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

AGO Study Group

Status

Completed

Conditions

Fallopian Tube Cancer

Peritoneal Cavity Cancer

Ovarian Cancer

Treatments

Procedure: Tumor Debulking Surgery (surgery in recurrent ovarian disease)

Study type

Interventional

Funder types

Other

Identifiers

NCT01166737

AGO-OVAR OP.4 DESKTOP III

Details and patient eligibility

About

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.

Full 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 .

Enrollment

408 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)