Status:
COMPLETED
Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer
Lead Sponsor:
AGO Study Group
Collaborating Sponsors:
ARCAGY/ GINECO GROUP
Grupo Español de Investigación en Cáncer de Ovario
Conditions:
Fallopian Tube Cancer
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
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 can...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT01166737
Start Date
July 1 2010
End Date
December 31 2020
Last Update
January 25 2022
Active Locations (86)
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1
Medizinische Universität Graz, Universitätsklinik für Frauenheilkunde Graz, Abteilung Gynäkologie u. Geburtshilfe
Graz, Austria, 8036
2
Universitätsklinikum Innsbruck, Univ. Klinik für Gynäkologie und Geburtshilfe
Innsbruck, Austria, 6020
3
Medizinische Universität Wien,Universitätsklinik für Frauenheilkunde
Vienna, Austria, 1090
4
Wilhelminenspital der Stadt Wien, Gynäkologisch und Geburtshilfliche Abteilung
Vienna, Austria, 1160