Condition: Metastatic Ovarian Carcinoma · Peritoneal Carcinomatosis · Stage III Ovarian Cancer · Sponsor: Hospices Civils de Lyon
Women with a history of tumor response insufficient to allow complete cytoreductive surgery after three cycles of prior neoadjuvant systemic carboplatin-paclitaxel chemotherapy will be prospectively enrolled in this phase I study. After providing written informed consent and confirmation of unresectable disease by multidisciplinary assessment, patients will undergo three cycles of combined chemotherapy consisting of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with doxorubicin and cisplatin at escalating dose levels, combined with systemic intravenous chemotherapy using carboplatin and paclitaxel at standard doses. Treatment cycles will last 28 days, with PIPAC administered on Day 1 and systemic chemotherapy on Day 8, for a maximum of three cycles in the absence of unacceptable toxicity. Dose escalation of PIPAC chemotherapy will follow a Continual Reassessment Method (CRM) algorithm. The first patient will be treated at the lowest dose level, and subsequent patients will receive the recommended dose according to the CRM, conditional on the occurrence of dose-limiting toxicity (DLT) observed during Cycle 1. From dose level 7 onward, corresponding to cisplatin and doxorubicin doses associated with an increased risk of renal toxicity, sodium thiosulfate will be systematically administered prior to each PIPAC procedure for its nephroprotective effect, in accordance with the cisplatin dose level and current clinical practice. The primary objective of the study is to…
This description comes directly from the study's public registry record.
Justine ARQUILLIERE, MD · 04 78 86 23 71 · justine.arquilliere@chu-lyon.fr
Naoual BAKRIN, MD · 04 78 86 23 71 · naoual.bakrin@chu-lyon.fr
Always discuss trial participation with your own doctor first.
| Hôpital Claude Huriez - Chirurgie générale et digestive | Lille, France | Recruiting |
| Hôpital Claude Huriez - Oncologie médicale | Lille, France | Recruiting |
| Hôpital de la Croix-Rousse | Lyon, France | Recruiting |
| Hôpital Lyon Sud - Chirurgie Digestive et Oncologique | Pierre-Bénite, France | Recruiting |
| Hôpital Lyon Sud - Chirurgie Gynécologique et oncologique-obstétrique | Pierre-Bénite, France | Recruiting |
| Hôpital Lyon Sud - Oncologie Médicale | Pierre-Bénite, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04811703