Not provided
Not provided
Not provided
Not provided
Because of the obsolescence of the study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Patients will receive an intraperitoneal chemotherapy (cisplatin) combined to a radiotracer (nanocis) in order to assess the intraperitoneal distribution of the chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraperitoneal cisplatin with nanocis | Drug | Patients will receive an intraperitoneal chemotherapy combined to a radiotracer in order to assess the intraperitoneal distribution of the chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification by visual analysis the intensity of fixation of the solvent characterized in the intraperitoneal cavity | The intensity of fixation will be defined as followed: 0: no fixation
| During the 6 cycles of chemotherapy, that is during 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Note adverse events assessed with CTCAE v4.0 | 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 |
Not provided
Inclusion Criteria:
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:
Antecedents of Hemorrhage or stroke (stroke), transient ischemic attack, or subarachnoid in the last 6 months Major Surgery within 28 days prior to inclusion
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christophe Pomel, MD, PhD | Centre Jean Perrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean Perrin | Clermont-Ferrand | 63000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19955907 | Background | Harter P, Hilpert F, Mahner S, Kommoss S, Heitz F, Pfisterer J, du Bois A. Prognostic factors for complete debulking in first- and second-line ovarian cancer. Int J Gynecol Cancer. 2009 Dec;19 Suppl 2:S14-7. doi: 10.1111/IGC.0b013e3181bffb3f. | |
| 8173187 | Background | de Forni M, Boneu A, Otal P, Martel P, Shubinski R, Bugat R, Lucot H. Anatomic changes in the abdominal cavity during intraperitoneal chemotherapy: prospective study using scintigraphic peritoneography. Bull Cancer. 1993 Apr;80(4):345-50. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C512413 | nanocis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Pain intensity will be measured with EVA scale
| During the 6 cycles of chemotherapy, that is during 18 weeks |
| dosimetric study with peritoneal scintigraphy | 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 | During 5 years after chemotherapy |
| 12885800 | Background | Varia MA, Stehman FB, Bundy BN, Benda JA, Clarke-Pearson DL, Alvarez RD, Long HJ; Gynecologic Oncology Group. Intraperitoneal radioactive phosphorus (32P) versus observation after negative second-look laparotomy for stage III ovarian carcinoma: a randomized trial of the Gynecologic Oncology Group. J Clin Oncol. 2003 Aug 1;21(15):2849-55. doi: 10.1200/JCO.2003.11.018. |
| 14645424 | Background | Young RC, Brady MF, Nieberg RK, Long HJ, Mayer AR, Lentz SS, Hurteau J, Alberts DS. Adjuvant treatment for early ovarian cancer: a randomized phase III trial of intraperitoneal 32P or intravenous cyclophosphamide and cisplatin--a gynecologic oncology group study. J Clin Oncol. 2003 Dec 1;21(23):4350-5. doi: 10.1200/JCO.2003.02.154. |
| 19849742 | Background | Dawson SJ, Hicks RJ, Johnston V, Allen D, Jobling T, Quinn M, Rischin D. Intraperitoneal distribution imaging in ovarian cancer patients. Intern Med J. 2011 Feb;41(2):167-71. doi: 10.1111/j.1445-5994.2009.02112.x. |
| 8960474 | Background | Alberts DS, Liu PY, Hannigan EV, O'Toole R, Williams SD, Young JA, Franklin EW, Clarke-Pearson DL, Malviya VK, DuBeshter B. Intraperitoneal cisplatin plus intravenous cyclophosphamide versus intravenous cisplatin plus intravenous cyclophosphamide for stage III ovarian cancer. N Engl J Med. 1996 Dec 26;335(26):1950-5. doi: 10.1056/NEJM199612263352603. |
| 16394300 | Background | Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |