Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000603415
Ethics application status
Approved
Date submitted
16/11/2007
Date registered
22/11/2007
Date last updated
13/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Palliative Chemotherapy Improve Symptoms in Women with Recurrent Ovarian Cancer?
Scientific title
Does Palliative Chemotherapy Improve Symptoms in Women with Recurrent Ovarian Cancer?
Secondary ID [1] 495 0
Australia and New Zealand Gynecological Oncology Group: ANZGOG-0701
Universal Trial Number (UTN)
Trial acronym
Symptom Benefit
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Women who have platinum resistant/refractory epithelial ovarian cancer with a life expectancy > 3 months who are about to start palliative chemotherapy. 2558 0
Condition category
Condition code
Cancer 2660 2660 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All patients will fill out a number of health realted quality of life (HRQL) questionnaires prior to, during, and after receiving palliative chemotherapy.
Intervention code [1] 2291 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3570 0
Stage 1:
To determine the symptoms and aspects of HRQL that are rated most severe, troublesome and important by women with platinum resistant/refractory ovarian cancer.
Timepoint [1] 3570 0
Assessed using quality of life questionnaires; before, during, and at end of standard care. During a period of 12-16 weeks treatment, assessment would be prior to each treatment cycle. Since the standard treatment timeframe cannot be specified beforehand, a window of 12-16 weeks has been stated. The questions will be asked at the beginning of a new treatment cycle (probably weekly or 2 weekly and so on).
Primary outcome [2] 3586 0
Stage 2:
To determine the proportion of women benefiting from palliative chemotherapy as defined by a clinically significant improvement in HRQL scores and improvement of symptoms.
To develop a better measure of benefit of palliative chemotherapy than using objective response rate alone.
Timepoint [2] 3586 0
Assessed using quality of life questionnaires; before, during, and at end of standard care. During a period of 12-16 weeks treatment, assessment would be prior to each treatment cycle. Since the standard treatment timeframe cannot be specified beforehand, a window of 12-16 weeks has been stated. The questions will be asked at the beginning of a new treatment cycle (three to four weekly).
Secondary outcome [1] 5975 0
N/A
Timepoint [1] 5975 0
N/A

Eligibility
Key inclusion criteria
*Age >= 18 years
*Histologically confirmed ovarian cancer/primary peritoneal cancer
* Recurrent / progressive disease measured by Cancer Antigen 125 (CA125), radiological or clinical)
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-3
* Life Expectancy > 3 months
* Able to commence treatment within 2 weeks of enrollment
* Sufficient English to complete questionnaires independently in the stage 1 component which will be carried out in selected centers in Australia and New Zealand and Canada
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Any condition that compromises the patient’s ability to give informed consent.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2008
Actual
28/02/2011
Date of last participant enrolment
Anticipated
Actual
10/10/2014
Date of last data collection
Anticipated
Actual
31/12/2015
Sample size
Target
650
Accrual to date
Final
948
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC
Recruitment postcode(s) [1] 328 0
2031
Recruitment outside Australia
Country [1] 658 0
Canada
State/province [1] 658 0
Toronto
Country [2] 659 0
Germany
State/province [2] 659 0
Unknown at this stage
Country [3] 660 0
Italy
State/province [3] 660 0
Unknown at this stage
Country [4] 661 0
Japan
State/province [4] 661 0
Unknown at this stage
Country [5] 662 0
Ireland
State/province [5] 662 0
Not applicable
Country [6] 663 0
United Kingdom
State/province [6] 663 0
Unknown at this stage

