Peritoneal Carcinomatosis From Ovarian CancerPhase 3CARCINOHIPECNCT02328716
Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube or Primary Peritoneal Carcinoma
A Phase 3 study testing Cytoreduction and Hipec with Cisplatin in people with Peritoneal Carcinomatosis From Ovarian Cancer and Fallopian Tube Carcinoma, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial summary
The purpose of this clinical trial is to Investigate whether the administration of HIPEC with Cisplatin (75 milligrams per square meter of body surface) after surgical cytoreduction in women with ovarian, tubal or primary peritoneal carcinoma increased disease-free survival period compared with patients without HIPEC… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma
- What is being tested?
- Cytoreduction and Hipec with Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2012to Dec 2018
- Phase
- Phase 3
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peritoneal carcinomatosis arising from ovarian epithelial carcinoma (stage III or higher), carcinoma of the fallopian tube and primary peritoneal carcinoma.
- Residual tumor < 2.5 mm after completion of cytoreductive surgery.
- Aged < 75 years.
- Baseline ECOG 0-1 (Eastern Cooperative Oncologic Group).
- Adequate bone marrow function with hemoglobin ? 8 g/dl (after correction for iron deficiency anemia), white blood cell count ? 3,000/mm3, platelets ? 100,000/mm3.
- Adequate renal function with creatinine ? 1.5 mg/ dl.
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- Adequate liver function with bilirubin levels ? 1.5 mg / dl and AST and ALT ? 80 IU / L.
- Optimal cardiopulmonary function.
- In recurrences, disease-free interval > 6 months.
- Voluntary and signed written informed consent.
Who cannot join
- Extraperitoneal tumor disease.
- Suboptimal debulking (residual tumor > 2.5 mm).
- Previous history of other malignancies (excluding skin)
- Intestinal obstruction at the time of evaluation.
- Renal failure.
- Heart failure.
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- Uncontrolled infection.
- Pregnant or lactating patients.
- In recurrences, disease-free interval < 6 months.
Trial locations and contacts
1 site in 1 country.
Pedro Cascales Campos, MD,PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Pedro Cascales Campos, 968369500
Pedro Cascales Campos, M.D
About this study
Official title: Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube or Primary Peritoneal Carcinoma : Randomized Clinical Trial.
The purpose of this clinical trial is to Investigate whether the administration of HIPEC with Cisplatin (75 milligrams per square meter of body surface) after surgical cytoreduction in women with ovarian, tubal or primary peritoneal carcinoma increased disease-free survival period compared with patients without HIPEC treatment.
- Conditions
- Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma
- Being tested
- Cytoreduction, Hipec with Cisplatin
- Medical subject headings
- Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoreductionProcedure or surgery
Cytoreduction
Hipec with CisplatinDrug
Intraoperative Intraperitoneal Hyperthermic Chemotherapy (Hipec)+Cisplatin
| Study group | Role | What they receive |
|---|---|---|
| Comparator | Active comparator | Comparator Receives: Procedure: Cytoreduction |
| Experimental | Experimental | Experimental Receives: Procedure: Cytoreduction; Drug: Hipec with Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival period
Every three months until recurrence of disease.
Measured: Every 3 months up to 30 months
Secondary outcomes (4)
Evaluation of overall survival.
Every three months until recurrence of disease.
Measured: Every 3 months up to 30 months
Study of morbidity.
Every three months until recurrence of disease.
Measured: Every 3 months up to 30 months
Evaluation of quality of life related to the procedure.
Every three months until recurrence of disease.
