Consolidation Whole Abdominal Intensity-Modulated Radiation Therapy (IMRT) in Advanced Ovarian Cancer
NCT ID: NCT01180504
Last Updated: 2010-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
36 participants
INTERVENTIONAL
2010-08-31
2016-08-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Deutsche Krebshilfe e.V., Bonn (Germany)
OTHER
University Hospital Heidelberg
OTHER
Responsible Party
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Department of Radiation Oncology, University of Heidelberg
Principal Investigators
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Andreas Schneeweiss, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Gyneacology and Obstetrics, Unversity of Heidelberg
Juergen Debus, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Radiation Oncology, University of Heidelberg
Locations
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Department of Radiation Oncology, University of Heidelberg
Heidelberg, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Rochet N, Sterzing F, Jensen AD, Dinkel J, Herfarth KK, Schubert K, Eichbaum MH, Schneeweiss A, Sohn C, Debus J, Harms W. Intensity-modulated whole abdominal radiotherapy after surgery and carboplatin/taxane chemotherapy for advanced ovarian cancer: phase I study. Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1382-9. doi: 10.1016/j.ijrobp.2009.03.061. Epub 2009 Jul 21.
Arians N, Kieser M, Benner L, Rochet N, Schroder L, Katayama S, Herfarth K, Schubert K, Schneeweiss A, Sohn C, Lindel K, Debus J. Adjuvant intensity modulated whole-abdominal radiation therapy for high-risk patients with ovarian cancer FIGO stage III: final results of a prospective phase 2 study. Radiat Oncol. 2019 Oct 21;14(1):179. doi: 10.1186/s13014-019-1381-2.
Rochet N, Kieser M, Sterzing F, Krause S, Lindel K, Harms W, Eichbaum MH, Schneeweiss A, Sohn C, Debus J. Phase II study evaluating consolidation whole abdominal intensity-modulated radiotherapy (IMRT) in patients with advanced ovarian cancer stage FIGO III--the OVAR-IMRT-02 Study. BMC Cancer. 2011 Jan 28;11:41. doi: 10.1186/1471-2407-11-41.
Other Identifiers
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OVAR-IMRT-02
Identifier Type: -
Identifier Source: org_study_id
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