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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
ARCAGY/ GINECO GROUP
MITO
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
GlaxoSmithKline
medac GmbH
Grupo Español de Investigación en Cáncer de Ovario
NSGO
MaNGO
Cancer Research UK
Korean Gynecologic Oncology Group
Shanghai Gynecologic Oncology Group
Information provided by (Responsible Party):
AGO Study Group
ClinicalTrials.gov Identifier:
NCT01166737
First received: July 16, 2010
Last updated: December 22, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Procedure: Tumor Debulking Surgery (surgery in recurrent ovarian disease)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by AGO Study Group:

Primary Outcome Measures:
  • Overall survival in patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score [ Time Frame: Approximately 36 months after last patient randomized and observation of 244 events ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Baseline, 6, and 12 months after randomization ] [ Designated as safety issue: No ]
    EORTC QLQ 30 and FACT NCCN Ovarian Symptom Index

  • Progression free survival [ Time Frame: Progression free survival is defined as interval between date of randomization and 2nd relapse/progression or death (whatever occurs first). ] [ Designated as safety issue: No ]

Estimated Enrollment: 408
Study Start Date: July 2010
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Arm - Chemotherapy only
Chemotherapy for platinum-sensitive Ovarian Cancer can be selected on investigators choice
Experimental: Procedure/Surgery
Maximum effort cytoreductive surgery
Procedure: Tumor Debulking Surgery (surgery in recurrent ovarian disease)
Surgery for Patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score predictive for complete tumor resection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166737

  Show 86 Study Locations
Sponsors and Collaborators
AGO Study Group
ARCAGY/ GINECO GROUP
MITO
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
GlaxoSmithKline
medac GmbH
Grupo Español de Investigación en Cáncer de Ovario
NSGO
MaNGO
Cancer Research UK
Korean Gynecologic Oncology Group
Shanghai Gynecologic Oncology Group
Investigators
Principal Investigator: Philipp Harter, MD AGO Study Group
  More Information

Responsible Party: AGO Study Group
ClinicalTrials.gov Identifier: NCT01166737     History of Changes
Other Study ID Numbers: AGO-OVAR OP.4 DESKTOP III 
Study First Received: July 16, 2010
Last Updated: December 22, 2015
Health Authority: Germany: Ethics Commission

Keywords provided by AGO Study Group:
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

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on May 26, 2016