Clinical trial NCT01180504: Consolidation Whole Abdominal Intensity-Modulated Radiation Therapy (IMRT) in Advanced Ovarian Cancer
Official title: Consolidation Intensity-Modulated Whole Abdominal Radiotherapy for High-Risk Patients With Ovarian Cancer Stage FIGO III
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Cancer
Tubal Carcinoma
Primary Peritoneal Carcinoma
Keywords: ovarian cancer
whole-abdominal radiotherapy
consolidation treatment
helical tomotherapy
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Deutsche Krebshilfe e.V., Bonn (Germany)
First posted: 2010-08-12
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: compatibility of the treatment
timeFrame: Beginning of radiotherapy till 6 weeks after its completion
Secondary outcomes:
measure: Rate of incomplete radiotherapy
timeFrame: 4 weeks
measure: Rate of delayed radiotherapy
timeFrame: 4 weeks
measure: Acute toxicity
timeFrame: From the beginning of radiotherapy till 6 weeks after its completion
measure: Late Toxicity
timeFrame: 6 weeks -3 years after the completion of radiotherapy
measure: Overall survival
timeFrame: 3 years
measure: Disease-free survival
timeFrame: 3 years after the completion of radiotherapy
measure: Quality of life
timeFrame: 3 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Radiation Oncology, University of Heidelberg
Study officials:
affiliation: Department of Gyneacology and Obstetrics, Unversity of Heidelberg
name: Andreas Schneeweiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Radiation Oncology, University of Heidelberg
name: Juergen Debus, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.