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

Ovarian Cancer Clinical Trial

— OVAR-IMRT-02  

Official title:

Consolidation Intensity-Modulated Whole Abdominal Radiotherapy for High-Risk Patients With Ovarian Cancer Stage FIGO III

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01180504
• Other study ID #: OVAR-IMRT-02
• Status: Recruiting
• Phase: Phase 2
• First received: August 11, 2010
• Last updated: August 11, 2010
• Start date: August 2010
• Est. completion date: August 2016

Study information

• Verified date: August 2010
• Source: University Hospital Heidelberg
• Contact: Nathalie Rochet, MD
• Phone: 0049 6221 56 8202
• Email: nathalie.rochet[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Office for Radiation ProtectionGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: August 2016
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Ovarian Cancer
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma
• Tubal Carcinoma

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
Germany	Department of Radiation Oncology, University of Heidelberg	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Heidelberg	Deutsche Krebshilfe e.V., Bonn (Germany)

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Rate of incomplete radiotherapy	Rate of incomplete radiotherapy due to treatment toxicity	4 weeks	Yes
Secondary	Rate of delayed radiotherapy	Rate of delayed radiotherapy due to treatment toxicity	4 weeks	Yes
Secondary	Acute toxicity	Graded according CTCAE Version 3.0	From the beginning of radiotherapy till 6 weeks after its completion	Yes
Secondary	Late Toxicity	Graded according CTCAE Version 3.0	6 weeks -3 years after the completion of radiotherapy	Yes
Secondary	Overall survival		3 years	No
Secondary	Disease-free survival		3 years after the completion of radiotherapy	No
Secondary	Quality of life	assessed using EORTC QLQ-C30 Questionnaire	3 years	Yes