Ovarian CancerNCT00368420
Validation of a Score of Predictive Factors for Complete Resection in Platinum-sensitive Recurrent Ovarian Cancer
An observational study of Ovarian Cancer, run by AGO Study Group at 12 sites in 4 countries.
Trial summary
The purpose of this study is to validate a score developed by the AGO-OVAR for complete resection of the tumor Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 122 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Sep 2006to Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with recurrence of invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage who have relapsed after a tumor-free interval of at least 6 months after completion of first-line therapy.
Who may be able to join
- Patients with recurrence of invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage who have relapsed after a tumor-free interval of at least 6 months after completion of first-line therapy. The same interval applies to patients with second relapse who are enrolled after completed platinum-containing re-induction therapy.
- Women aged > 18 years
- Patients who have given their signed and written informed consent to data transmission and -processing
Who cannot join
- Patients with non-epithelial tumors as well as borderline tumors
- Patients who undergo second-look surgery or completion surgery after end of chemotherapy or during the interval
- Only for the study collective: patients with second malignancies who have been treated by laparotomy, as well as other neoplasias, if the treatment could interfere with the treatment of relapsed ovarian cancer
- Patients with a third recurrence
- Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former platinum-containing therapy
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Germany8 sites
Klinikum der Johann Wolfgang Goethe Universität
Frankfurt, 60596
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
St. Vincentius Kliniken gAG
Karlsruhe, 76135
Klinikum Landshut gGmbH
Landshut, 84034
Städtisches Krankenhaus Lüneburg
Lüneburg, 21339
Klinikum Neumarkt
Neumarkt, 92318
HSK, Dr. Horst Schmidt Klinik
Wiesbaden, 65199
Klinikum der Stadt Wolfsburg
Wolfsburg, 38440
Italy2 sites
Catholic University of Sacred Heart
Campobasso, 86100
European Institute of Oncology
Milan, 20141
About this study
The purpose of this study is to validate a score developed by the AGO-OVAR for complete resection of the tumor
Read the detailed description
The multicentre retrospective study AGO-DESKTOP OVAR 1 investigated in a multicentre-setting the question of prognostic factors for a successful (i.e. complete) debulking for recurrence. That way, a hypothesis for a score with 3 factors could be developed:
- PS ECOG = 0
- tumor-free after primary surgery (if unknown: FIGO I/II)
- Ascites < 500 ml.
The goal of this study is to evaluate in a prospective multicentre setting, to what extent this retrospectively defined AGO-score has predictive validity. The criterion aimed at is therefore the rate of complete tumor resections if the three score characteristics are present in invasive epithelial platinum-sensitive ovarian-, fallopian tube- or primary peritoneal cancer. This study will be the second in a series of three: (1) hypothesis building for a potential predictive score for resectability, (2) prospective confirmation of the AGO-score, and (3) application of the AGO-score as inclusion criteria for eligible patients in whom a formal comparison of the role of secondary debulking of relapsed ovarian cancer could be performed.
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, recurrence, surgery
- Medical subject headings
- Ovarian Neoplasms, Recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionJul 2008
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGO Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Arbeitsgemeinschaft Gynaekologische Onkologie Austria, MITO
- Investigators
- Philipp Harter, Dr., Principal investigator, Dr. Horst Schmidt Klinik WiesbadenAnnette Hasenburg, PD Dr., Study chair, Universitäts-Frauenklinik FreiburgAndreas du Bois, Prof. Dr., Study director, Dr. Horst Schmidt Klinik Wiesbaden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368420
- Sponsor's protocol ID
- AGO-OVAR OP.2
- Other IDs
- AGO DESKTOP OVAR II
- Status last verified
- Feb 2011
- First submitted
- 23 Aug 2006
- Last updated
- 15 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Harter P, Sehouli J, Reuss A, Hasenburg A, Scambia G, Cibula D, Mahner S, Vergote I, Reinthaller A, Burges A, Hanker L, Polcher M, Kurzeder C, Canzler U, Petry KU, Obermair A, Petru E, Schmalfeldt B, Lorusso D, du Bois A. Prospective validation study of a predictive score for operability of recurrent ovarian cancer: the Multicenter Intergroup Study DESKTOP II. A project of the AGO Kommission OVAR, AGO Study Group, NOGGO, AGO-Austria, and MITO. Int J Gynecol Cancer. 2011 Feb;21(2):289-95. doi: 10.1097/IGC.0b013e31820aaafd.
