Adjuvant Whole Abdominal Intensity Modulated Radiotherapy (IMRT) for High Risk Stage FIGO III Patients With Ovarian Cancer — OVAR-IMRT-01  

Ovarian Cancer Clinical Trial

Official title: Adjuvant Whole Abdominal Intensity Modulated Radiotherapy (IMRT) for High Risk Stage FIGO III Patients With Ovarian Cancer: Pilot Trial of a Phase I/II Study

Status Recruiting

Clinical Trial Summary

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, but despite whole abdominal irradiation has clinically proven efficacy 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.

This study will evaluate feasibility and toxicity of adjuvant consolidation whole abdominal intensity modulated radiotherapy (IMRT) for high risk stage FIGO III patients with ovarian cancer.

Clinical Trial Description

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, but despite whole abdominal irradiation has clinically proven efficacy 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.

The OVAR-IMRT-01 study is a single center pilot trial of a phase I/II study. Patients with advanced ovarian cancer stage FIGO III (R1 or R2< 1cm) after surgical resection and platinum-based chemotherapy will be treated with whole abdomen irradiation as consolidation therapy using intensity modulated radiation therapy (IMRT) to a total dose of 30 Gy in 1.5 Gy fractions. A total of 8 patients will be included in this trial. For treatment planning bone marrow, kidneys, liver, spinal cord, vertebral bodies and pelvic bones are defined as organs at risk. The planning target volume includes the entire peritoneal cavity plus pelvic and para-aortic node regions.

The primary endpoint of the study is the evaluation of the feasibility of intensity-modulated WAI, the secondary endpoint is evaluation of the toxicity of intensity modulated WAI before continuing with the phase I/II study. The aim is to explore the potential of IMRT as a new method for WAI to decrease the dose to kidneys, liver, bone marrow while covering the peritoneal cavity with a homogenous dose, and to implement whole abdominal intensity-modulated radiotherapy into the adjuvant multimodal treatment concept of advanced ovarian cancer FIGO stage III. ;

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

• NCT number: NCT00527631
• Study type: Interventional
• Source: Heidelberg University
• Contact: Wolfgang Harms, MD
• Phone: +49-6221-568201
• Email: wolfgang.harms@med.uni-heidelberg.de
• Status: Recruiting
• Phase: Phase 1
• Start date: July 2006
• Completion date: November 2012