Study of the Isotopic Distribution of Intraperitoneal Chemotherapy for Peritoneal Carcinomatosis of Ovarian Origin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study

NCT00968799

Epithelial Ovarian Cancer Fallopian Tube Carcinoma

TERMINATED NA

Intra-peritoneal Chemotherapy in Ovarian Cancer

NCT02861872

Ovarian Neoplasms Immune Tolerance Neoplasms +1 more

UNKNOWN

Early Chemotherapy Based on CA 125 Level Alone Compared With Delayed Chemotherapy in Treating Patients With Recurrent Ovarian Epithelial , Fallopian Tube, or Primary Peritoneal Cancer

NCT00002895

Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer

COMPLETED PHASE3

Dose Escalation of Cisplatin Hyperthermic Intraperitoneal Chemotherapy After Surgery in Patients With Unresectable Stage IIIC Ovarian, Tube or Peritoneal Primary Adenocarcinoma

NCT02217956

Ovarian Adenocarcinoma Fallopian Tube Adenocarcinoma Primary Peritoneal Carcinoma

COMPLETED PHASE1

Neoadjuvant Chemotherapy in Epithelial Ovarian Cancer

NCT02125513

Ovarian Cancer Fallopian Tube Carcinoma Peritoneal Carcinoma

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention arm

Patients will receive an intraperitoneal chemotherapy (cisplatin) combined to a radiotracer (nanocis) in order to assess the intraperitoneal distribution of the chemotherapy

Group Type EXPERIMENTAL

Intraperitoneal cisplatin with nanocis

Intervention Type DRUG

Patients will receive an intraperitoneal chemotherapy combined to a radiotracer in order to assess the intraperitoneal distribution of the chemotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intraperitoneal cisplatin with nanocis

Patients will receive an intraperitoneal chemotherapy combined to a radiotracer in order to assess the intraperitoneal distribution of the chemotherapy

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No