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Trial record 1 of 1 for:    NCT01166737
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Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer (DESKTOPIII)

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ClinicalTrials.gov Identifier: NCT01166737
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : January 25, 2022
Sponsor:
Collaborators:
ARCAGY/ GINECO GROUP
Grupo Español de Investigación en Cáncer de Ovario
Cancer Research UK
Shanghai Gynecologic Oncology Group
Information provided by (Responsible Party):
AGO Study Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer Procedure: Tumor Debulking Surgery (surgery in recurrent ovarian disease) Not Applicable

Detailed 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 .

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer
Actual Study Start Date : July 2010
Actual Primary Completion Date : January 17, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: Approximately 36 months after last patient randomized and observation of 244 events ]
    in patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score


Secondary Outcome Measures :
  1. 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). ]
    patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score

  2. Quality of Life measures with EORTC QLQ-C30 Global Health Status (GHS) [ Time Frame: Baseline, 6, and 12 months after randomization ]
    GHS scale-core item 29, 30; ranges 0-100

  3. Quality of Life measures with EORTC QLQ-C30 Symptom Scale Insomnia [ Time Frame: Baseline, 6, and 12 months after randomization ]
    Item 11, ranges 0-100

  4. Quality of Life measures with EORTC QLQ-C30 Symptom Scale Constipation [ Time Frame: Baseline, 6, and 12 months after randomization ]
    Item 16, ranges 0-100

  5. Quality of Life measures with FACT-G total score [ Time Frame: Baseline, 6, and 12 months after randomization ]
    Composite of 27 items regarding physical, functional, social/family and emotional well-being. from 0-108

  6. Quality of Life measures with FACT-O Ovarian Cancer subscale [ Time Frame: Baseline, 6, and 12 months after randomization ]
    Composite of 11 items regarding specific to Ovarian Cancer patients, ranges 0-44

  7. Quality of Life measures with FACT-O total score [ Time Frame: Baseline, 6, and 12 months after randomization ]
    Sum of FACT-G and and Ovarian Cancer subscale, ranges 0-152


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166737


Locations
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Sponsors and Collaborators
AGO Study Group
ARCAGY/ GINECO GROUP
Grupo Español de Investigación en Cáncer de Ovario
Cancer Research UK
Shanghai Gynecologic Oncology Group
Investigators
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Principal Investigator: Philipp Harter, MD AGO Study Group
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AGO Study Group
ClinicalTrials.gov Identifier: NCT01166737    
Other Study ID Numbers: AGO-OVAR OP.4 DESKTOP III
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: January 25, 2022
Last Verified: December 2021
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:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Hypersensitivity
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Immune System Diseases