Consolidation Whole Abdominal Intensity-Modulated Radiation Therapy (IMRT) in Advanced Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The primary objective of this phase-II study is to assess the toxicity of consolidation intensity-modulated whole-abdominal radiotherapy using tomotherapy in patients with advanced optimally debulked stage International Federation of Gynecology and Obstetrics (FIGO) III ovarian cancer with a complete remission after adjuvant chemotherapy. 36 patients will be treated to a total dose of 30 Gy in 1.5 Gy fractions. The planning target-volume includes the entire peritoneal cavity and the pelvic and para-aortal node regions. Intensity-modulated whole-abdominal radiotherapy allows an effective sparing of liver, kidneys and bone-marrow (vertebral bodies and pelvic bones).

Official Title
-----------------
Consolidation Intensity-Modulated Whole Abdominal Radiotherapy for High-Risk Patients With Ovarian Cancer Stage FIGO III

Conditions
-----------------
Ovarian Cancer, Tubal Carcinoma, Primary Peritoneal Carcinoma

Intervention / Treatment
-----------------
* Radiation: intensity-modulated whole-abdominal radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed ovarian cancer or tube cancer or primary peritoneal carcinoma stage FIGO III primary optimal debulking surgery postoperative gross residual tumor ≤ 1cm ( R0, R1 oder R2 < 1cm situation) adjuvant chemotherapy with platin and taxane complete remission after chemotherapy Karnofsky performance score > 60 patients >18 years of age written informed consent Exclusion Criteria: stage FIGO I or II stage III with postoperative gross residual tumor > 1cm stage FIGO IV recurrence situation delayed wound healing post laparotomy leucopenia <2000/ml before radiotherapy thrombocytopenia <75000/ml before radiotherapy clinically active renal, hepatic, cardiac, metabolic, respiratory, coagulation or hematopoietic disease status post pelvic or abdominal radiotherapy status post other cancer disease in the past 5 years (cervical cancer in situ, basal cell carcinoma, squamous cell carcinoma of the skin are excluded) participation in another clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: intensity-modulated whole-abdominal radiotherapy|Consolidation intensity-modulated whole-abdominal radiotherapy using helical tomotherapy to a total dose of 30 Gy in 1.5 Gy fractions|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compatibility of the treatment | Therapy compatibility defined as non-occurrence of life-threatening grade 4 (CTCAE v3.0) acute toxicity | Beginning of radiotherapy till 6 weeks after its completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of incomplete radiotherapy | Rate of incomplete radiotherapy due to treatment toxicity | 4 weeks | 
| Rate of delayed radiotherapy | Rate of delayed radiotherapy due to treatment toxicity | 4 weeks | 
| Acute toxicity | Graded according CTCAE Version 3.0 | From the beginning of radiotherapy till 6 weeks after its completion | 
| Late Toxicity | Graded according CTCAE Version 3.0 | 6 weeks -3 years after the completion of radiotherapy | 
| Overall survival |  | 3 years | 
| Disease-free survival |  | 3 years after the completion of radiotherapy | 
| Quality of life | assessed using EORTC QLQ-C30 Questionnaire | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian cancer, whole-abdominal radiotherapy, consolidation treatment, helical tomotherapy