Oxaliplatin in PIPAC for Nonresectable Peritoneal Metastases of Digestive Cancers
Oxaliplatin in PIPAC for Nonresectable Peritoneal Metastases of Digestive Cancers
Current curative treatment of digestive peritoneal carcinomatosis consists of complete
 cytoreduction surgery associated with intraperitoneal chemotherapy. This treatment has
 important limits: a high morbimortality and the impossibility of repeating the sessions. The
 majority of patients are therefore treated with systemic chemotherapy, which despite its
 progress, remains palliative.

 Pressurized Intraperitoneal aerosol chemotherapy (PIPAC) has many advantages: under
 laparoscopy, low morbidity, good intratumoral penetration of cytotoxics, possibility of
 repeating the sessions and low financial cost.

 Therefore, the investigator propose a phase 1 study, in colorectal and stomach cancer, with
 oxaliplatin doses escalation in Pressurized Intraperitoneal aerosol chemotherapy. It would
 allow a better tumor response, with potentially few risks and thus improve survival in
 patients with digestive peritoneal carcinoses, increasing access to cytoreductive surgery.
Inclusion Criteria:

 1. Patient age ≥ 18 years

 2. Histological or cytological diagnosis of peritoneal carcinoma of colorectal, gastric
 or gray primitive

 3. Having previously received at least 3 months of systemic chemotherapy for metastatic
 disease (type of chemotherapy left to the discretion of each investigator). Patients
 who received chemotherapy with bevacizumab (Avastin®) more than 2 months ago may be
 included.

 4. Irritable or extensive peritoneal carcinosis:

 Extended peritoneal carcinoma of gastric adenocarcinoma (PCI score> 5) Extended
 peritoneal carcinoma of adenocarcinoma (PCI score> 13) Extended peritoneal carcinoma
 of colorectal adenocarcinoma (PCI score> 15)

 5. ECOG performance index < or = 2 (see Annex 8)

 6. Life expectancy> 3 months

 7. Peripheral neuropathy grade ≤ 1

 8. Hematological function: Hemoglobin ≥ 9 g / dL, leukocytes ≥ 4000 / mm3, PNN ≥ 1500 /
 mm3, platelets ≥ 100 000 / mm3

 9. creatinine clearance> 50 mL / min (cockcroft and Gault formula)

 10. Hepatic function: Total bilirubin ≤ 1.5 x ULN, ASAT and ALAT ≤ 3 x ULN, Alkaline
 phosphatases ≤ 3 x ULN

 11. Patient without deficiency or with partial deficiency in Dihydropyrimidine
 dehydrogenase (i.e. DPD)

 12. Effective contraception for women of childbearing age

 13. Informing the patient and obtaining free, informed and written consent signed by the
 patient and his / her investigator.

 14. Affiliated subject or beneficiary of the social security scheme.

 Exclusion Criteria:

 1. Patients who received bevacizumab (Avastin®) less than 2 months ago can not be
 included

 2. Extra-peritoneal metastases, except for less than 3 pulmonary nodules (each size <5mm)

 3. Known hypersensitivity to Oxaliplatin

 4. Complete deficiency of Dihydropyrimidine dehydrogenase (i.e. DPD)

 5. Grade 1> grade 1 peripheral neuropathy due to or not with Oxaliplatin previously used

 6. Active active or other serious underlying disease that may prevent the patient from
 receiving treatment

 7. Intracranial or intraocular hypertension (ongoing at the time of inclusion)

 8. Severe or Severe Heart Failure (ongoing at the time of inclusion)

 9. Complete intestinal obstruction (ongoing at the time of inclusion)

 10. Other concurrent cancer or history of cancer other than in situ cancer of treated
 cervix or basal cell carcinoma or squamous cell carcinoma

 11. Pregnant or nursing women

 12. Persons deprived of their liberty or under guardianship or unable to give their
 consent

 13. Inability to submit to medical follow-up of the trial for geographical, social or
 psychological reasons

 14. Long-term corticosteroids (duration> 3 months), except for weaning for at least 3
 months