Ovarian CancerNCT02856841
The Preoperative Predictors of Optimal Cytoreductive Surgery in Women With Advanced Ovarian Cancer
An observational study of Ovarian Cancer, run by Cairo University.
Trial summary
44 patients were enrolled in this study as they had malignant epithelial ovarian tumor.Pre-operative staging was assessed by CT scan based on FIGO classification and compared to the standard laparotomy surgical staging. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: 44 patients were enrolled in this study as they had malignant epithelial ovarian tumor (EOC), FIGO stage II, III, and IV.
Who may be able to join
- malignant epithelial ovarian tumor (EOC)
- FIGO stage II, III, and IV.
Who cannot join
- Patients with previous abdominal or pelvic major surgery, synchronous abdominal or pelvic pathology or medically unfit for surgery
About this study
Official title: The Preoperative Predictors of Optimal Cytoreductive Surgery in Women With Advanced Epithelial Ovarian Cancer
44 patients were enrolled in this study as they had malignant epithelial ovarian tumor.Pre-operative staging was assessed by CT scan based on FIGO classification and compared to the standard laparotomy surgical staging. Maximal surgical effort for Optimum cytoreduction was achieved and the risk factors for sub-optimal cytoreduction were studied
Read the detailed description
Each patient was subjected to comprehensive medical history taking and careful clinical examination, laboratory investigations (CA-125) and imaging (abdomino-pelvic CT scan). Patients with suspected bowel involvement were subjected for colonoscopy.
Pre-operative Abdomino-pelvic CT scans:
Preoperative CT scans were performed with a high-speed scanner after the oral and intravenous administration of contrast medium. The hard copy images were reviewed by consultant radiologists for assessment of the findings suggestive of malignant adnexal mass which are bilateral lesions, thick septa, enhancing solid components, ascites, and peritoneal deposits .
Pre-operative staging of cancer ovary was assessed by CT scan based on FIGO classification:
- Stage II: tumor involving ovaries with pelvic extension +/- ascites.
- Stage III: tumor involving ovaries with peritoneal implant outside pelvis +/- ascites.
- Stage IV: tumor involving ovaries with parenchymal liver metastasis and/or pleural effusion.
Surgical treatment:
All patients underwent standard longitudinal laparotomy, intensive surgical staging and maximal surgical effort for Optimum cytoreduction which was included all of the following (total abdominal hysterectomy, bilateral salpingo-oophorectomy, infracolic-omentectomy, appendectomy, surgical removal of all tumor masses, intestinal resections if required).Achievement of no gross residual disease has been attempted in all cases. Finally, patients were divided into two groups:
- Suboptimal cytoreduction group with any gross tumor residue.
- Optimal cytoreduction group without any gross tumor residue.
Surgical risk factors for optimum cytoreduction:
- Parenchymal liver involvement.
- Omental involvement.
- Bowel involvement.
- Para aortic lymph node involvement.
- Peritoneal carcinomatosis: it is defined as disease > 4 mm involving 2 or more of the following areas; lateral colic gutters, anterior abdominal wall, diaphragm, and pelvic peritoneal reflections.
- Pelvic sidewall invasion: it is defined as presence of one or more of the following; tumor fixed to the pelvic bony wall, encasement of iliac vessels, and hydroureter.
- Conditions
- Ovarian Cancer
- Keywords
- epithelial ovarian cancer, optimum cytoreduction
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| optimum cytoreduction | without any gross tumor residue after surgery | |
| Suboptimum cytoreduction | with any gross tumor residue after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of optimum cytoreduction
ability to remove all gross lesions from the tumor intraoperatively and leaving no ovarian lesion seen by naked eye of the expert surgeon
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856841
- Sponsor's protocol ID
- 152
- Status last verified
- Aug 2016
- First submitted
- 1 Aug 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preoperative Predictors of Optimal Cytoreductive Surgery in Women With Advanced Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02856841
- Acronym / sponsor ID
- 152
- Conditions
- Ovarian Cancer
- Keywords
- epithelial ovarian cancer, optimum cytoreduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Aug 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.
44 patients were enrolled in this study as they had malignant epithelial ovarian tumor.Pre-operative staging was assessed by CT scan based on FIGO classification and compared to the standard laparotomy surgical staging. Maximal surgical effort for Optimum cytoreduction was achieved and the risk factors for sub-optimal cytoreduction were studied
Detailed description
Each patient was subjected to comprehensive medical history taking and careful clinical examination, laboratory investigations (CA-125) and imaging (abdomino-pelvic CT scan). Patients with suspected bowel involvement were subjected for colonoscopy.
Pre-operative Abdomino-pelvic CT scans:
Preoperative CT scans were performed with a high-speed scanner after the oral and intravenous administration of contrast medium. The hard copy images were reviewed by consultant radiologists for assessment of the findings suggestive of malignant adnexal mass which are bilateral lesions, thick septa, enhancing solid components, ascites, and peritoneal deposits .
Pre-operative staging of cancer ovary was assessed by CT scan based on FIGO classification:
- Stage II: tumor involving ovaries with pelvic extension +/- ascites.
- Stage III: tumor involving ovaries with peritoneal implant outside pelvis +/- ascites.
- Stage IV: tumor involving ovaries with parenchymal liver metastasis and/or pleural effusion.
Surgical treatment:
All patients underwent standard longitudinal laparotomy, intensive surgical staging and maximal surgical effort for Optimum cytoreduction which was included all of the following (total abdominal hysterectomy, bilateral salpingo-oophorectomy, infracolic-omentectomy, appendectomy, surgical removal of all tumor masses, intestinal resections if required).Achievement of no gross residual disease has been attempted in all cases. Finally, patients were divided into two groups:
- Suboptimal cytoreduction group with any gross tumor residue.
- Optimal cytoreduction group without any gross tumor residue.
Surgical risk factors for optimum cytoreduction:
- Parenchymal liver involvement.
- Omental involvement.
- Bowel involvement.
- Para aortic lymph node involvement.
- Peritoneal carcinomatosis: it is defined as disease > 4 mm involving 2 or more of the following areas; lateral colic gutters, anterior abdominal wall, diaphragm, and pelvic peritoneal reflections.
- Pelvic sidewall invasion: it is defined as presence of one or more of the following; tumor fixed to the pelvic bony wall, encasement of iliac vessels, and hydroureter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| optimum cytoreduction | – | –without any gross tumor residue after surgery |
| Suboptimum cytoreduction | – | –with any gross tumor residue after surgery |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 44 patients were enrolled in this study as they had malignant epithelial ovarian tumor (EOC), FIGO stage II, III, and IV.
Key inclusion criteria (2 listed)
- malignant epithelial ovarian tumor (EOC)
- FIGO stage II, III, and IV.
Key exclusion criteria (1 listed)
- Patients with previous abdominal or pelvic major surgery, synchronous abdominal or pelvic pathology or medically unfit for surgery
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
feasibility of optimum cytoreduction
Time frame: 1 year after surgery
ability to remove all gross lesions from the tumor intraoperatively and leaving no ovarian lesion seen by naked eye of the expert surgeon
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 5 Aug 2016.
- Individual participant dataSharing planned: Yes
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
Ahmed Maged, MD principal investigator
Kasr Alainy medical school
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Cairo University.
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 2 inclusion and 1 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 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
feasibility of optimum cytoreduction (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2016.