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

October 10, 2016 updated by: Centre Jean Perrin

Study of the Isotopic Distribution of Intraperitoneal Postoperative Locoregional 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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • Centre Jean Perrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
Patients will receive an intraperitoneal chemotherapy (cisplatin) combined to a radiotracer (nanocis) in order to assess the intraperitoneal distribution of the chemotherapy
Drug: Intraperitoneal cisplatin with nanocis
Patients will receive an intraperitoneal chemotherapy combined to a radiotracer in order to assess the intraperitoneal distribution of the chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification by visual analysis the intensity of fixation of the solvent characterized in the intraperitoneal cavity
Time Frame: During the 6 cycles of chemotherapy, that is during 18 weeks

The intensity of fixation will be defined as followed:

0: no fixation

  1. fixation of low intensity
  2. fixation of high intensity
During the 6 cycles of chemotherapy, that is during 18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Note adverse events assessed with CTCAE v4.0
Time Frame: During the 6 cycles of chemotherapy, that is during 18 weeks
The treatment-related adverse events will be assessed with CTCAE v4.0
During the 6 cycles of chemotherapy, that is during 18 weeks
Correlate pain intensity to fixation intensity in the peritoneal cavity
Time Frame: During the 6 cycles of chemotherapy, that is during 18 weeks
Pain intensity will be measured with EVA scale
During the 6 cycles of chemotherapy, that is during 18 weeks
dosimetric study with peritoneal scintigraphy
Time Frame: During the 6 cycles of chemotherapy, that is during 18 weeks
This study will be realised only for the first three patients included in the trial
During the 6 cycles of chemotherapy, that is during 18 weeks
Correlate site of relapse to localisation of labeled intraperitoneal solvent by nanocis in peritoneal cavity
Time Frame: During 5 years after chemotherapy
During 5 years after chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Jean Perrin

Investigators

  • Principal Investigator: Christophe Pomel, MD, PhD, Centre Jean Perrin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-004103-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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