Adjuvant Whole Abdominal Intensity Modulated Radiotherapy (IMRT) for High Risk Stage FIGO III Patients With Ovarian Cancer

Ovarian Cancer Clinical Trial

— OVAR-IMRT-01  

Official title:

Adjuvant Whole Abdominal Intensity Modulated Radiotherapy (IMRT) for High Risk Stage FIGO III Patients With Ovarian Cancer: Pilot Trial of a Phase I/II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00527631
• Other study ID #: 176/2005
• Status: Recruiting
• Phase: Phase 1
• First received: September 7, 2007
• Last updated: September 7, 2007
• Start date: July 2006
• Est. completion date: November 2012

Study information

• Verified date: August 2007
• Source: Heidelberg University
• Contact: Wolfgang Harms, MD
• Phone: +49-6221-568201
• Email: wolfgang.harms[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The prognosis for patients with advanced epithelial ovarian cancer remains poor despite aggressive surgical resection and platinum-based chemotherapy. More than 60% of patients will develop recurrent disease, principally intraperitoneal, and die within 5 years. The use of whole abdominal irradiation (WAI) as consolidation therapy would appear to be a logical strategy, but despite whole abdominal irradiation has clinically proven efficacy the use of radiotherapy in ovarian cancer has profoundly decreased mainly due to high treatment-related toxicity. Modern intensity-modulated radiation therapy (IMRT) could allow to spare kidneys, liver, and bone marrow while still adequately covering the peritoneal cavity with a homogenous dose.

This study will evaluate feasibility and toxicity of adjuvant consolidation whole abdominal intensity modulated radiotherapy (IMRT) for high risk stage FIGO III patients with ovarian cancer.

Description:

The prognosis for patients with advanced epithelial ovarian cancer remains poor despite aggressive surgical resection and platinum-based chemotherapy. More than 60% of patients will develop recurrent disease, principally intraperitoneal, and die within 5 years. The use of whole abdominal irradiation (WAI) as consolidation therapy would appear to be a logical strategy, but despite whole abdominal irradiation has clinically proven efficacy the use of radiotherapy in ovarian cancer has profoundly decreased mainly due to high treatment-related toxicity. Modern intensity-modulated radiation therapy (IMRT) could allow to spare kidneys, liver, and bone marrow while still adequately covering the peritoneal cavity with a homogenous dose.

The OVAR-IMRT-01 study is a single center pilot trial of a phase I/II study. Patients with advanced ovarian cancer stage FIGO III (R1 or R2< 1cm) after surgical resection and platinum-based chemotherapy will be treated with whole abdomen irradiation as consolidation therapy using intensity modulated radiation therapy (IMRT) to a total dose of 30 Gy in 1.5 Gy fractions. A total of 8 patients will be included in this trial. For treatment planning bone marrow, kidneys, liver, spinal cord, vertebral bodies and pelvic bones are defined as organs at risk. The planning target volume includes the entire peritoneal cavity plus pelvic and para-aortic node regions.

The primary endpoint of the study is the evaluation of the feasibility of intensity-modulated WAI, the secondary endpoint is evaluation of the toxicity of intensity modulated WAI before continuing with the phase I/II study. The aim is to explore the potential of IMRT as a new method for WAI to decrease the dose to kidneys, liver, bone marrow while covering the peritoneal cavity with a homogenous dose, and to implement whole abdominal intensity-modulated radiotherapy into the adjuvant multimodal treatment concept of advanced ovarian cancer FIGO stage III.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• histologically confirmed ovarian cancer stage FIGO III

• grade 2 or 3

• maximal typical surgical resection (including at least total abdominal hysterectomy, bilateral adnexectomy, omentectomy, debulking of tumour masses)

• postoperative residual tumour of less than 1 cm (maximal diameter of largest tumour residual is 1 cm)

• adjuvant chemotherapy consisting of six courses of carboplatin/paclitaxel or carboplatin/docetaxel

• complete remission after chemotherapy

• Karnofsky performance Score >60

• patients > 18 and < 75 years of age

• written informed consent

Exclusion Criteria:

• stage FIGO I or II

• stage IV (distal metastasis)

• stage III R2 > 1 cm

• delayed wound healing post laparotomy

• neutrophil count (ANC) < 2000/ml before radiotherapy

• platelets < 100000/ml

• connective tissue disease, sclerodermia

• clinically active renal, hepatic, cardiac, metabolic, respiratory, coagulation or haematopoietic disease

• participation in another clinical trial

• patient refusal

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Radiation:
• whole abdomen irradiation using IMRT
Whole abdomen irradiation as consolidation therapy using intensity modulated radiation therapy (IMRT) 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, Im Neuenheimer Feld 400	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility		8 weeks
Secondary	toxicity		baseline, weekly during the 4 weeks of radiation. Follow up 6 weeks, 3 months, 6 months, 9 months, 12 months post treatment, and then every 6 months for 5 years