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A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer

Phase 3
18 Years
Open (Enrolling)
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer

Inclusion 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

- 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)

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Overall survival in patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score

Outcome Time Frame:

Approximately 36 months after last patient randomized and observation of 244 events

Safety Issue:



Germany: Ethics Commission

Study ID:




Start Date:

July 2010

Completion Date:

December 2016

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • 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
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms