Residual TumorNCT02980185
Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer
An observational study of Residual Tumor and Disease-free Survival, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
To assess the feasibility, Residual Tumor, complication rate and survival of totally laparoscopic primary cytoreduction in carefully selected patients with Advanced Ovarian Cancer, compared with abdominal primary cytoreduction in a single-Institution, single-surgeon prospective series. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Residual Tumor, Disease-free Survival, Overall Survival
- What is being tested?
- Laparoscopic primary cytoreduction
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2007to Oct 2016
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing primary cytoreduction for stage III-IV ovarian cancer at the Sacred Heart Hospital, Negrar, Italy
Who may be able to join
- Primary Ovarian cancer
- Epithelial histotype
- Stage III-IV disease
Who cannot join
- Anesthesiological contraindication to primary cytoreduction
- Extension of disease contraindicating primary cytoreduction
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Obstetrics and Gynecology Universita' Dell'Insubria
Varese, 21100
About this study
Official title: Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer: a Prospective Validation and Comparison With Open Surgery.
To assess the feasibility, Residual Tumor, complication rate and survival of totally laparoscopic primary cytoreduction in carefully selected patients with Advanced Ovarian Cancer, compared with abdominal primary cytoreduction in a single-Institution, single-surgeon prospective series.
Read the detailed description
All patients with presumed stage III-IV ovarian cancer and clinical conditions allowing aggressive surgery were candidate to possible primary cytoreduction with the aim of achieving residual tumor=0. A definite protocol was adopted: after radiological preoperative evaluation with PET-CT scan, all patients underwent laparoscopic evaluation with the Fagotti score. Once considered suitable for primary debulking surgery, the possibility of attempting laparoscopic cytoreduction was carefully evaluated using strict selection criteria; patients were divided in two groups, based on the type of surgical approach. At the end of laparoscopic primary cytoreduction, a ultra-low pubic minilaparotomy was performed to extract surgical specimens and to perform laparoscopic hand-assisted exploration of the abdominal organs, in order to ensure complete excision of the disease. Surgical data, optimal cytoreduction (defined as residual tumor=0) rates and survival outcomes were investigated.
- Conditions
- Residual Tumor, Disease-free Survival, Overall Survival
- Being tested
- Laparoscopic primary cytoreduction
- Medical subject headings
- Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic primary cytoreductionProcedure or surgery
Primary cytoreduction for ovarian cancer performed through a completely minimally-invasive approach
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic primary cytoreduction | Patients in whom primary cytoreduction was performed using a laparoscopic approach Receives: Procedure: Laparoscopic primary cytoreduction | |
| Abdominal primary cytoreduction | Patients in whom primary cytoreduction was performed using an open abdominal approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual tumor at the end of surgery (using the completeness of cytoreduction score)
Measured: June 2007 - July 2015
Secondary outcomes (2)
Disease-free Survival
Measured: June 2007 - July 2016
Overall Survival
Measured: June 2007 - July 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startJun 2007
- Primary completionJul 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Residual TumorStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Uccella, Università degli Studi dell'Insubria
- Investigators
- Stefano Uccella, MD, PhD, Study chair, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980185
- Sponsor's protocol ID
- 541
- Status last verified
- Nov 2016
- First submitted
- 26 Nov 2016
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nezhat FR, DeNoble SM, Liu CS, Cho JE, Brown DN, Chuang L, Gretz H, Saharia P. The safety and efficacy of laparoscopic surgical staging and debulking of apparent advanced stage ovarian, fallopian tube, and primary peritoneal cancers. JSLS. 2010 Apr-Jun;14(2):155-68. doi: 10.4293/108680810X12785289143990.
PubMed 20932362Ceccaroni M, Roviglione G, Bruni F, Clarizia R, Ruffo G, Salgarello M, Peiretti M, Uccella S. Laparoscopy for primary cytoreduction with multivisceral resections in advanced ovarian cancer: prospective validation. "The times they are a-changin"? Surg Endosc. 2018 Apr;32(4):2026-2037. doi: 10.1007/s00464-017-5899-9. Epub 2017 Oct 19.
