Intra-peritoneal Chemotherapy in Ovarian Cancer
Λέξεις-κλειδιά
Αφηρημένη
Ημερομηνίες
| Τελευταία επαλήθευση: | 06/30/2016 |
| Πρώτα υποβλήθηκε: | 07/19/2016 |
| Υποβλήθηκε εκτιμώμενη εγγραφή: | 08/03/2016 |
| Δημοσιεύτηκε για πρώτη φορά: | 08/09/2016 |
| Υποβλήθηκε τελευταία ενημέρωση: | 08/03/2016 |
| Δημοσιεύτηκε η τελευταία ενημέρωση: | 08/09/2016 |
| Ημερομηνία έναρξης της πραγματικής μελέτης: | 06/30/2016 |
| Εκτιμώμενη κύρια ημερομηνία ολοκλήρωσης: | 11/30/2017 |
| Εκτιμώμενη ημερομηνία ολοκλήρωσης μελέτης: | 11/30/2017 |
Κατάσταση ή ασθένεια
Φάση
Ομάδες βραχιόνων
| Μπράτσο | Παρέμβαση / θεραπεία |
|---|---|
| IP Patients women, aged younger than 70 years, who will receive standard IP chemotherapy for advanced epithelial ovarian cancer, who are in an adequate physical and biochemical state to receive chemotherapy will be studied. |
Κριτήρια καταλληλότητας
| Επιλέξιμες ηλικίες για μελέτη | 18 Years Προς την 18 Years |
| Φύλα επιλέξιμα για μελέτη | Female |
| Μέθοδος δειγματοληψίας | Non-Probability Sample |
| Δέχεται υγιείς εθελοντές | Ναί |
| Κριτήρια | Inclusion Criteria: Patients receiving IP chemotherapy and therefore meeting the following criteria: - Primary epithelial ovarian carcinoma FIGO stage III; - Optimal or complete primary debulking (tumor rests ≤ 1cm; - WHO 0 - 2; - Adequate hematological function: WBC ≥ 3. 106/L en Platelets ≥ 100. 106/L, - Adequate renal function (Creatinine clearance >60 ml/min (Cockcroft)) - Adequate liver function tests (bilirubin and/or transaminases <1.25 UNL) Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study (according to the standard IP chemotherapy): - Intestinal stoma proximal to the flexura lienalis; - Postoperative sepsis after primary debulking; - Haemoglobin < 6.0 mMol/L - Extended intraperitoneal adhesions; - Neurotoxicity grade>1; - Previous chemotherapy for ovarian carcinoma; - Symptomatic hearing loss; - Age >70 years. |
Αποτέλεσμα
Πρωτεύοντα αποτελέσματα
1. Primary immunological endpoint: study the use of aspiration fluid from the IP cavity as a biomarker for the efficacy of chemotherapy intervention, measured by decrease in tumor cell count in IP fluid. [Change in tumor cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks]
2. Primary pharmacokinetic endpoint: study pharmacokinetics of cisplatin (platinum unbound fraction) when administered in the IP cavity in plasma and in the peritoneal fluid. [Change in platinum unbound fraction of cisplatin during the first course (first three weeks) of chemotherapy.]
3. Primary pharmacokinetic endpoint: study pharmacokinetics of paclitaxel (plasma concentrations) when administered in the IP cavity in plasma and in the peritoneal fluid. [Change in plasma concentration of paclitaxel during the first course (first three weeks) of chemotherapy.]
Δευτερεύοντα αποτελέσματα
1. Secondary immunological endpoint: rise in dendritic cells [Change in dendritic cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks]
2. Secondary immunological endpoint: rise in tumor infiltrating lymphocytes [Change in lymphocyte cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks]
3. Secondary immunological endpoint: rise in natural killer cells [Change in natural killer cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherpy during 18 weeks]
4. Secondary immunological endpoint: decrease in macrophages M1 type [Change in macrophages M1 type cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks]
5. Secondary immunological endpoint: decrease in macrophages M2 type [Change in macrophages M2 type cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks]
6. Secondary immunological endpoint: change in cytokine level (IL-6) measured by ELISA [Change in IL-6 cytokine levels between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks]
7. Secondary immunological endpoint: change in cytokine level (IL-10) measured by ELISA [Change in IL-10 cytokine levels between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks]
8. Secondary immunological endpoint: change in cytokine level (IFNg) measured by ELISA [Change in IFNg cytokine levels between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks]
9. Secondary immunological endpoint: change in cytokine level (TNFa) measured by ELISA [Change in TNFa cytokine levels between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks]
10. Secondary immunological endpoint: change in cytokine level (CCL2) measured by ELISA [Change in CCL2 cytokine levels between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks]
11. Primary immunological endpoint: study the use of aspiration fluid from the IP cavity as a biomarker for the efficacy of chemotherapy intervention, measured by decrease in pSTAT in IP fluid. [Change in pSTAT between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks]
