Ovarian CancerNCT04234243
HIPEC in Ovarian Cancer, Case-Controls Study With 10-years Follow up
An observational study of Ovarian Cancer and HIPEC, run by Instituto de Seguridad Social del Estado de Mexico y Municipios.
Trial summary
Objectives: Compare overall survival (OS) and progression-free survival (PFS) among ovarian cancer patients who underwent into cytoreduction and HIPEC procedure vs patients who only received systemic chemotherapy in a 10-years follow up of a case-control study Methods: Cases were defined as patients treated by… Read more about this study
- Who is it for?
- Ages 18 to 72 years, women only
- Conditions the study is for
- Ovarian Cancer, HIPEC
- What is being tested?
- cytoreduction and HIPEC
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2007to 31 Aug 2019
- 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 to 72 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: HIPEC population: 46 patients No HIPEC population : 92 patients
Who may be able to join
- Diagnosis of Epithelial ovarian cancer confirmed
- FIGO stage III-IV or carcinomatosis recurrence
- No comorbidities or controlled comorbidities
- ECOG 0-2
Who cannot join
- without carcinomatosis
About this study
Official title: HIPEC in Ovarian Cancer: The First Case Control Study in Mexican Patients With 10-year Follow-up
Objectives:
Compare overall survival (OS) and progression-free survival (PFS) among ovarian cancer patients who underwent into cytoreduction and HIPEC procedure vs patients who only received systemic chemotherapy in a 10-years follow up of a case-control study
Methods:
Cases were defined as patients treated by cytoreduction and HIPEC, and were matched (1:2) with patients treated with chemotherapy only, defined as controls. PFS and OS in the two groups were measured and compared. PFS was calculated from initiation of treatment to progression, death or to the last known follow-up. OS was calculated from initiation of treatment to death or to the last known follow-up.
Read the detailed description
Epithelial ovarian cancer has the highest mortality of all gynecologic tumors in the world wide. Patients are diagnosed with International Federation of Gynecology and Obstetrics (FIGO) stage III to IV disease in 75%. The 10-year survival of women with advanced-stage ovarian cancer is 10% to 15% and has not improve in the past 20 years. Despite treatment with maximal cytoreductive surgery (CRS) and platinum-based chemotherapy, approximately 70% of patients with advanced-stage disease relapse within 18 months. Given this high number of recurrences, new approaches are needed to improve outcomes for these patients. Historically, peritoneal carcinomatosis represents a devastating form of cancer progression with a very poor prognosis.
Objectives:
Compare overall survival (OS) and progression-free survival (PFS) among ovarian cancer patients who underwent into cytoreduction and HIPEC procedure vs patients who only received systemic chemotherapy in a 10-years follow up of a case-control study
Methods:
Cases were defined as patients treated by cytoreduction and HIPEC, and were matched (1:2) with patients treated with chemotherapy only, defined as controls. PFS and OS in the two groups were measured and compared. PFS was calculated from initiation of treatment to progression, death or to the last known follow-up. OS was calculated from initiation of treatment to death or to the last known follow-up.
- Conditions
- Ovarian Cancer, HIPEC
- Being tested
- cytoreduction and HIPEC
- Keywords
- HIPEC
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytoreduction and HIPECProcedure or surgery
cytoreduction CCR 0-1, and HIPEC close technique
| Study group | Role | What they receive |
|---|---|---|
| HIPEC | women, with ovarian cancer stage III-IV or recurrent with carcinomatosis treated with cytoreduction and HIPEC Receives: Procedure: cytoreduction and HIPEC | |
| No HIPEC | women, with ovarian cancer stage III-IV or recurrent with carcinomatosis, treated with systemic chemotherapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
free overall survival
survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to death date or last consultation (months) Kaplan Meier curve
Measured: 10 years
free recurrence survival
survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to recurrence date (months) Kaplan Meier curve
Measured: 10 years
Secondary outcomes (1)
factors associated with survival
histological and clinical factors associated with survival. uni and multivariate analysis (X2, Cox, U Mann-Witney)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Aug 2007
- Primary completion31 Dec 2017
- Study completion31 Aug 2019
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.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Seguridad Social del Estado de Mexico y Municipios
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Juan Manuel Medina Castro, Instituto de Seguridad Social del Estado de Mexico y Municipios
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234243
- Sponsor's protocol ID
- COE-UEI/05/PT/2016
- Status last verified
- Jan 2020
- First submitted
- 10 Jan 2020
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIPEC in Ovarian Cancer: The First Case Control Study in Mexican Patients With 10-year Follow-up
- ClinicalTrials.gov ID
- NCT04234243
- Acronym / sponsor ID
- COE-UEI/05/PT/2016
- Conditions
- Ovarian Cancer, HIPEC
- Keywords
- HIPEC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Instituto de Seguridad Social del Estado de Mexico y MunicipiosOther government
- Study start
- 1 Aug 2007 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 21 Jan 2020 (actual)
- 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.
