [1] 242051 0
Urea and electrolyte levels assessed via blood analysis
Timepoint [1] 242051 0
Baseline, 4 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks

Eligibility
Key inclusion criteria
Patient has histologically/cytologically proven adenocarcinoma of the pancreas or upper-gastrointestinal (GI) tract. Metastatic disease status excluded on whole body computed tomography (CT) series.
Locoregional staging of primary disease has been undertaken with dual phase (arterial and portal) spiral CT.
Adequate bone marrow function: Haemoglobin (Hb)>10, White Blood Cells (WBC)>3.5 (Neutrophilis>1.5), Platelets >100
Serum creatinine <150
Patient has given written informed consent.
Performance status is East Coast Oncology Group (ECOG) grade 0, 1 or 2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major co-morbid illnesses that, in the opinion of the investigator, would jeopardise the likely completion of the treatment program.
Patients with significant loss of bodyweight (>15% weight loss since diagnosis).
Treatment with any previous cytotoxic chemotherapy for the malignancy.
Previous abdominal radiotherapy.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
3/01/2011
Date of last participant enrolment
Anticipated
Actual
31/12/2017
Date of last data collection
Anticipated
Actual
1/06/2018
Sample size
Target
30
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment postcode(s) [1] 1578 0
6009
Recruitment postcode(s) [2] 34427 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 4741 0
Hospital
Name [1] 4741 0
Sir Charles Gairdner Hospital
Country [1] 4741 0
Australia
Funding source category [2] 308925 0
Government body
Name [2] 308925 0
Australian Commonwealth Department of Health
Country [2] 308925 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Ave
Nedlands
Western Australia 6009
Country
Australia
Secondary sponsor category [1] 4280 0
None
Name [1] 4280 0
N/A
Address [1] 4280 0
N/A
Country [1] 4280 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6782 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 6782 0
Hospital Ave
Nedlands
Western Australia 6009
Ethics committee country [1] 6782 0
Australia
Date submitted for ethics approval [1] 6782 0
Approval date [1] 6782 0
08/12/2008
Ethics approval number [1] 6782 0
2001-152

Summary
Brief summary
Radiotherapy to the upper-abdomen is challenging due to the presence of the kidneys. We will couple single photon emission computed tomography (SPECT) with X-ray computed tomography (CT) to determine the effect of radiotherapy on kidney function. Combining the imaging with information on delivered radiation dose will enable us to examine the complex interactions between radiation and kidney response in order to develop unique models for optimizing radiation dose delivery and predicting outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29455 0
Prof Nigel Spry
Address 29455 0
Department of Radiation Oncology
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA 6009
Country 29455 0
Australia
Phone 29455 0
+61864574931
Fax 29455 0
Email 29455 0
Nigel.Spry@health.wa.gov.au
Contact person for public queries
Name 12702 0
Prof Martin Ebert
Address 12702 0
Department of Radiation Oncology
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA 6009
Country 12702 0
Australia
Phone 12702 0
+61 8 9346 4900
Fax 12702 0
Email 12702 0
Martin.Ebert@health.wa.gov.au
Contact person for scientific queries
Name 3630 0
Prof Martin Ebert
Address 3630 0
Department of Radiation Oncology
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA 6009
Country 3630 0
Australia
Phone 3630 0
+61 8 9346 4900
Fax 3630 0
Email 3630 0
Martin.Ebert@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
Dimensions AIRadiotherapy of abdomen with precise renal assessment with SPECT/CT imaging (RAPRASI): design and methodology of a prospective trial to improve the understanding of kidney radiation dose response2013https://doi.org/10.1186/1471-2407-13-381
N.B. These documents automatically identified may not have been verified by the study sponsor.