PubMed 21270612
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Score of Predictive Factors for Complete Resection in Platinum-sensitive Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00368420
- Acronym / sponsor ID
- AGO-OVAR OP.2
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, recurrence, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- AGO Study GroupUniversity, hospital or other
- Collaborators
- Arbeitsgemeinschaft Gynaekologische Onkologie Austria, MITO
- Study start
- Sep 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 24 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to validate a score developed by the AGO-OVAR for complete resection of the tumor
Detailed description
The multicentre retrospective study AGO-DESKTOP OVAR 1 investigated in a multicentre-setting the question of prognostic factors for a successful (i.e. complete) debulking for recurrence. That way, a hypothesis for a score with 3 factors could be developed:
- PS ECOG = 0
- tumor-free after primary surgery (if unknown: FIGO I/II)
- Ascites < 500 ml.
The goal of this study is to evaluate in a prospective multicentre setting, to what extent this retrospectively defined AGO-score has predictive validity. The criterion aimed at is therefore the rate of complete tumor resections if the three score characteristics are present in invasive epithelial platinum-sensitive ovarian-, fallopian tube- or primary peritoneal cancer. This study will be the second in a series of three: (1) hypothesis building for a potential predictive score for resectability, (2) prospective confirmation of the AGO-score, and (3) application of the AGO-score as inclusion criteria for eligible patients in whom a formal comparison of the role of secondary debulking of relapsed ovarian cancer could be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recurrence of invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage who have relapsed after a tumor-free interval of at least 6 months after completion of first-line therapy.
Key inclusion criteria (3 listed)
- Patients with recurrence of invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage who have relapsed after a tumor-free interval of at least 6 months after completion of first-line therapy. The same interval applies to patients with second relapse who are enrolled after completed platinum-containing re-induction therapy.
- Women aged > 18 years
- Patients who have given their signed and written informed consent to data transmission and -processing
Key exclusion criteria (5 listed)
- Patients with non-epithelial tumors as well as borderline tumors
- Patients who undergo second-look surgery or completion surgery after end of chemotherapy or during the interval
- Only for the study collective: patients with second malignancies who have been treated by laparotomy, as well as other neoplasias, if the treatment could interfere with the treatment of relapsed ovarian cancer
- Patients with a third recurrence
- Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former platinum-containing therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2011.
- Results publication: PubMed 21270612Harter P, Sehouli J, Reuss A, Hasenburg A, Scambia G, Cibula D, Mahner S, Vergote I, Reinthaller A, Burges A, Hanker L, Polcher M, Kurzeder C, Canzler U, Petry KU, Obermair A, Petru E, Schmalfeldt B, Lorusso D, du Bois A. Prospective validation study of a predictive score for operability of recurrent ovarian cancer: the Multicenter Intergroup Study DESKTOP II. A project of the AGO Kommission OVAR, AGO Study Group, NOGGO, AGO-Austria, and MITO. Int J Gynecol Cancer. 2011 Feb;21(2):289-95. doi: 10.1097/IGC.0b013e31820aaafd.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Harter, Dr. principal investigator
Dr. Horst Schmidt Klinik Wiesbaden
Annette Hasenburg, PD Dr. study chair
Universitäts-Frauenklinik Freiburg
Andreas du Bois, Prof. Dr. study director
Dr. Horst Schmidt Klinik Wiesbaden
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by AGO Study Group at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Italy, Austria, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00368420, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2011.