Study of the Isotopic Distribution of Intraperitoneal Chemotherapy for Peritoneal Carcinomatosis of Ovarian Origin
Study of the Isotopic Distribution of Intraperitoneal Chemotherapy for Peritoneal Carcinomatosis of Ovarian Origin
The treatment of advanced ovarian cancer is based on the combination of chemotherapy based on
 platinum salt and surgery whose quality is the major prognostic factor.

 A meta-analysis of retrospective series had shown that for every 10% increase in the complete
 cytoreduction rates were increased by 5.5% overall survival time (Markman et al, 2001).
 Currently, it is recognized that the best chance of survival conferred to patients whose
 initial surgical residue is zero (Harter et al, 2009).

 However, even if macroscopically complete surgery and whatever the type of systemic
 chemotherapy, peritoneal recurrence remains high for more than 75%.

 To reducing it of recurrence, a therapeutic approach is to administer chemotherapy
 intraperitoneally.

 The intraperitoneal chemotherapy consists to administer the drug directly into the peritoneal
 cavity.

 Alberts et al, 1996 and Armstrong et al, 2006 compared the efficacy in terms of survival of
 an intraperitoneal chemotherapy according to this method with a conventional systemic
 chemotherapy. Alberts reported a significant improvement in the median overall survival.
 Armstrong shows in addition a decreased risk of recurrence.

 It must be remembered that:

 -  The establishment of an intra-abdominal catheter does not always ensure complete flow of
 drugs into the peritoneal cavity (major postoperative adhesions).

 -  There may be problems of catheters becoming blocked and requiring local treatment; these
 problems can cause abdominal pain whose care is difficult. Thus almost half of patients
 fail to get all six courses of intraperitoneal chemotherapy.

 Thus, the investigators propose to estimate the flow of intraperitoneal chemotherapy with IP
 peritoneal scintigraphy, using a radiotracer (nanocis®). The investigators hypothesize that
 the movement of colloids in peritoneal cavity is similar to the circulation of chemotherapy
 within the peritoneal cavity (From Forni et al, 1993, Varia et al, 2003, Young et al, 2003,
 Dawson et al, 2011). The accumulation of radiotracer will be more correlated with abdominal
 pain sites described by the patient as well as peritoneal recurrence sites found during
 monitoring.
Epithelial ovarian cancer is the fifth leading cause of female cancer and the leading cause
 of death among gynecological cancers (Alberts et al, 2002). The treatment of advanced ovarian
 cancer is based on the combination of chemotherapy based on platinum salt and surgery whose
 quality is the major prognostic factor.

 A meta-analysis of retrospective series had shown that for every 10% increase in the complete
 cytoreduction rates were increased by 5.5% overall survival time (Markman et al, 2001).
 Currently, it is recognized that the best chance of survival conferred to patients whose
 initial surgical residue is zero (Harter et al, 2009).

 However, even if macroscopically complete surgery and whatever the type of systemic
 chemotherapy, peritoneal recurrence remains high for more than 75%.

 To reducing it of recurrence, a therapeutic approach is to administer chemotherapy
 intraperitoneally.

 The intraperitoneal chemotherapy consists to administer the drug directly into the peritoneal
 cavity at a frequency that is related to systemic chemotherapy (every 3 weeks).

 Alberts et al, 1996 and Armstrong et al, 2006 compared the efficacy in terms of survival of
 an intraperitoneal chemotherapy according to this method with a conventional systemic
 chemotherapy. Alberts reported a significant improvement in the median overall survival (49
 vs 41 months). Armstrong shows in addition a decreased risk of recurrence.

 It must be remembered that:

 -  The establishment of an intra-abdominal catheter does not always ensure complete flow of
 drugs into the peritoneal cavity (major postoperative adhesions).

 -  There may be problems of catheters becoming blocked and requiring local treatment; these
 problems can cause abdominal pain whose care is difficult. Thus almost half of patients
 fail to get all six courses of intraperitoneal chemotherapy.

