To compare the Efficacy of additional Tumor DebulKing Surgery versus chemotherapy alone in recurrent Platinum-sensitive Ovarian cancer

Not Applicable

Completed

• Conditions: Ovarian Cancer; Cancer; Malignant neoplasm of ovary

• Registration Number: ISRCTN39361386
• Lead Sponsor: AGO Research GmbH (Germany)

Brief Summary

2017 results presented at ASCO in https://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.5501 (added 15/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-04
• Study Completion: 2017-10-01
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 407

Inclusion Criteria

1. Patients with first recurrence of platinum sensitive, invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage
2. 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 International Federation of Gynecology and Obstetrics (FIGO) stage I. Non cytostatic maintenance therapy not containing platinum will not be considered for this calculation
3. A positive AGO-score. Obligatory requirements for a positive AGO recurrence score in platinum-sensitive disease: Performance status Eastern Cooperative Oncology Group (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).
4. Women aged more than or equal to 18 years
5. Complete resection of the tumor by median laparotomy seems possible (estimated by an experienced surgeon). Intra-abdominal disease has to be excluded by magetic resonance imaging (MRI) / computerised tomography (CT) if other surgical approaches for isolated extra-abdominal recurrences are planned
6. Patients who have given their signed and written informed consent and their consent to data transmission and -processing

Exclusion Criteria

1. Patients with non-epithelial tumors as well as borderline tumors
2. Patients without recurrence who are scheduled for diagnostic/second-look surgery or debulking surgery after completion of chemotherapy
3. More than one prior chemotherapy
4. Patients with second, third, or later recurrence
5. 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
6. 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
7. Only palliative surgery planned
8. Radiological signs suggesting metastases not accessible to surgical removal (i.e. complete resection is deemed impossible)
9. Any concomitant disease not allowing surgery and / or chemotherapy
10. Any medical history indicating excessive peri-operative risk
11. Any current medication inducing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents, bevacizumab)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS) in patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score randomized to cytoreductive surgery followed by chemotherapy of the physician's choice versus chemotherapy of the physician's choice alone (recommended: platinum combination therapy). Overall survival is defined as the interval between date of randomisation and date of death.