NCT04811703Toboroz1. fázis
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Associated With Systemic Chemotherapy in Women With Advanced Ovarian Cancer
Phase I Dose Escalation Study Evaluating the Safety of Adding Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin-doxorubicin to the Systemic Chemotherapy, and the Recommended Phase II Dose, in Women With Insufficient Response to Carboplatin-paclitaxel for Advanced Epithelial Cancer of the Ovary, Fallopian Tubes or Peritoneum
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 6.
Rövid összefoglaló (regiszter, angolul)
Women with history of tumor response insufficient to allow complete cytoreductive surgery after three cycles of previous neoadjuvant systemic carboplatin-paclitaxel chemotherapy will be prospectively recruited in this trial. After signed consent and if unresectability is confirmed, patients will undergo three cycles of doxorubicin-cisplatin PIPAC chemotherapy associated with systemic carboplatin-paclitaxel chemotherapy (alternating PIPAC and intravenous chemotherapy sessions over 3 cycles of 4 weeks). Since the 7th amendment of the study, sodium thiosulfate as nephrtoxicity prevention has been administered concurrently with each PIPAC chemotherapy The primary objective of the study is to determine the maximum tolerated dose (MDT). During cycle 1, limiting dose toxicity must be collected as soon as it is known. Each patients will be treated at the dose recommended by the CRM (Continual Reassessment Method ) algorithm conditional on dose-limiting toxicity during Cycle 1. The dose escalation will be guided by CRM to determine the recommended dose of PIPAC chemotherapy for phase II trial. Secondary objectives are : * to evaluate the anatomopathological response, the radiologic tumoral response and the evolution of the peritoneal cancer extent, to the combined chemotherapy * to describe the pharmacokinetic of the PIPAC chemotherapy * to investigate the KELIM parameter as a predictive marker in the response sensitivity of the combined chemotherapy treatment * and to evaluate the safety of the combined chemotherapy. During the first day of the first cycle, blood samples will be collected to measure doxorubicin and cisplatin (pharmacokinetic study). Along these 3 cycles, the dose of antigen CA-125 will be performed before each chemotherapies (intraperitoneal or intravenous). Following the addition of sodium thiosulfate to the treatment regimen, an exploratory objective was added to assess its nephroprotective effects At the end of combined chemotherapy treatment, patients will undergo radiologic tumoral response by imaging assessment (scanner or MRI) and a last dosage of CA-125 will be realized.. In case of a complete / partial response / stabilization (RECIST criteria v.1.) on the imaging, re-evaluation for resectability will be done. If resectable disease, cytoreductive surgery will be programmed and a post-operative visit 1 month later will be realized. Otherwise for patients with progress disease or unresectable the participation in the study will be finished.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 15 (tervezett)
- Első benyújtás
- 2021. márc. 8.
- Kezdés
- 2021. júl. 30.
- Elsődleges befejezés
- 2028. jún.
- Fő szponzor
- Hospices Civils de Lyon
- Betegségek
- Petefészekrák
- NCT-szám
- NCT04811703
- EU CT-szám
- 2024-515996-37-00
- EudraCT-szám
- 2021-000831-30
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Tervezett résztvevők: 15
- 2021. júl. 30. és az elsődleges befejezés (2028. jún.) között
- 3 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Extra-peritoneal metastases whose location or extent precludes a potentially curative surgical procedure;
- Administration of a live attenuated vaccine within 3 months prior to study treatment initiation or planned during the study;
Más betegség
- Signs of bowel obstruction, bowel lesions with a high risk of intestinal perforation based on their location, or evidence of inflammatory bowel disease;
- Contraindication to intravenous carboplatin-paclitaxel chemotherapy, including known severe hypersensitivity to paclitaxel;
- Contraindication to PIPAC procedures, including:
- Known hypersensitivity to cisplatin or other platinum compounds;
- Known hypersensitivity to doxorubicin or other anthracyclines or anthracenediones;
- Cardiac disease with myocardial insufficiency;
- Uncontrolled coronary artery disease;
Laborértékek
- Known hypersensitivity to sodium thiosulfate, sulfites, or any of its excipients;
Egyéb
- Pregnant or breastfeeding women;
- Individuals deprived of liberty, under guardianship, or subject to legal protection measures;
- Participation in another interventional research study with an ongoing exclusion period at inclusion, or in a study that could interfere with the results of the present study, as judged by the investigator;
- Inability to comply with study follow-up for geographical, social, or psychological reasons, as judged by the investigator.
Kiket keres a vizsgálat
- Age ≥ 18 years and ≤ 75 years;
- ECOG Performance Status 0-2;
- Histologically confirmed epithelial carcinoma of the ovary, fallopian tubes, or peritoneum, FIGO stage IIb to IVa, with a tumor response after three cycles of carboplatin-paclitaxel that does not correspond to disease progression but is insufficient to allow complete cytoreductive surgery, as assessed by the investigators after multidisciplinary tumor board discussion and validation;
- Adequate hematological function:
- Absolute neutrophil count > 1,500/mm³ (or 1.5 × 10⁹/L);
- Hemoglobin ≥ 9.0 g/dL;
- Platelet count > 100 × 10⁹/L;
- Adequate renal and hepatic function:
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or estimated glomerular filtration rate ≥ 60 mL/min/1.73 m² (CKD-EPI equation);
- Total bilirubin ≤ 1.5 × ULN;
- AST and ALT ≤ 1.5 × ULN (≤ 5 × ULN in patients with liver metastases);
- No unstable medical conditions, including myocardial infarction within 6 months prior to study entry, congestive heart failure, unstable angina, active cardiomyopathy, unstable arrhythmia, uncontrolled hypertension, uncontrolled psychiatric disorders, severe infection, peptic ulcer disease, or any condition that could be worsened by the study treatment or impair compliance, as judged by the investigator;
- Written informed consent obtained prior to any study-specific procedures;
- Patient affiliated with a national health insurance system.
Életkor a regiszterben: 18 év – 75 év · Nem: csak nők · Egészséges önkénteseket nem fogad
Helyszínek (3)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Centre Hospitalier Universitaire De Lille | Lille Cedex | Franciaország | Toboroz |
| Hospices Civils De Lyon | Lyon Cedex 04 | Franciaország | Toboroz |
| Hospices Civils de Lyon | Pierre-Bénite | Franciaország | Toboroz |
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