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Spots Global Cancer Trial Database for Study of the Isotopic Distribution of Intraperitoneal Chemotherapy for Peritoneal Carcinomatosis of Ovarian Origin

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Trial Identification

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

Official Title: Study of the Isotopic Distribution of Intraperitoneal Postoperative Locoregional Chemotherapy for Peritoneal Carcinomatosis of Ovarian Origin

Study ID: NCT02667925

Conditions

Ovarian Cancer

Study Description

Brief Summary: 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.

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Centre Jean Perrin, Clermont-Ferrand, , France

Contact Details

Name: Christophe Pomel, MD, PhD

Affiliation: Centre Jean Perrin

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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