Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer (DESKTOP III)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Procedure: Tumor Debulking Surgery (surgery in recurrent ovarian disease) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer |
- 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 ] [ Designated as safety issue: Yes ]
- Quality of Life [ Time Frame: Baseline, 6, and 12 months after randomization ] [ Designated as safety issue: No ]EORTC QLQ 30 and FACT NCCN Ovarian Symptom Index
- Progression free survival [ Time Frame: Progression free survival is defined as interval between date of randomization and 2nd relapse/progression or death (whatever occurs first). ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 408 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control Arm - Chemotherapy only
Chemotherapy for platinum-sensitive Ovarian Cancer can be selected on investigators choice
|
|
|
Experimental: Procedure/Surgery
Maximum effort cytoreductive surgery
|
Procedure: Tumor Debulking Surgery (surgery in recurrent ovarian disease)
Surgery for Patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score predictive for complete tumor resection
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Contact: Philipp Harter, MD | +49 (0)611 880 4670 | office-wiesbaden@ago-ovar.de |
| Contact: Andreas du Bois, Professor | +49 (0)611 880 4670 | office-wiesbaden@ago-ovar.de |
| Germany | |
| Ostalbklinikum | Recruiting |
| Aalen, Germany, 73430 | |
| Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde | Recruiting |
| Berlin, Germany, 13353 | |
| Univerisity Hospital; Dept. of Gynecology & Obstetrics | Recruiting |
| Erlangen, Germany, 91054 | |
| University hospital, Dept. of gynecology & obstetrics | Recruiting |
| Essen, Germany, 45122 | |
| Contact: , MD | |
| Kliniken Essen Mitte, Evang. Huyssens-Stiftung | Not yet recruiting |
| Essen, Germany | |
| Klinikum Esslingen | Recruiting |
| Esslingen, Germany, 73730 | |
| Klinikum der JWG Universität Frankfurt | Recruiting |
| Frankfurt am Main, Germany, 60591 | |
| Universitätsklinikum Freiburg, Frauenklinik | Recruiting |
| Freiburg, Germany, 79106 | |
| Gynecologic Clinic of the Ernst-Moritz-Arndt-University | Recruiting |
| Greifswald, Germany, 17487 | |
| Medizinische Hochschule | Recruiting |
| Hannover, Germany, 30625 | |
| Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik f. Gynäkologie u. Geburtshilfe | Recruiting |
| Kiel, Germany, 24105 | |
| Klinikum der Philipps-Universität Marburg, Klinik für Gynäkologie, Gynäkologische Endokrinologie | Recruiting |
| Marburg, Germany, 35037 | |
| St. Josefsklinik | Recruiting |
| Offenburg, Germany, 77654 | |
| St. Vincenz-Krankenhaus | Recruiting |
| Paderborn, Germany, 33098 | |
| Klinikum Südstadt | Recruiting |
| Rostock, Germany, 18059 | |
| Universitätsklinikum, Universitätsfrauenklinik | Recruiting |
| Ulm, Germany, 89075 | |
| HSK, Dr. Horst Schmidt Klinik GmbH | Recruiting |
| Wiesbaden, Germany | |
| Contact office-wiesbaden@ago-ovar.de | |
| Klinikum der Stadt Wolfsburg | Recruiting |
| Wolfsburg, Germany, 38440 | |
More Information
No publications provided
| Responsible Party: | AGO Study Group |
| ClinicalTrials.gov Identifier: | NCT01166737 History of Changes |
| Other Study ID Numbers: | AGO-OVAR OP.4 DESKTOP III |
| Study First Received: | July 16, 2010 |
| Last Updated: | May 29, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by AGO Study Group:
|
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 |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases |
ClinicalTrials.gov processed this record on May 16, 2013