Peritoneal Carcinomatosis From Colorectal or Ovarian Origin Clinical Trial
— CHIPOfficial title:
Intra Peritoneal Chemo Hyperthermia (IPCH) : Cellular and Metabolic Consequences
Intra Peritoneal Chemo Hyperthermia (IPCH) is a recently validated option for the treatment
of peritoneal carcinomatosis from colorectal or ovarian origin. This therapeutic program
demonstrated a significant improvement of the late stages (i.e. carcinomatosis) of the
disease. From a clinical point of view, within the first 24 hours after IPCH, patients
undergo a systemic inflammatory response syndrome, and therefore require to be monitored in
an intensive care unit. From a metabolic perspective, preliminary data have been shown a
significant "anaerobic style" disturbance of energetic metabolism, suggesting a deep
cellular energetic deficit throughout IPCH process.
Putative contradictory effects of IPCH, like the increase of chemotherapy-related cellular
toxicity due to heat and on the other hand the initiation of a stress protein response (heat
shock response) which helps to reduce the cell injuries, leads to conduct a research project
on the underlying mechanisms: consequences, in terms of patient's care and follow-up, are of
high relevance.
The primary goal is a multimodal assessment of the IPCH-related cell modifications:
signaling pathways, apoptosis and antitumoral immune response.
The assessment criteria include Heat shock protein expression (blood/cell ratio) compared to
baseline values, apoptosis and immune response before/after IPCH.
The scheduled sample size is 30 patients having an IPCH and 30 patients contraindicated per
surgery.
| Status | Terminated |
| Enrollment | 60 |
| Est. completion date | July 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - adult patient - eligible for IPCH - with a social security number - having a signed an informed consent Exclusion Criteria: - study refusal - parturiants - psychiatric disorders |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| France | Département d'Anesthésie Réanimation, CHU de Nice | Nice |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nice |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | heat shock protein expression (blood/cell ratio)compared to baseline values | 7 blood samples over 72 hours (meaning less than 40 ml), including 4 samples under general anesthesia throughout surgery and 3 samples during the 3 following days (at 24th, 48th and 72th hours). 6 tissue biopsies, i.e. 2 from peritoneum disease-free and 2 from invaded peritoneum , each representing a volume less than 1 cm3 and 2 biopsies from healthy colonic tissue for the colon-related cancer and 4 biopsies (peritoneum n=2, tumoral tissue n=2) for ovarian-related cancer. All biopsies are done during the surgery under general anesthesia, and each biopsy per site before/after IPCH. |
samples taken under general anesthesia throughout surgery and during the 3 following days (24h, 48h,72h) | No |