title: 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.
abstract: BACKGROUND
  The 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
  The 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.
  
  
  CONCLUSIONS
  Intensity-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.
  
  
  BACKGROUND
  Clinicaltrials.gov: NCT01180504.
authors.affiliation: Department of Radiation Oncology, University of Heidelberg, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany. nathalie.rochet@med.uni-heidelberg.de
authors.forename: Nathalie
authors.initials: N
authors.lastname: Rochet
authors.forename: Meinhard
authors.initials: M
authors.lastname: Kieser
authors.forename: Florian
authors.initials: F
authors.lastname: Sterzing
authors.forename: Sonja
authors.initials: S
authors.lastname: Krause
authors.forename: Katja
authors.initials: K
authors.lastname: Lindel
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Harms
authors.forename: Michael H
authors.initials: MH
authors.lastname: Eichbaum
authors.forename: Andreas
authors.initials: A
authors.lastname: Schneeweiss
authors.forename: Christof
authors.initials: C
authors.lastname: Sohn
authors.forename: Juergen
authors.initials: J
authors.lastname: Debus
mesh_terms: D000005:Abdomen / Q000528:radiation effects; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002277:Carcinoma / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy*; D018450:Disease Progression; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy*; D018714:Radiotherapy, Adjuvant / Q000379:methods; D050397:Radiotherapy, Intensity-Modulated / Q000379:methods*; D012074:Remission Induction / Q000379:methods