Unique ID issued by UMIN | UMIN000010250 |
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Receipt number | 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 15:52:44 |
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
ANZGOG-0701 Symptom Benefit Study
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
ANZGOG-0701 Symptom Benefit Study
Japan | North America | Australia |
Europe |
Women with platinum resistant/refractory ovarian cancers who are about to start 2nd or subsequent line chemotherapy
Obstetrics and Gynecology |
Malignancy
NO
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
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.
Exploratory
Not applicable
A clinically significant difference as determined by changes in subjective symptoms, objective responses and QoL scores from baseline to post treatment assessment
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
Observational
18 | years-old | <= |
Not applicable |
Female
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.
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800
1st name | |
Middle name | |
Last name | Professor Michael Friedlander/ Professor Phyllis Butow |
Prince of Wales Hospital/The University of Sydney
-/-
BARKER STREET RANDWICK NSW 2031 Australia/Brennan MacCallum Building (A18) The University of Sydney NSW 2006 Australia
(61-2-9382-2222)(61-2-9351-2859)
symptombenefit@ctc.usyd.edu.au
1st name | |
Middle name | |
Last name | Takaaki Takenaga,Director |
Symptom Benefit Reseach Coordinating Center
Cinical Trial Coordinating Center, Kitasato Academic Research Organization, Kitasato University
5-9-1 SHIROKANE MINATO-KU TOKYO 108-8642 JAPAN
03-5791-6398
global@insti.kitasato-u.ac.jp
ANZGOG
University of Sydney
Australia New Zealand Gynecological Oncology Group (ANZGOG)
Outside Japan
Australia
Japanese Gynecologic Oncology Group/
Gynecologic Oncology Trial and Investigation Consortium of North Kanto
YES
ANZCTRN12607000603415
ANZCTR
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
2013 | Year | 03 | Month | 15 | Day |
Unpublished
Completed
2012 | Year | 04 | Month | 11 | Day |
2012 | Year | 12 | Month | 01 | Day |
2015 | Year | 12 | Month | 31 | Day |
2015 | Year | 12 | Month | 31 | Day |
2015 | Year | 12 | Month | 31 | Day |
-
2013 | Year | 03 | Month | 15 | Day |
2016 | Year | 09 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011826
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