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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.
El Hajj, Houssein; Vanseymortier, M; Hudry, D; Bogart, E; Abdeddaim, C; Leblanc, E; Le Deley, M C; Narducci, F.
Afiliação
  • El Hajj H; Gynecologic Oncology Department, Oscar Lambret Cancer Centre, Lille, France. Electronic address: h-elhajj@o-lambret.fr.
  • Vanseymortier M; Clinical Research and Innovation Department, Oscar Lambret Cancer Centre, Lille, France.
  • Hudry D; Gynecologic Oncology Department, Oscar Lambret Cancer Centre, Lille, France.
  • Bogart E; Clinical Research and Innovation Department, Oscar Lambret Cancer Centre, Lille, France.
  • Abdeddaim C; Medical Oncology Department, Oscar Lambret Cancer Center, Lille, France.
  • Leblanc E; Gynecologic Oncology Department, Oscar Lambret Cancer Centre, Lille, France.
  • Le Deley MC; Paris-Saclay University, Paris-Sud University, UVSQ, CESP, INSERM, Villejuif, France.
  • Narducci F; Gynecologic Oncology Department, Oscar Lambret Cancer Centre, Lille, France.
ESMO Open ; 6(2): 100098, 2021 04.
Article em En | MEDLINE | ID: mdl-33819750
ABSTRACT

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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias Ovarianas / Procedimentos Cirúrgicos de Citorredução Tipo de estudo: Clinical_trials / Guideline Aspecto: Patient_preference Limite: Female / Humans Idioma: En Revista: ESMO Open Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias Ovarianas / Procedimentos Cirúrgicos de Citorredução Tipo de estudo: Clinical_trials / Guideline Aspecto: Patient_preference Limite: Female / Humans Idioma: En Revista: ESMO Open Ano de publicação: 2021 Tipo de documento: Article