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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

Phase 1
18 Years
75 Years
Open (Enrolling)
Ovarian Cancer

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Trial Information

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

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.

Inclusion Criteria:

- histologically confirmed ovarian cancer stage FIGO III

- grade 2 or 3

- maximal typical surgical resection (including at least total abdominal hysterectomy,
bilateral adnexectomy, omentectomy, debulking of tumour masses)

- postoperative residual tumour of less than 1 cm (maximal diameter of largest tumour
residual is 1 cm)

- adjuvant chemotherapy consisting of six courses of carboplatin/paclitaxel or

- complete remission after chemotherapy

- Karnofsky performance Score >60

- patients > 18 and < 75 years of age

- written informed consent

Exclusion Criteria:

- stage FIGO I or II

- stage IV (distal metastasis)

- stage III R2 > 1 cm

- delayed wound healing post laparotomy

- neutrophil count (ANC) < 2000/ml before radiotherapy

- platelets < 100000/ml

- connective tissue disease, sclerodermia

- clinically active renal, hepatic, cardiac, metabolic, respiratory, coagulation or
haematopoietic disease

- participation in another clinical trial

- patient refusal

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Time Frame:

8 weeks

Principal Investigator

Wolfgang Harms, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Heidelberg


Germany: Ethics Commission

Study ID:




Start Date:

July 2006

Completion Date:

November 2012

Related Keywords:

  • Ovarian Cancer
  • advanced ovarian cancer
  • whole abdominal irradiation
  • intensity modulated radiotherapy
  • ovarian cancer stage FIGO III
  • Ovarian Neoplasms