Ovarian Cancer
Conditions
Keywords
advanced ovarian cancer, whole abdominal irradiation, intensity modulated radiotherapy, ovarian cancer stage FIGO III
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.
Interventions
RADIATIONwhole abdomen irradiation using IMRT
Whole abdomen irradiation as consolidation therapy using intensity modulated radiation therapy (IMRT) to a total dose of 30 Gy in 1.5 Gy fractions
Sponsors
Heidelberg University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| feasibility | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| toxicity | 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 |
Countries
Germany
Contacts
Primary ContactWolfgang Harms, MD
Backup ContactNathalie Rochet
Outcome results
None listed