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: February 13, 2017

Last verified: February 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

July 16, 2010

Last Updated Date

February 13, 2017

Start Date ^ICMJE

July 2010

Estimated Primary Completion Date

December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01166737 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quality of Life [ Time Frame: Baseline, 6, and 12 months after randomization ]
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). ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Other

Condition ^ICMJE

Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer

Intervention ^ICMJE

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

Study Arms

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

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

408

Estimated Completion Date

December 2020

Estimated Primary Completion Date

December 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Austria, Belgium, China, Denmark, France, Germany, Italy, Korea, Republic of, Norway, Spain, Sweden, United Kingdom

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01166737

Other Study ID Numbers ^ICMJE

AGO-OVAR OP.4 DESKTOP III

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

AGO Study Group

Study Sponsor ^ICMJE

AGO Study Group

Collaborators ^ICMJE

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 ^ICMJE

Principal Investigator:

Philipp Harter, MD

AGO Study Group

PRS Account

AGO Study Group

Verification Date

February 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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