Clinical trial NCT00527631: Adjuvant Whole Abdominal Intensity Modulated Radiotherapy (IMRT) for High Risk Stage FIGO III Patients With Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Ovarian Cancer
Keywords: advanced ovarian cancer
whole abdominal irradiation
intensity modulated radiotherapy
ovarian cancer stage FIGO III
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2007-09-11
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 carboplatin/docetaxel
* 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

Primary outcomes:
measure: feasibility
timeFrame: 8 weeks
Secondary outcomes:
measure: toxicity
timeFrame: baseline, weekly during the 4 weeks of radiation. Follow up 6 weeks, 3 months, 6 months, 9 months, 12 months post treatment, and then every 6 months for 5 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Radiation Oncology, University of Heidelberg, Im Neuenheimer Feld 400
Study officials:
affiliation: Heidelberg University
name: Wolfgang Harms, MD
role: PRINCIPAL_INVESTIGATOR
References: