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

NCT00527631 | Unknown Phase 1

• 1 other identifier: 176/2005
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer

Keywords

advanced ovarian cancer; whole abdominal irradiation; intensity modulated radiotherapy; ovarian cancer stage FIGO III

Outcome Measures

Primary Outcomes (1)

• feasibility

  8 weeks

Secondary Outcomes (1)

• 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

Interventions

whole abdomen irradiation using IMRT RADIATION

Whole abdomen irradiation as consolidation therapy using intensity modulated radiation therapy (IMRT) to a total dose of 30 Gy in 1.5 Gy fractions

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Department of Radiation Oncology, University of Heidelberg, Im Neuenheimer Feld 400

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Wolfgang Harms, MD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolfgang Harms, MD

CONTACT

+49-6221-568201; wolfgang.harms@med.uni-heidelberg.de

Nathalie Rochet

CONTACT

+49-6221-568201; nathalie.rochet@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2007
• First Posted: September 11, 2007
• Study Start: July 1, 2006
• Study Completion: November 1, 2012
• Last Updated: September 11, 2007

Record last verified: 2007-08

Locations

DE (1)