Adjuvant whole abdominal intensity modulated radiotherapy (IMRT) for high risk stage FIGO III patients with ovarian cancer (OVAR-IMRT-01) – Pilot trial of a phase I/II study: study protocol

Abstract

Background: The prognosis for patients with advanced epithelial ovarian cancer remains poor despite aggressive surgical resection and platinum-based chemotherapy. More than 60% of patients will develop recurrent disease, principally intraperitoneal, and die within 5 years. The use of whole abdominal irradiation (WAI) as consolidation therapy would appear to be a logical strategy given its ability to sterilize small tumour volumes. Despite the clinically proven efficacy of whole abdominal irradiation, the use of radiotherapy in ovarian cancer has profoundly decreased mainly due to high treatment-related toxicity. Modern intensity-modulated radiation therapy (IMRT) could allow to spare kidneys, liver, and bone marrow while still adequately covering the peritoneal cavity with a homogenous dose.

Intensity-Modulated Whole Abdominal Radiotherapy After Surgery and Carboplatin/Taxane Chemotherapy for Advanced Ovarian Cancer: Phase I Study

“…The study protocol was approved by the institutional ethics committee and by an independent expert group of radio-oncologists (29). All patients gave written informed consent before treatment.…”

Image-Guided Whole Abdominal Radiation Therapy in Gynecologic Cancers

“…One phase I/II study has previously investigated the feasibility and safety of using adjuvant IMRT/WART to deliver approximately 30 Gy over 20 daily fractions to the abdominal cavity in high risk patients with stage III ovarian carcinoma [16]. This latter study set out to enroll 8 patients into this treatment regimen.…”

Whole Abdominopelvic Radiotherapy Using Intensity-Modulated Arc Therapy in the Palliative Treatment of Chemotherapy-Resistant Ovarian Cancer With Bulky Peritoneal Disease: A Single-Institution Experience

“…For FIGO Stage III-IV, the survival rate decreases with increasing grade, varying from 38% (Grade 1) to 25% (Grade) and 19% (Grade 3) (6). Failure particularly occurs intraperitoneally and can reach 85% in patients with high-risk features (4,7,8). Secondary cytoreductive surgery is usually insufficient to treat intraperitoneal failure, and second-line chemotherapy has been the treatment of choice at most centers.…”

“…Ovarian cancer still is an important cause of death of women in Western countries (1)(2)(3)(4). Both the International Federation of Gynecology and Obstetrics (FIGO) stage and the histologic grade are important predictors of overall survival (OS) rates at 5 years, varying from 75% (Stage II) to 10% (Stage III-IV) (5,6).…”