Peritoneal CarcinomatosisNCT02803515
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) : Predictive Marker and Mechanism
A study testing peripheral venous blood samples in people with Peritoneal Carcinomatosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Peritoneal carcinomatosis (PC) is the stage III of the FIGO ovarian cancer staging. It corresponds to an advanced stage with a relative 5 year survival rate of 52%. The multimodal treatment approach combines neoadjuvant chemotherapy, cytoreductive surgery of macroscopic lesions, and hyperthermic intraperitoneal… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Peritoneal Carcinomatosis
- What is being tested?
- peripheral venous blood samples
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2017to 2 Jul 2017
- Phase
- Interventional
- 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
Who may be able to join
- Females over 18 years.
- Indication of Hyperthermic Intra Peritoneal Chemotherapy (HIPEC) for peritoneal carcinomatosis from ovarian origin
- Obtaining written informed consent and signed for participation in the study and conservation of samples taken.
- Affiliation to a social security scheme.
- Non-inclusion criteria
- Major patients protected by law or deprived of liberty.
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- Patients pregnant women in labor or breastfeeding.
- Refusal of participation
- Another cause of peritoneal carcinomatosis
Who cannot join
- consent withdrawn
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HSP90 as a Predictive Marker of the Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Peritoneal Carcinomatosis From Ovarian Origin.
Peritoneal carcinomatosis (PC) is the stage III of the FIGO ovarian cancer staging. It corresponds to an advanced stage with a relative 5 year survival rate of 52%. The multimodal treatment approach combines neoadjuvant chemotherapy, cytoreductive surgery of macroscopic lesions, and hyperthermic intraperitoneal chemotherapy (HIPEC). It has significantly improved survival rate in patients with ovarian PC and decreased recurrence and mortality rate by 21%. The efficacy of HIPEC is based on chemotherapy potentiated by the hyperthermia (43°). However, the cellular mechanisms involved are not fully understood, but they include cell death pathways and heat shock proteins (Hsp70 and Hsp90). RICCI et al. showed, based on pre-clinical models, that the efficacy of HIPEC was partly due to the overexpression and exposure of HSP90 on the cell surface leaded to an anti-cancer immune response. The aims of this study are to validate these findings in tissue samples of patients with ovarian PC. We will constitute a bank of isolated tumor samples before and after HIPEC and measure postoperative HSP90 serum levels in order to establish if they are predictive of a response. HSPs expression on the cancer cell surface will be determined by flow cytometry. Forty-four patients will be included. Elucidating the underlying mechanisms of HIPEC will broaden therapeutic possibilities including the use of new immunotherapy. The multimodal approach could improve the efficacy of HIPEC with a minimal systemic toxicity.
- Conditions
- Peritoneal Carcinomatosis
- Being tested
- peripheral venous blood samples
- Keywords
- intra peritonal chemo hyperthermia, peritoneal carcinomatosis, ovarian cancer
- Medical subject headings
- Peritoneal Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral venous blood samplesBiological
peripheral venous blood samples measured preoperatively and postoperatively HIPEC (Day 1, day 3 and day 5 postoperative)
| Study group | Role | What they receive |
|---|---|---|
| Patient with HIPEC | Experimental | Not described Receives: Biological: peripheral venous blood samples |
| Patient without HIPEC | Sham comparator | Not described Receives: Biological: peripheral venous blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum levels of HSP90 and 70 on peripheral venous samples.
Changes in serum levels of HSP90 and 70 postoperatively HIPEC (Day 1, day 3 and day 5 postoperative) compared to basal levels measured preoperatively on peripheral venous samples. Patients who had HIPEC will be compared with patients overturned on early intervention
Measured: basal levels (preoperatively), postoperatively HIPEC (Day 1, day 3 and day 5 postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start16 Jan 2017
- Primary completion2 Jul 2017
- Study completion2 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CarcinomatosisStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc BEREDER, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803515
- Sponsor's protocol ID
- 16-AOI-11
- Status last verified
- Aug 2019
- First submitted
- 14 Jun 2016
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HSP90 as a Predictive Marker of the Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Peritoneal Carcinomatosis From Ovarian Origin.
- ClinicalTrials.gov ID
- NCT02803515
- Acronym / sponsor ID
- 16-AOI-11
- Conditions
- Peritoneal Carcinomatosis
- Keywords
- intra peritonal chemo hyperthermia, peritoneal carcinomatosis, ovarian cancer
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 2 Jul 2017 (actual)
- Study completion
- 2 Jul 2017 (actual)
- First posted
- 17 Jun 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.
Peritoneal carcinomatosis (PC) is the stage III of the FIGO ovarian cancer staging. It corresponds to an advanced stage with a relative 5 year survival rate of 52%. The multimodal treatment approach combines neoadjuvant chemotherapy, cytoreductive surgery of macroscopic lesions, and hyperthermic intraperitoneal chemotherapy (HIPEC). It has significantly improved survival rate in patients with ovarian PC and decreased recurrence and mortality rate by 21%. The efficacy of HIPEC is based on chemotherapy potentiated by the hyperthermia (43°). However, the cellular mechanisms involved are not fully understood, but they include cell death pathways and heat shock proteins (Hsp70 and Hsp90). RICCI et al. showed, based on pre-clinical models, that the efficacy of HIPEC was partly due to the overexpression and exposure of HSP90 on the cell surface leaded to an anti-cancer immune response. The aims of this study are to validate these findings in tissue samples of patients with ovarian PC. We will constitute a bank of isolated tumor samples before and after HIPEC and measure postoperative HSP90 serum levels in order to establish if they are predictive of a response. HSPs expression on the cancer cell surface will be determined by flow cytometry. Forty-four patients will be included. Elucidating the underlying mechanisms of HIPEC will broaden therapeutic possibilities including the use of new immunotherapy. The multimodal approach could improve the efficacy of HIPEC with a minimal systemic toxicity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with HIPEC | Experimental | Biological: peripheral venous blood samples |
| Patient without HIPEC | Sham comparator | Biological: peripheral venous blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Females over 18 years.
- Indication of Hyperthermic Intra Peritoneal Chemotherapy (HIPEC) for peritoneal carcinomatosis from ovarian origin
- Obtaining written informed consent and signed for participation in the study and conservation of samples taken.
- Affiliation to a social security scheme.
- Non-inclusion criteria
Key exclusion criteria (1 listed)
- consent withdrawn
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 |
|---|---|---|
| peripheral venous blood samplesperipheral venous blood samples measured preoperatively and postoperatively HIPEC (Day 1, day 3 and day 5 postoperative) | Biological | Patient with HIPEC, Patient without HIPEC |
Primary outcome
Changes in serum levels of HSP90 and 70 on peripheral venous samples.
Time frame: basal levels (preoperatively), postoperatively HIPEC (Day 1, day 3 and day 5 postoperative)
Changes in serum levels of HSP90 and 70 postoperatively HIPEC (Day 1, day 3 and day 5 postoperative) compared to basal levels measured preoperatively on peripheral venous samples. Patients who had HIPEC will be compared with patients overturned on early intervention
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Marc BEREDER, MD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peripheral venous blood samples in people with Peritoneal Carcinomatosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 9 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: stopped early, as of the sponsor's last update on 4 Sep 2019. 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 France. 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. Some participants in this study may receive a placebo. 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 was stopped early. Results are not available in the source record.
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?
Changes in serum levels of HSP90 and 70 on peripheral venous samples. (time frame: basal levels (preoperatively), postoperatively HIPEC (Day 1, day 3 and day 5 postoperative)). 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 4 Sep 2019.