Peritoneal Carcinomatosis
Conditions
Keywords
PIPAC, Peritoneal Carcinomatosis, Circulating tumour DNA, Quality of Life
Brief summary
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).
Interventions
OTHERBlood sample (20 ml) and EORTC QLQC30 survey
Blood sample (20ml) will be taken before and 24h after PIPAC procedure EORTC QLQC30 during pre operative consultation and at each post operative consultations
Sponsors
Institut de Cancérologie de Lorraine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ctDNA | change from inclusion at 12 weeks | ctDNA concentration change (ng/mL) |
| Peritoneal Regression Grading Score (PRGS) | at inclusion | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PIPAC discontinuation | an average of 6 week | The reason (ei : progression, deterioration of the patient's general condition) of PIPAC discontinuation for patient who have had less than 3 PIPAC sessions |
| Peritoneal cancer index mesure | at inclusion | Evaluation of disease extent |
| Quality of life mesure | At inclusion | 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 |
Countries
France
Outcome results
None listed