Adjuvant Whole Abdominal Intensity Modulated Radiotherapy (IMRT) for High Risk Stage FIGO III Patients With Ovarian Cancer (OVAR-IMRT-01)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Heidelberg University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00527631
First received: September 7, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Radiation: whole abdomen irradiation using IMRT
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • feasibility [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • toxicity [ Time Frame: 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 ]

Estimated Enrollment: 8
Study Start Date: July 2006
Estimated Study Completion Date: November 2012
Intervention Details:
    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
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527631

Contacts
Contact: Wolfgang Harms, MD +49-6221-568201 wolfgang.harms@med.uni-heidelberg.de
Contact: Nathalie Rochet +49-6221-568201 nathalie.rochet@med.uni-heidelberg.de

Locations
Germany
Department of Radiation Oncology, University of Heidelberg, Im Neuenheimer Feld 400 Recruiting
Heidelberg, Germany, 69120
Contact: Nathalie Rochet    +49-6221-568201    nathalie.rochet@med.uni-heidelberg.de   
Principal Investigator: Wolfgang Harms, MD         
Sub-Investigator: Nathalie Rochet         
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Wolfgang Harms, MD Heidelberg University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00527631     History of Changes
Other Study ID Numbers: 176/2005
Study First Received: September 7, 2007
Last Updated: September 7, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by Heidelberg University:
advanced ovarian cancer
whole abdominal irradiation
intensity modulated radiotherapy
ovarian cancer stage FIGO III

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 20, 2014