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UMIN ID: UMIN000010250

Registered date:15/03/2013

Does Palliative Chemotherapy Improve Symptoms in Women with Recurrent Ovarian Cancer? Measuring subjective improvement as well as objective response to estimate the benefit of palliative chemotherapy in women with platinum resistant or refractory ovarian cancer

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Women with platinum resistant/refractory ovarian cancers who are about to start 2nd or subsequent line chemotherapy
Date of first enrollment	2012/12/01
Target sample size	800
Countries of recruitment	Japan,North America,Australia,Europe
Study type	Observational
Intervention(s)

TO Original Data: UMIN

Outcome(s)

Primary Outcome	A clinically significant difference as determined by changes in subjective symptoms, objective responses and QoL scores from baseline to post treatment assessment
Secondary Outcome	1. The proportion of patients experiencing a clinically significant improvement in symptoms 2. Reason for treatment: (a) symptomatic, (b) rising tumor markers alone, or (c) have imaging evidence of disease progression 3. Symptoms rated most severe by patients 4. HRQL scores at baseline, during and after post treatment 5. Causes of major symptoms: ie, predominantly treatment-related, predominantly disease related, or potentially caused by both treatment and disease) 6. Objective tumor response as measured by RECIST or GCIG criteria for CA 125 response 7. Time to symptom deterioration 8. Duration of symptom improvement 9. Time to disease progression 10. Time to death

Primary Outcome

A clinically significant difference as determined by changes in subjective symptoms, objective responses and QoL scores from baseline to post treatment assessment

Secondary Outcome

1. The proportion of patients experiencing a clinically significant improvement in symptoms 2. Reason for treatment: (a) symptomatic, (b) rising tumor markers alone, or (c) have imaging evidence of disease progression 3. Symptoms rated most severe by patients 4. HRQL scores at baseline, during and after post treatment 5. Causes of major symptoms: ie, predominantly treatment-related, predominantly disease related, or potentially caused by both treatment and disease) 6. Objective tumor response as measured by RECIST or GCIG criteria for CA 125 response 7. Time to symptom deterioration 8. Duration of symptom improvement 9. Time to disease progression 10. Time to death

Key inclusion & exclusion criteria

Age minimum	18years-old
Age maximum	Not applicable
Gender	Female
Include criteria	1)Age>=18 years 2) Clinical diagnosis of epithelial ovarian, peritoneal or fallopian tube cancers 3) Recurrent or progressive disease (CA125, radiological or clinical) 4) ECOG PS 0-3 5) Life expectancy > 3 months 6) Planning to start chemotherapy within 2weeks of registration 7) Able to complete questionnaires independently.
Exclude criteria	-

Related Information

Primary Sponsor	ANZGOG
Secondary Sponsor	Japanese Gynecologic Oncology Group/ Gynecologic Oncology Trial and Investigation Consortium of North Kanto
Source(s) of Monetary Support	University of Sydney Australia New Zealand Gynecological Oncology Group (ANZGOG)
Secondary ID(s)	ANZCTRN12607000603415

Contact

public contact
Name	Takaaki Takenaga,Director
Address	5-9-1 SHIROKANE MINATO-KU TOKYO 108-8642 JAPAN Japan
Telephone	03-5791-6398
E-mail	global@insti.kitasato-u.ac.jp
Affiliation	Symptom Benefit Reseach Coordinating Center Cinical Trial Coordinating Center, Kitasato Academic Research Organization, Kitasato University
scientific contact
Name	Professor Michael Friedlander/ Professor Phyllis Butow
Address	BARKER STREET RANDWICK NSW 2031 Australia/Brennan MacCallum Building (A18) The University of Sydney NSW 2006 Australia Japan
Telephone	(61-2-9382-2222)(61-2-9351-2859)
E-mail	symptombenefit@ctc.usyd.edu.au
Affiliation	Prince of Wales Hospital/The University of Sydney -/-

TO Original Data: UMIN