Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer (DESKTOP III)
This study is ongoing, but not recruiting participants.
Sponsor:
AGO Study Group
Collaborators:
ARCAGY/ GINECO GROUP
MITO
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
GlaxoSmithKline
medac GmbH
Grupo Español de Investigación en Cáncer de Ovario
NSGO
MaNGO
Cancer Research UK
Korean Gynecologic Oncology Group
Shanghai Gynecologic Oncology Group
Information provided by (Responsible Party):
AGO Study Group
ClinicalTrials.gov Identifier:
NCT01166737
First received: July 16, 2010
Last updated: February 13, 2017
Last verified: February 2017
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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 |
|---|---|
| Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer | Procedure: Tumor Debulking Surgery (surgery in recurrent ovarian disease) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Other |
| Official Title: | A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer |
Resource links provided by NLM:
Further study details as provided by AGO Study Group:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Quality of Life [ Time Frame: Baseline, 6, and 12 months after randomization ]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). ]
| Estimated Enrollment: | 408 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2020 |
| Estimated Primary Completion Date: | December 2019 (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 (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01166737
Show 86 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166737
Show 86 Study Locations
Sponsors and Collaborators
AGO Study Group
ARCAGY/ GINECO GROUP
MITO
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
GlaxoSmithKline
medac GmbH
Grupo Español de Investigación en Cáncer de Ovario
NSGO
MaNGO
Cancer Research UK
Korean Gynecologic Oncology Group
Shanghai Gynecologic Oncology Group
Investigators
| Principal Investigator: | Philipp Harter, MD | AGO Study Group |
More Information
| 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: | February 13, 2017 |
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 Fallopian Tube Neoplasms Hypersensitivity Peritoneal 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 Fallopian Tube Diseases Immune System Diseases Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases |
ClinicalTrials.gov processed this record on July 14, 2017


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