It is still not clear whether a positive AGO-score just selects patients with less aggressive biologic tumor behavior who as well would have had a positive outcome by chemotherapy only, or , if it is a score selecting patients who really benefit from surgery. Nevertheless, the AGO-score was confirmed to select patients with a less than 30% risk of ending with residual tumor after surgery for recurrent disease. This could avoid including patients into the present surgical protocol who could not benefit from an operationThe goal of this third DESKTOP study is to evaluate in a prospectively randomized multicentre setting, whether maximum effort of cytoreductive surgery followed by platinum based combination chemotherapy can improve overall survival as compared to platinum based combination chemotherapy alone in AGO-score positive patients.
A predictive score identifying patients who might achieve a complete resection is deemed necessary to select the right patients for a prospective trial on cytoreductive surgery in relapsed ovarian cancer. Study centres are selected due to their surgical experience in ovarian cancer and/or participation in prior surgical trials in this field. Patients who matched eligibility criteria were allocated randomly 1:1 prospectively to cytoreductive surgery followed by platinum based combination chemotherapy or to platinum based combination chemotherapy alone .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
408
Surgery for Patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score predictive for complete tumor resection
Medizinische Universität Graz, Universitätsklinik für Frauenheilkunde Graz, Abteilung Gynäkologie u. Geburtshilfe
Graz, Austria
Universitätsklinikum Innsbruck, Univ. Klinik für Gynäkologie und Geburtshilfe
Innsbruck, Austria
Medizinische Universität Wien,Universitätsklinik für Frauenheilkunde
Vienna, Austria
Wilhelminenspital der Stadt Wien, Gynäkologisch und Geburtshilfliche Abteilung
Vienna, Austria
UZ Leuven
Leuven, Belgium
Overall survival
in patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score
Time frame: Approximately 36 months after last patient randomized and observation of 244 events
Progression free survival
patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score
Time frame: Progression free survival is defined as interval between date of randomization and 2nd relapse/progression or death (whatever occurs first).
Quality of Life measures with EORTC QLQ-C30 Global Health Status (GHS)
GHS scale-core item 29, 30; ranges 0-100
Time frame: Baseline, 6, and 12 months after randomization
Quality of Life measures with EORTC QLQ-C30 Symptom Scale Insomnia
Item 11, ranges 0-100
Time frame: Baseline, 6, and 12 months after randomization
Quality of Life measures with EORTC QLQ-C30 Symptom Scale Constipation
Item 16, ranges 0-100
Time frame: Baseline, 6, and 12 months after randomization
Quality of Life measures with FACT-G total score
Composite of 27 items regarding physical, functional, social/family and emotional well-being. from 0-108
Time frame: Baseline, 6, and 12 months after randomization
Quality of Life measures with FACT-O Ovarian Cancer subscale
Composite of 11 items regarding specific to Ovarian Cancer patients, ranges 0-44
Time frame: Baseline, 6, and 12 months after randomization
Quality of Life measures with FACT-O total score
Sum of FACT-G and and Ovarian Cancer subscale, ranges 0-152
Time frame: Baseline, 6, and 12 months after randomization
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Zhejiang Cancer Hospital, Gynecology Oncology
Hangzhou, China
Fudan University Cancer Hospital, Gynecologic Oncology
Shanghai, China
Fudan University Zhongshan Hospital, Obstetrics and Gynecology
Shanghai, China
Suzhou Municipal Hospital, Gynecologic and Obstetrics
Suzhou, China
Aalborg Hospital
Aalborg, Denmark
...and 76 more locations