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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010250
Receipt No. R000011826
Scientific Title 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
Date of disclosure of the study information 2013/03/15
Last modified on 2016/09/16

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Basic information
Public title 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
Acronym ANZGOG-0701 Symptom Benefit Study
Scientific Title 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
Scientific Title:Acronym ANZGOG-0701 Symptom Benefit Study
Region
Japan North America Australia
Europe

Condition
Condition Women with platinum resistant/refractory ovarian cancers who are about to start 2nd or subsequent line chemotherapy
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the criteria for defining a clinically significant subjective improvement and the optimal instrument/s for measuring this benefit in women with platinum resistant/refractory ovarian cancers
Basic objectives2 Others
Basic objectives -Others 1. The proportion of women benefiting from palliative chemotherapy as defined by the criteria developed narrative objectives
2. The time to symptom deterioration
3. The proportion of women who receive treatment because they are (a) symptomatic, (b) have rising tumor markers alone, or (c) have imaging evidence of disease progression
4. The percentage of patients who complete 4 or more cycles of treatment
5. The duration of symptom benefit for those who improved
6. The most common, most severe and most noticed symptoms as perceived by patients.
7. To classify these according to their likelihood of being tumor related symptoms or side effects of prior or current therapy
8. How these symptoms change during the treatment period
9. The relationship between objective tumour response, CA 125 response and subjective responses (HRQOL, symptom scores, anxiety, depression)
10. To investigate and develop prognostic models for benefit, time to progression and survival.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

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

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion 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.
Key exclusion criteria -
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Professor Michael Friedlander/ Professor Phyllis Butow
Organization Prince of Wales Hospital/The University of Sydney
Division name -/-
Zip code
Address BARKER STREET RANDWICK NSW 2031 Australia/Brennan MacCallum Building (A18) The University of Sydney NSW 2006 Australia
TEL (61-2-9382-2222)(61-2-9351-2859)
Email symptombenefit@ctc.usyd.edu.au

Public contact
Name of contact person
1st name
Middle name
Last name Takaaki Takenaga,Director
Organization Symptom Benefit Reseach Coordinating Center
Division name Cinical Trial Coordinating Center, Kitasato Academic Research Organization, Kitasato University
Zip code
Address 5-9-1 SHIROKANE MINATO-KU TOKYO 108-8642 JAPAN
TEL 03-5791-6398
Homepage URL
Email global@insti.kitasato-u.ac.jp

Sponsor
Institute ANZGOG
Institute
Department

Funding Source
Organization University of Sydney
Australia New Zealand Gynecological Oncology Group (ANZGOG)
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Australia

Other related organizations
Co-sponsor Japanese Gynecologic Oncology Group/
Gynecologic Oncology Trial and Investigation Consortium of North Kanto
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 ANZCTRN12607000603415
Org. issuing International ID_1 ANZCTR
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 日本:埼玉医科大学国際医療センター(埼玉県)、東京慈恵会医科大学付属病院(東京都)、鹿児島市立病院(鹿児島県)、佐久総合病院(長野県)、国立病院機構呉医療センター・中国がんセンター(広島県)、徳島大学病院(徳島県)、弘前大学医学部付属病院(青森県)、昭和大学横浜市北部病院(神奈川県)、自治医科大学附属病院(栃木県)、防衛医科大学校病院(埼玉県)、埼玉県立がんセンター(埼玉県)、東北大学病院(宮城県)、国立がん研究センター中央病院(東京都)、東海大学医学部付属病院(神奈川県)、日本大学医学部附属病院(東京都)、大木記念女性のための菊池がんクリニック(埼玉県)、獨協医科大学病院(栃木県)、東京女子医科大学病院(東京都)
オーストラリア、ニュージーランド、アイルランド、スウェーデン、イタリア、カナダ、フランス、ドイツ、イギリス、アメリカ、デンマーク

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 04 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information -

Management information
Registered date
2013 Year 03 Month 15 Day
Last modified on
2016 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011826

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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