Titre :

Rationale and study design of the chippi-1808 trial: a phase iii randomized clinical trial evaluating hyperthermic intraperitoneal chemotherapy (hipec) for stage iii ovarian cancer patients treated with primary or interval cytoreductive surgery ^?

Auteur(s) :

El Hajj, H. [Auteur]
Centre Hospitalier Régional Universitaire [CHU Lille] [CHRU Lille]
Vanseymortier, Marie [Auteur]
CIC CHU ( Lille)/inserm
Hudry, D. [Auteur]
CIC CHU ( Lille)/inserm
Bogart, E. [Auteur]
CIC CHU ( Lille)/inserm
Abdeddaim, C. [Auteur]
CIC CHU ( Lille)/inserm
Leblanc, E. [Auteur]
Centre Hospitalier Régional Universitaire [CHU Lille] [CHRU Lille]
Le Deley, M. C. [Auteur]
Centre de recherche en épidémiologie et santé des populations [CESP]
Narducci, Fabrice [Auteur]
Protéomique, Réponse Inflammatoire, Spectrométrie de Masse (PRISM) - U1192

Titre de la revue :

ESMO Open

Nom court de la revue :

ESMO Open

Numéro :

6

Pagination :

100098

Date de publication :

2021-04-02

ISSN :

2059-7029

Mot(s)-clé(s) :

disease-free survival
quality of life
overall survival
HIPEC
ovarian cancer

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

BACKGROUND: Ovarian cancer remains the most lethal gynecologic malignancy with high recurrence rates. Because recurrence involves primarily the peritoneum, intraperitoneal chemotherapy is being evaluated as a new approach ...
Lire la suite >BACKGROUND: Ovarian cancer remains the most lethal gynecologic malignancy with high recurrence rates. Because recurrence involves primarily the peritoneum, intraperitoneal chemotherapy is being evaluated as a new approach to treat microscopic peritoneal disease. One trial showed that cisplatin-paclitaxel intraperitoneal chemotherapy with intravenous paclitaxel improved survival but increased morbidity. Another trial reported a significant improvement in overall survival (OS) and disease-free survival (DFS) without increasing the morbidity (P = 0.76) or mortality rates (hazard ratio 0.67, P = 0.02) after adding hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreduction. The current trial aims to evaluate the impact of adding HIPEC to primary or interval cytoreductive surgery for epithelial ovarian cancer (EOC) on the efficacy, safety, treatment feasibility, and quality of life. PATIENTS AND METHODS: This is an international, multicenter, open-label, randomized (1 : 1), two-arm, phase III clinical trial that will enroll 432 patients with newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage III EOC. Patients are randomized to receive or not HIPEC with the standard of care. Inclusion criteria include patients with FIGO stage III EOC, Fallopian tube carcinoma or primary peritoneal cancer who undergo complete primary or interval cytoreduction. The primary objective is to assess DFS of the addition of HIPEC. Secondary objectives are the assessment of OS, safety, return to intended oncologic treatment, quality of life and the trade-off between efficacy and morbidity. CONCLUSIONS: The results might help extend the indications of HIPEC to include patients undergoing primary cytoreduction, providing a standardized protocol for HIPEC in EOC management and reliable information on the quality of life after adding HIPEC.Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

INSERM
Université de Lille

Collections :

• Protéomique, Réponse Inflammatoire, Spectrométrie de Masse (PRISM) - U1192

Date de dépôt :

2022-06-15T14:00:12Z
2023-03-01T11:38:06Z