PubMed 29052073
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer: a Prospective Validation and Comparison With Open Surgery.
- ClinicalTrials.gov ID
- NCT02980185
- Acronym / sponsor ID
- 541
- Conditions
- Residual Tumor, Disease-free Survival, Overall Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 2 Dec 2016 (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.
To assess the feasibility, Residual Tumor, complication rate and survival of totally laparoscopic primary cytoreduction in carefully selected patients with Advanced Ovarian Cancer, compared with abdominal primary cytoreduction in a single-Institution, single-surgeon prospective series.
Detailed description
All patients with presumed stage III-IV ovarian cancer and clinical conditions allowing aggressive surgery were candidate to possible primary cytoreduction with the aim of achieving residual tumor=0. A definite protocol was adopted: after radiological preoperative evaluation with PET-CT scan, all patients underwent laparoscopic evaluation with the Fagotti score. Once considered suitable for primary debulking surgery, the possibility of attempting laparoscopic cytoreduction was carefully evaluated using strict selection criteria; patients were divided in two groups, based on the type of surgical approach. At the end of laparoscopic primary cytoreduction, a ultra-low pubic minilaparotomy was performed to extract surgical specimens and to perform laparoscopic hand-assisted exploration of the abdominal organs, in order to ensure complete excision of the disease. Surgical data, optimal cytoreduction (defined as residual tumor=0) rates and survival outcomes were investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic primary cytoreduction | – | Procedure: Laparoscopic primary cytoreductionPatients in whom primary cytoreduction was performed using a laparoscopic approach |
| Abdominal primary cytoreduction | – | –Patients in whom primary cytoreduction was performed using an open abdominal approach |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing primary cytoreduction for stage III-IV ovarian cancer at the Sacred Heart Hospital, Negrar, Italy
Key inclusion criteria (3 listed)
- Primary Ovarian cancer
- Epithelial histotype
- Stage III-IV disease
Key exclusion criteria (2 listed)
- Anesthesiological contraindication to primary cytoreduction
- Extension of disease contraindicating primary cytoreduction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic primary cytoreductionPrimary cytoreduction for ovarian cancer performed through a completely minimally-invasive approach | Procedure or surgery | Laparoscopic primary cytoreduction |
Primary outcome
Residual tumor at the end of surgery (using the completeness of cytoreduction score)
Time frame: June 2007 - July 2015
2 secondary outcomes
Disease-free Survival
Time frame: June 2007 - July 2016
Overall Survival
Time frame: June 2007 - July 2016
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 2 Dec 2016.
- Background: PubMed 20932362Nezhat FR, DeNoble SM, Liu CS, Cho JE, Brown DN, Chuang L, Gretz H, Saharia P. The safety and efficacy of laparoscopic surgical staging and debulking of apparent advanced stage ovarian, fallopian tube, and primary peritoneal cancers. JSLS. 2010 Apr-Jun;14(2):155-68. doi: 10.4293/108680810X12785289143990.
- Derived from this study: PubMed 29052073Ceccaroni M, Roviglione G, Bruni F, Clarizia R, Ruffo G, Salgarello M, Peiretti M, Uccella S. Laparoscopy for primary cytoreduction with multivisceral resections in advanced ovarian cancer: prospective validation. "The times they are a-changin"? Surg Endosc. 2018 Apr;32(4):2026-2037. doi: 10.1007/s00464-017-5899-9. Epub 2017 Oct 19.
- Individual participant dataSharing planned: No
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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.
Stefano Uccella, MD, PhD study chair
Università degli Studi dell'Insubria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Residual Tumor and Disease-free Survival, run by Università degli Studi dell'Insubria at 1 site in Italy.
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 2 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 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
What does the primary outcome measure?
Residual tumor at the end of surgery (using the completeness of cytoreduction score) (time frame: June 2007 - July 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02980185, which also lists 2 linked publications.
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 2 Dec 2016.