Status:
UNKNOWN
Consolidation Whole Abdominal Intensity-Modulated Radiation Therapy (IMRT) in Advanced Ovarian Cancer
Lead Sponsor:
University Hospital Heidelberg
Collaborating Sponsors:
Deutsche Krebshilfe e.V., Bonn (Germany)
Conditions:
Ovarian Cancer
Tubal Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01180504
Start Date
August 1 2010
End Date
August 1 2016
Last Update
August 12 2010
Active Locations (1)
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1
Department of Radiation Oncology, University of Heidelberg
Heidelberg, Germany, 69120