 Thus, the investigators propose to estimate the flow of intraperitoneal chemotherapy with IP
 peritoneal scintigraphy, using a radiotracer (nanocis®). The investigators hypothesize that
 the movement of colloids in peritoneal cavity is similar to the circulation of chemotherapy
 within the peritoneal cavity (From Forni et al, 1993, Varia et al, 2003, Young et al, 2003,
 Dawson et al, 2011). The accumulation of radiotracer will be more correlated with abdominal
 pain sites described by the patient as well as peritoneal recurrence sites found during
 monitoring.
Inclusion Criteria:

 -  Performance Status 0-2

 -  PNN> 1.5.109 / L (without added GCSF)

 -  Plaquettes> 100. 109 / L

 -  Bilirubine inferior or equal to 1.5 times the upper normal value (VNS)

 -  ASAT And ALT inferior or equal to 2.5 upper normal value (VNS)

 -  Alkaline Phosphatase inferior or equal to2.5 upper normal value (VNS)

 -  Clairance Creatinine> 60ml / min Normal -Ionogramme

 -  PTT <1.5 times the upper normal value (VNS) (heparin, or other accepted lovenox
 anticoagulants)

 -  PT / INR inferior or equal to 1.5 upper normal value (VNS) (or INR between 2 and 3, if
 the patient receives a stabilized dose of Warfarin)

 -  Patient operated first line without macroscopic residual for ovarian cancer or primary
 peritoneal or tubal stage IIIC or IV peritoneal pleural

 -  Minimum Required for surgery: hysterectomy, oophorectomy, pelvic lymphadenectomy and
 para-aortic omentectomy

 -  Patient requiring adjuvant chemotherapy

 -  Compulsory affiliation to a social security scheme.

 -  Obtaining informed consent in writing, signed and dated.

 Exclusion Criteria:

 -  Patient with cognitive and psychiatric disorders.

 -  Patient deprived of liberty by a court or administrative.

 -  Patient having directions against the achievement of chemotherapy

 -  Concomitant treatment with a drug test, participation in another therapeutic clinical
 trial within 30 days

 -  Pregnant women

 -  Nursing women

 -  Patient with recognized hypersensitivity to cisplatin or platinum-containing products

 -  Patient with hypersensitivity recognized paclitaxel or any of the excipients

 -  Patient must be vaccinated against yellow fever

 -  Patient before taking phenytoin for prophylactic purposes

 -  Patient with hearing impairment

 -  Patient with hepatic impairment

 -  Patient with renal impairment Sensory or motor -Neuropathies> grade 1 (CTCAE)

 -  Hépatite Or severe infection requiring parenteral antibiotics

 -  Serious non-healing wound or ulcer, or bone fracture

 -  Fistule Abdominal or gastrointestinal perforation, or intra-abdominal abscess in the
 28 days preceding the intraperitoneal chemotherapy Clinical -Symptômes,
 gastrointestinal obstruction or signs and / or which require a hydration and / or
 parenteral nutrition

 -  Patientes Has had or currently with inflammatory bowel disease

 -  Active bleeding or medical condition that carries a high risk of bleeding (eg, known
 coagulation disorders, coagulopathy, or tumor with large vessels)

 -  Cerebrovascular accident (CVA) or transient ischemic attack, or subarachnoid
 hemorrhage in the last 6 months

 -  Disease clinically significant cardiovascular, including:

 -  uncontrolled hypertension, defined as systolic blood pressure> 150mmHg or
 diastolic> 90mmHg

 -  myocardial infarction or unstable angina within the last 6 months

 -  NYHA class II-IV congestive heart failure

 -  serious cardiac arrhythmia requiring treatment: -an asymptomatic atrial
 fibrillation with controlled ventricular rate supraventricular tachycardia or
 controlled with medication and is authorized asymptomatic peripheral vascular
 disease o ≥ Grade 2 (CTCAE) (brief [less than 24 hours] ischemia episodes managed
 non-surgically and without permanent deficit)

 -  Antecedents of Hemorrhage or stroke (stroke), transient ischemic attack, or
 subarachnoid in the last 6 months Major Surgery within 28 days prior to inclusion