Funding & Sponsors
Funding source category [1] 2803 0
Other Collaborative groups
Name [1] 2803 0
ANZGOG Coperative Research Group
Country [1] 2803 0
Australia
Funding source category [2] 2815 0
Government body
Name [2] 2815 0
National Health and Medical Research Council - Clinical Trial Centre
Country [2] 2815 0
Australia
Primary sponsor type
Other Collaborative groups
Name
ANZGOG Co-operative Research Group
Address
Locked Bag 77
Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 2533 0
University
Name [1] 2533 0
Psycho-Oncology Cooperative Research Group (PoCoG)
Address [1] 2533 0
School of Psychology
Brennan MacCallum Building (A18)
University of Sydney
NSW 2006
Country [1] 2533 0
Australia
Other collaborator category [1] 92 0
Hospital
Name [1] 92 0
Princess Margaret Hospital
Address [1] 92 0
610 University Ave
Toronto
Country [1] 92 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4744 0
Cancer Institute of NSW
Ethics committee address [1] 4744 0
Level 1
Biomedical Building
Australian Technology Park
1 Central Avenue (off Garden Road)
Eveleigh NSW 2015
Ethics committee country [1] 4744 0
Australia
Date submitted for ethics approval [1] 4744 0
03/10/2007
Approval date [1] 4744 0
20/12/2007
Ethics approval number [1] 4744 0
Ethics committee name [2] 295466 0
Sydney Local Health District Human Research Ethics Committee
Ethics committee address [2] 295466 0
Suite 210, RPA Medical Centre
Ethics committee country [2] 295466 0
Australia
Date submitted for ethics approval [2] 295466 0
25/09/2013
Approval date [2] 295466 0
18/10/2013
Ethics approval number [2] 295466 0
X13-0172&HREC/13/RPAH/272

Summary
Brief summary
In this research project we will study quality of life issues related to having advanced ovarian cancer and undergoing chemotherapy. We are interested in knowing how women are doing during chemotherapy for ovarian cancer and whether symptom improvement occurs with treatment.
Trial website
Trial related presentations / publications
There are no publications up to date. The statistics team is performing the analysis at the moment
Public notes

Contacts
Principal investigator
Name 28192 0
Prof Michael Friedlander
Address 28192 0
Oncology Day Centre Prince of Wales Hospital Randwick NSW 2031
Country 28192 0
Australia
Phone 28192 0
+61 2 93822606
Fax 28192 0
Email 28192 0
[email protected]
Contact person for public queries
Name 11349 0
Prof Prof Michael Friedlander
Address 11349 0
Oncology Day Centre
Prince of Wales Hospital
Randwick NSW 2031
Country 11349 0
Australia
Phone 11349 0
+61 2 93822606
Fax 11349 0
+61 2 93822588
Email 11349 0
[email protected]
Contact person for scientific queries
Name 2277 0
Prof Michael Friedlander
Address 2277 0
National Health and Medical Research Council - Clinical Trial Centre (NHMRC CTC)
Locked Bag 77
Camperdown NSW 1450
Country 2277 0
Australia
Phone 2277 0
+61 2 93822606
Fax 2277 0
+61 2 93822588
Email 2277 0
[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
SourceTitleYear of PublicationDOI
EmbaseReducing uncertainty: Predictors of stopping chemotherapy early and shortened survival time in platinum resistant/refractory ovarian cancer-The GCIG symptombenefit study.2017https://dx.doi.org/10.1634/theoncologist.2017-0047
EmbaseValidation of the modified Glasgow Prognostic Score (mGPS) in recurrent ovarian cancer (ROC) - Analysis of patients enrolled in the GCIG Symptom Benefit Study (SBS).2018https://dx.doi.org/10.1016/j.ygyno.2017.10.019
EmbasePredictors of progression free survival, overall survival and early cessation of chemotherapy in women with potentially platinum sensitive (PPS) recurrent ovarian cancer (ROC) starting third or subsequent line(>=3) chemotherapy - The GCIG symptom benefit study (SBS).2020https://dx.doi.org/10.1016/j.ygyno.2019.10.001
EmbaseSymptom burden and quality of life with chemotherapy for recurrent ovarian cancer: the Gynecologic Cancer InterGroup-Symptom Benefit Study.2022https://dx.doi.org/10.1136/ijgc-2021-003142
N.B. These documents automatically identified may not have been verified by the study sponsor.