Ovarian Cancer, Primary Peritoneal Carcinoma, Tubal Carcinoma
Conditions
Keywords
ovarian cancer, whole-abdominal radiotherapy, consolidation treatment, helical tomotherapy
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).
Interventions
RADIATIONintensity-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
Sponsors
Deutsche Krebshilfe e.V., Bonn (Germany)
University Hospital Heidelberg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| compatibility of the treatment | Beginning of radiotherapy till 6 weeks after its completion | Therapy compatibility defined as non-occurrence of life-threatening grade 4 (CTCAE v3.0) acute toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of incomplete radiotherapy | 4 weeks | Rate of incomplete radiotherapy due to treatment toxicity |
| Rate of delayed radiotherapy | 4 weeks | Rate of delayed radiotherapy due to treatment toxicity |
| Acute toxicity | From the beginning of radiotherapy till 6 weeks after its completion | Graded according CTCAE Version 3.0 |
| Disease-free survival | 3 years after the completion of radiotherapy | — |
| Quality of life | 3 years | assessed using EORTC QLQ-C30 Questionnaire |
| Late Toxicity | 6 weeks -3 years after the completion of radiotherapy | Graded according CTCAE Version 3.0 |
| Overall survival | 3 years | — |
Countries
Germany
Contacts
Primary ContactNathalie Rochet, MD
Outcome results
None listed