Brief Title
Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer
Official Title
A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer
Brief Summary
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
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
Primary Outcome
Overall survival
Secondary Outcome
Progression free survival
Condition
Fallopian Tube Cancer
Intervention
Tumor Debulking Surgery (surgery in recurrent ovarian disease)
Study Arms / Comparison Groups
Control Arm - Chemotherapy only
Description: Chemotherapy for platinum-sensitive Ovarian Cancer can be selected on investigators choice
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
408
Start Date
July 2010
Completion Date
December 31, 2020
Primary Completion Date
January 17, 2020
Eligibility 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:
1. Performance status ECOG 0
2. 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.
3. 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)
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Philipp Harter, MD, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT01166737
Organization ID
AGO-OVAR OP.4 DESKTOP III
Responsible Party
Sponsor
Study Sponsor
AGO Study Group
Collaborators
ARCAGY/ GINECO GROUP
Study Sponsor
Philipp Harter, MD, Principal Investigator, AGO Study Group
Verification Date
December 2021