Consolidation Whole Abdominal Intensity-Modulated Radiation Therapy (IMRT) in Advanced Ovarian Cancer

Phase 2

• Conditions: Ovarian Cancer; Tubal Carcinoma; Primary Peritoneal Carcinoma

• Registration Number: NCT01180504
• Lead Sponsor: University Hospital Heidelberg

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-08
• Study Start: 2010-08
• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-08-11
• Last Update Submitted: 2010-08-11
• Study First Posted: 2010-08-12
• Last Update Posted: 2010-08-12
• Primary Completion: 2013-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Rate of incomplete radiotherapy	4 weeks	Rate of incomplete radiotherapy due to treatment toxicity
Overall survival	3 years
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
Late Toxicity	6 weeks -3 years after the completion of radiotherapy	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

Trial Locations

Locations (1)

Department of Radiation Oncology, University of Heidelberg; 🇩🇪 Heidelberg, Germany