Objectives:
Compare overall survival (OS) and progression-free survival (PFS) among ovarian cancer patients who underwent into cytoreduction and HIPEC procedure vs patients who only received systemic chemotherapy in a 10-years follow up of a case-control study
Methods:
Cases were defined as patients treated by cytoreduction and HIPEC, and were matched (1:2) with patients treated with chemotherapy only, defined as controls. PFS and OS in the two groups were measured and compared. PFS was calculated from initiation of treatment to progression, death or to the last known follow-up. OS was calculated from initiation of treatment to death or to the last known follow-up.
Detailed description
Epithelial ovarian cancer has the highest mortality of all gynecologic tumors in the world wide. Patients are diagnosed with International Federation of Gynecology and Obstetrics (FIGO) stage III to IV disease in 75%. The 10-year survival of women with advanced-stage ovarian cancer is 10% to 15% and has not improve in the past 20 years. Despite treatment with maximal cytoreductive surgery (CRS) and platinum-based chemotherapy, approximately 70% of patients with advanced-stage disease relapse within 18 months. Given this high number of recurrences, new approaches are needed to improve outcomes for these patients. Historically, peritoneal carcinomatosis represents a devastating form of cancer progression with a very poor prognosis.
Objectives:
Compare overall survival (OS) and progression-free survival (PFS) among ovarian cancer patients who underwent into cytoreduction and HIPEC procedure vs patients who only received systemic chemotherapy in a 10-years follow up of a case-control study
Methods:
Cases were defined as patients treated by cytoreduction and HIPEC, and were matched (1:2) with patients treated with chemotherapy only, defined as controls. PFS and OS in the two groups were measured and compared. PFS was calculated from initiation of treatment to progression, death or to the last known follow-up. OS was calculated from initiation of treatment to death or to the last known follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIPEC | – | Procedure: cytoreduction and HIPECwomen, with ovarian cancer stage III-IV or recurrent with carcinomatosis treated with cytoreduction and HIPEC |
| No HIPEC | – | –women, with ovarian cancer stage III-IV or recurrent with carcinomatosis, treated with systemic chemotherapy only |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIPEC population: 46 patients No HIPEC population : 92 patients
Key inclusion criteria (4 listed)
- Diagnosis of Epithelial ovarian cancer confirmed
- FIGO stage III-IV or carcinomatosis recurrence
- No comorbidities or controlled comorbidities
- ECOG 0-2
Key exclusion criteria (1 listed)
- without carcinomatosis
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 |
|---|---|---|
| cytoreduction and HIPECcytoreduction CCR 0-1, and HIPEC close technique | Procedure or surgery | HIPEC |
Primary outcome
free overall survival
Time frame: 10 years
survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to death date or last consultation (months) Kaplan Meier curve
free recurrence survival
Time frame: 10 years
survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to recurrence date (months) Kaplan Meier curve
1 secondary outcome
factors associated with survival
Time frame: 10 years
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 29 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and HIPEC, run by Instituto de Seguridad Social del Estado de Mexico y Municipios.
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 4 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 29 Jan 2020. 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?
free overall survival (time frame: 10 years). The study lists 2 primary outcomes in all. 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 29 Jan 2020.