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| Name | Class |
|---|---|
| Deutsche Krebshilfe e.V., Bonn (Germany) | OTHER |
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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensity-modulated whole-abdominal radiotherapy | Radiation | Consolidation intensity-modulated whole-abdominal radiotherapy using helical tomotherapy to a total dose of 30 Gy in 1.5 Gy fractions |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathalie Rochet, MD | Contact | 0049 6221 56 8202 | nathalie.rochet@med.uni-heidelberg.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Schneeweiss, MD | Department of Gyneacology and Obstetrics, Unversity of Heidelberg | Principal Investigator |
| Juergen Debus, MD, PhD | Department of Radiation Oncology, University of Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, University of Heidelberg | Recruiting | Heidelberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19628341 | Background | 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. | |
| 31639066 |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| 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 |
| Derived |
| 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. |
| 21276234 | Derived | 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. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |