Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

Official Title
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A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Intervention / Treatment
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* Procedure: Tumor Debulking Surgery (surgery in recurrent ovarian disease)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with first recurrence of platinum sensitive, invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage. Progression-free interval of at least 6 months after end of last platinum-containing therapy, or recurrence within 6 months or later after primary surgery if the patient has not received prior chemotherapy in patients with FIGO I. Non cytostatic maintenance therapy not containing platinum will not be considered for this calculation. A positive AGO-score. Obligatory requirements for a positive AGO recurrence score in platinum-sensitive disease: Performance status ECOG 0 No residual tumor after primary surgery (if unknown, alternatively primary FIGO stage I/II). If report from 1st surgery is not available contact study chairman who will decide whether inclusion is possible or not. Absence of ascites (cut off < 500 ml: radiological or ultrasound estimation) Complete resection of the tumor by median laparotomy seems possible Patients who have given their signed and written informed consent and their consent to data transmission and -processing. Exclusion Criteria: Patients with non-epithelial tumors as well as borderline tumors. Patients without recurrence who are scheduled for diagnostic/second-look surgery or debulking surgery after completion of chemotherapy More than one prior chemotherapy Patients with second, third, or later recurrence Patients with second malignancies who have been treated by laparotomy, as well as other neoplasms, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected. Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former first platinum-containing therapy Only palliative surgery planned Radiological signs suggesting metastases not accessible to surgical removal (i.e. complete resection is deemed impossible) Any concomitant disease not allowing surgery and/or chemotherapy Any medical history indicating excessive peri-operative risk Any current medication inducing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents, bevacizumab)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm - Chemotherapy only<br>Chemotherapy for platinum-sensitive Ovarian Cancer can be selected on investigators choice | |
| Experimental: Procedure/Surgery<br>Maximum effort cytoreductive surgery | Procedure: Tumor Debulking Surgery (surgery in recurrent ovarian disease)<br>* Surgery for Patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score predictive for complete tumor resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | in patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score | Approximately 36 months after last patient randomized and observation of 244 events | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score | 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 | Baseline, 6, and 12 months after randomization | 
| Quality of Life measures with EORTC QLQ-C30 Symptom Scale Insomnia | Item 11, ranges 0-100 | Baseline, 6, and 12 months after randomization | 
| Quality of Life measures with EORTC QLQ-C30 Symptom Scale Constipation | Item 16, ranges 0-100 | 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 | 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 | 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 | Baseline, 6, and 12 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Cancer, Cancer of the fallopian tube, Primary peritoneal cancer, Recurrent disease, Platinum-sensitive, Surgery, Chemotherapy, Quality of Life, First recurrence of platinum sensitive:, Fallopian Tube Cancer, or Ovarian Cancer, or Peritoneal Cavity Cancer