Hyperthermic Intraperitoneal Chemotherapy (HIPEC) : Predictive Marker and Mechanism

NCT02803515 | Terminated

• 1 other identifier: 16-AOI-11
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

intra peritonal chemo hyperthermia; peritoneal carcinomatosis; ovarian cancer

Outcome Measures

Primary Outcomes (1)

• 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

  basal levels (preoperatively), postoperatively HIPEC (Day 1, day 3 and day 5 postoperative)

Study Arms (2)

Patient with HIPEC

EXPERIMENTAL

Biological: peripheral venous blood samples

Patient without HIPEC

SHAM COMPARATOR

Biological: peripheral venous blood samples

Interventions

peripheral venous blood samples BIOLOGICAL

peripheral venous blood samples measured preoperatively and postoperatively HIPEC (Day 1, day 3 and day 5 postoperative)

Patient with HIPEC; Patient without HIPEC

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Major patients protected by law or deprived of liberty.
• Patients pregnant women in labor or breastfeeding.
• Refusal of participation
• Another cause of peritoneal carcinomatosis

You may not qualify if:

• consent withdrawn

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Digestive department - Archet hospital

Nice, 06000, France

Location

MeSH Terms

Conditions

Peritoneal Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Jean-Marc BEREDER, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 17, 2016
• Study Start: January 16, 2017
• Primary Completion: July 2, 2017
• Study Completion: July 2, 2017
• Last Updated: September 4, 2019

Record last verified: 2019-08

Locations

FR (1)