Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Under PIPAC

Institut de Cancérologie de Lorraine20 enrolled

Overview

PIPADN is a pilot monocentric, study with a total duration of 42 months. The purpose of this study is to describe the variation of plasma ctDNA concentration between the 1st and the 3rd PIPAC session in patients with peritoneal carcinomatosis. The improvement of life quality with this type of treatment will also be evaluated though the EORTC QLQ-C30 survey. Each patient will have three PIPAC sessions spaced 6 to 8 weeks apart. Two blood samples will be taken during the first 3 PIPAC sessions, one the day before each procedure and a second one 24 hours afterwards. The EORTC QLQ 30 survey will be completed by patients during the pre-operative consultation and at each post-operative consultation (about 3 weeks after PIPAC sessions).

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Peritoneal Carcinomatosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years old * WHO 0 to 2 * Patient with cancer in the form of peritoneal carcinosmatois not eligible for cytoreduction surgery * A histological diagnosis of the primary tumor or peritoneal carcinomatosis is essential. * Patient with an indication for PIPAC for any reason (whether as part of a clinical research protocol or not). Patients with prior treatment with PIPAC are eligible. * Patients with abdominal metastases or a single metastasis regardless of location (oligometastasis). * For patients of childbearing age need for an effective method of contraception * Informing patients and obtaining informed consent, dated and signed. * Patient affiliated with a social security scheme Exclusion Criteria: * Age \< 18 years old * WHO \> 3 * Patient who may benefit from cytoreduction surgery * Patient with a contraindication to PIPAC * Extra peritoneal disease with the exception of oligometastatic disease * Persons deprived of liberty or under guardianship (including curatorship) * Impossibility to undergo the medical follow-up of the trial for social, geographical or psychological reasons. * For patients of childbearing age without an effective method of contraception * Woman who is pregnant, likely to be pregnant, or breastfeeding

Outcomes

Primary Outcomes

ctDNA

ctDNA concentration change (ng/mL)

Time frame: change from inclusion at 12 weeks

Peritoneal Regression Grading Score (PRGS)

Results of each PIPAC will be evaluated using PRGS. PRGS (Peritoneal Regression Grading Score), going from 1 : no tumor cells, to 4 :solid growth in tumor cells

Time frame: at inclusion

Peritoneal Regression Grading Score (PRGS)

Results of each PIPAC will be evaluated using PRGS. PRGS : (Peritoneal Regression Grading Score), going from 1 : no tumor cells, to 4 :solid growth in tumor cells

Time frame: an average of 6 weeks

Peritoneal Regression Grading Score (PRGS)

Results of each PIPAC will be evaluated using PRGS. PRGS (Peritoneal Regression Grading Score), going from 1 : no tumor cells, to 4 :solid growth in tumor cells

Time frame: an average of 12 weeks

Secondary Outcomes

PIPAC discontinuation

The reason (ei : progression, deterioration of the patient's general condition) of PIPAC discontinuation for patient who have had less than 3 PIPAC sessions

Time frame: an average of 6 week

PIPAC discontinuation

The reason (ei : progression, deterioration of the patient's general condition) of PIPAC discontinuation for patient who have had less than 3 PIPAC sessions

Time frame: an average of 12 weeks

Peritoneal cancer index mesure

Evaluation of disease extent

Time frame: at inclusion

Peritoneal cancer index mesure

Evaluation of disease extent

Time frame: an average of 6 week

Peritoneal cancer index mesure

Evaluation of disease extent

Time frame: an average of 12 weeks

Quality of life mesure

Quality of life will be mesured by EORTC Quality of Life C30 survey. EORTC : European Organization for Research and Treatment of Cancer. Measured from 0 to 35, 0 meaning minimal mictionnal discomfort, 35 meaning maximal mictionnal discomfort

Time frame: At inclusion

Quality of life mesure

Time frame: an average of 3 weeks

Quality of life mesure

Time frame: an average of 9 weeks

Quality of life mesure

Time frame: an average of 15 weeks

Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Under PIPAC

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes