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NCT01166737 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
NA
Status at capture
COMPLETED
Registry last update
2022-01-25

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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)
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Chemotherapy for platinum-sensitive Ovarian Cancer can be selected on investigators choice
    label
    Control Arm - Chemotherapy only
    type
    NO_INTERVENTION
  2. description
    Maximum effort cytoreductive surgery
    intervention Names
    1. Procedure: Tumor Debulking Surgery (surgery in recurrent ovarian disease)
    label
    Procedure/Surgery
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Procedure/Surgery
    description
    Surgery for Patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score predictive for complete tumor resection
    name
    Tumor Debulking Surgery (surgery in recurrent ovarian disease)
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
FACTORIAL
masking Info
masking
NONE
primary Purpose
OTHER
Enrollment
count
408
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    in patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score
    measure
    Overall survival
    time Frame
    Approximately 36 months after last patient randomized and observation of 244 events
secondary Outcomes
  1. description
    patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score
    measure
    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).
  2. description
    GHS scale-core item 29, 30; ranges 0-100
    measure
    Quality of Life measures with EORTC QLQ-C30 Global Health Status (GHS)
    time Frame
    Baseline, 6, and 12 months after randomization
  3. description
    Item 11, ranges 0-100
    measure
    Quality of Life measures with EORTC QLQ-C30 Symptom Scale Insomnia
    time Frame
    Baseline, 6, and 12 months after randomization
  4. description
    Item 16, ranges 0-100
    measure
    Quality of Life measures with EORTC QLQ-C30 Symptom Scale Constipation
    time Frame
    Baseline, 6, and 12 months after randomization
  5. description
    Composite of 27 items regarding physical, functional, social/family and emotional well-being. from 0-108
    measure
    Quality of Life measures with FACT-G total score
    time Frame
    Baseline, 6, and 12 months after randomization
  6. description
    Composite of 11 items regarding specific to Ovarian Cancer patients, ranges 0-44
    measure
    Quality of Life measures with FACT-O Ovarian Cancer subscale
    time Frame
    Baseline, 6, and 12 months after randomization
  7. description
    Sum of FACT-G and and Ovarian Cancer subscale, ranges 0-152
    measure
    Quality of Life measures with FACT-O total score
    time Frame
    Baseline, 6, and 12 months after randomization
Full study description
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
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 .
Source references
references
  1. citation
    Harter P, Sehouli J, Vergote I, Ferron G, Reuss A, Meier W, Greggi S, Mosgaard BJ, Selle F, Guyon F, Pomel C, Lecuru F, Zang R, Avall-Lundqvist E, Kim JW, Ponce J, Raspagliesi F, Kristensen G, Classe JM, Hillemanns P, Jensen P, Hasenburg A, Ghaem-Maghami S, Mirza MR, Lund B, Reinthaller A, Santaballa A, Olaitan A, Hilpert F, du Bois A; DESKTOP III Investigators. Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer. N Engl J Med. 2021 Dec 2;385(23):2123-2131. doi: 10.1056/NEJMoa2103294.
    pmid
    34874631
    type
    RESULT
  2. citation
    Bommert M, Harter P, Heitz F, du Bois A. When should Surgery be used for Recurrent Ovarian Carcinoma? Clin Oncol (R Coll Radiol). 2018 Aug;30(8):493-497. doi: 10.1016/j.clon.2018.04.006. Epub 2018 May 7.
    pmid
    29743148
    type
    DERIVED
Source notices and limitations
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      source update dates
      1. context
        Updated: May 14, 2025
        datetime
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        display
        May 14, 2025

    Preserved source evidence · Not medical advice