Measured: Every 3 months up to 30 months
Study of Ex vivo correlation.
in vitro cell culture to study the effect of temperature and cisplatin on cell viability
Measured: 4 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startFeb 2012
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
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 Peritoneal Carcinomatosis From 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro Cascales Campos, M.D Phd, Study director, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328716
- Sponsor's protocol ID
- EC-GC/AD-01/11
- Other IDs
- 2011-001715-31
- Acronym
- CARCINOHIPEC
- Status last verified
- Dec 2017
- First submitted
- 5 Dec 2014
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cascales Campos PA, Gonzalez-Gil A, Gomez-Ruiz AJ, Gil-Gomez E, Alconchel-Gago F, Navarro-Barrios A, Martinez-Garcia J, Alonso-Romero JL, Nieto A, Barcelo-Valcarcel F, Gil-Martinez J. Risk factors and management of incisional hernia after cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal surface malignancies. Hernia. 2020 Apr;24(2):257-263. doi: 10.1007/s10029-019-01962-4. Epub 2019 May 8.
PubMed 31069579
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube or Primary Peritoneal Carcinoma : Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02328716
- Acronym / sponsor ID
- CARCINOHIPEC / EC-GC/AD-01/11
- Conditions
- Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 31 Dec 2014 (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 clinical trial is to Investigate whether the administration of HIPEC with Cisplatin (75 milligrams per square meter of body surface) after surgical cytoreduction in women with ovarian, tubal or primary peritoneal carcinoma increased disease-free survival period compared with patients without HIPEC treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparator | Active comparator | Procedure: CytoreductionComparator |
| Experimental | Experimental | Procedure: Cytoreduction, Drug: Hipec with CisplatinExperimental |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Peritoneal carcinomatosis arising from ovarian epithelial carcinoma (stage III or higher), carcinoma of the fallopian tube and primary peritoneal carcinoma.
- Residual tumor < 2.5 mm after completion of cytoreductive surgery.
- Aged < 75 years.
- Baseline ECOG 0-1 (Eastern Cooperative Oncologic Group).
- Adequate bone marrow function with hemoglobin ? 8 g/dl (after correction for iron deficiency anemia), white blood cell count ? 3,000/mm3, platelets ? 100,000/mm3.
Key exclusion criteria (9 listed)
- Extraperitoneal tumor disease.
- Suboptimal debulking (residual tumor > 2.5 mm).
- Previous history of other malignancies (excluding skin)
- Intestinal obstruction at the time of evaluation.
- Renal failure.
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 |
|---|---|---|
| CytoreductionCytoreduction | Procedure or surgery | Comparator, Experimental |
| Hipec with CisplatinIntraoperative Intraperitoneal Hyperthermic Chemotherapy (Hipec)+Cisplatin | Drug | Experimental |
Primary outcome
disease-free survival period
Time frame: Every 3 months up to 30 months
Every three months until recurrence of disease.
4 secondary outcomes
Evaluation of overall survival.
Time frame: Every 3 months up to 30 months
Study of morbidity.
Time frame: Every 3 months up to 30 months
Evaluation of quality of life related to the procedure.
Time frame: Every 3 months up to 30 months
Study of Ex vivo correlation.
Time frame: 4 days post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Derived from this study: PubMed 31069579Cascales Campos PA, Gonzalez-Gil A, Gomez-Ruiz AJ, Gil-Gomez E, Alconchel-Gago F, Navarro-Barrios A, Martinez-Garcia J, Alonso-Romero JL, Nieto A, Barcelo-Valcarcel F, Gil-Martinez J. Risk factors and management of incisional hernia after cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal surface malignancies. Hernia. 2020 Apr;24(2):257-263. doi: 10.1007/s10029-019-01962-4. Epub 2019 May 8.
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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.
Pedro Cascales Campos, MD,PhD contact
Pedro Cascales Campos, M.D Phd study director
Hospital Universitario Virgen de la Arrixaca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cytoreduction and Hipec with Cisplatin in people with Peritoneal Carcinomatosis From Ovarian Cancer and Fallopian Tube Carcinoma, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Dec 2017. 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 Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro Cascales Campos, MD,PhD, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival period (time frame: Every 3 months up to 30 months). 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 NCT02328716, 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 13 Dec 2017.