Phase II study evaluating consolidation whole abdominal intensity-modulated radiotherapy IMRT in patients with advanced ovarian cancer stage FIGO III - The OVAR-IMRT-02 StudyReport as inadecuate




Phase II study evaluating consolidation whole abdominal intensity-modulated radiotherapy IMRT in patients with advanced ovarian cancer stage FIGO III - The OVAR-IMRT-02 Study - Download this document for free, or read online. Document in PDF available to download.

BMC Cancer

, 11:41

First Online: 28 January 2011Received: 18 November 2010Accepted: 28 January 2011DOI: 10.1186-1471-2407-11-41

Cite this article as: Rochet, N., Kieser, M., Sterzing, F. et al. BMC Cancer 2011 11: 41. doi:10.1186-1471-2407-11-41

Abstract

BackgroundThe prognosis for patients with advanced FIGO stage III epithelial ovarian cancer remains poor despite the aggressive standard treatment, consisting of maximal cytoreductive surgery and platinum-based chemotherapy. The median time to recurrence is less than 2 years, with a 5-years survival rate of -20-25%. Recurrences of the disease occur mostly intraperitoneally.

Ovarian cancer is a radiosensitive tumor, so that the use of whole abdominal radiotherapy WAR as a consolidation therapy would appear to be a logical strategy. WAR used to be the standard treatment after surgery before the chemotherapy era; however, it has been almost totally excluded from the treatment of ovarian cancer during the past decade because of its high toxicity. Modern intensity-modulated radiation therapy IMRT has the potential of sparing organs at risk like kidneys, liver, and bone marrow while still adequately covering the peritoneal cavity with a homogenous dose.

Our previous phase I study showed for the first time the clinical feasibility of intensity-modulated WAR and pointed out promising results concerning treatment tolerance. The current phase-II study succeeds to the phase-I study to further evaluate the toxicity of this new treatment.

Methods-designThe OVAR-IMRT-02 study is a single-center one arm phase-II trial. Thirty seven patients with optimally debulked ovarian cancer stage FIGO III having a complete remission after chemotherapy will be treated with intensity-modulated WAR as a consolidation therapy.

A total dose of 30 Gy in 20 fractions of 1.5 Gy will be applied to the entire peritoneal cavity including the liver surface and the pelvic and para-aortic node regions. Organ at risk are kidneys, liver except the 1 cm-outer border, heart, vertebral bodies and pelvic bones.

Primary endpoint is tolerability; secondary objectives are toxicity, quality of life, progression-free and overall survival.

DiscussionIntensity-modulated WAR provides a new promising option in the consolidation treatment of ovarian carcinoma in patients with a complete pathologic remission after adjuvant chemotherapy. Further consequent studies will be needed to enable firm conclusions regarding the value of consolidation radiotherapy within the multimodal treatment of advanced ovarian cancer.

Trial registrationClinicaltrials.gov: NCT01180504

AbbreviationsCRFCase Report Form

CTCAECommon Terminology Criteria for Adverse Events

CTVClinical Target Volume

DMCData Monitoring Committee

FIGOInternational Federation of Gynaecology and Obstetrics

GCPGood Clinical Practice

IMRTIntensity Modulated Radiation Therapy

PTVPlanning Target Volume

TD5-5Tolerance Dose 5% over 5 years

WARWhole-Abdominal Radiotherapy

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Author: Nathalie Rochet - Meinhard Kieser - Florian Sterzing - Sonja Krause - Katja Lindel - Wolfgang Harms - Michael H Eichbaum -

Source: https://link.springer.com/







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