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Consolidation Whole Abdominal Intensity-Modulated Radiation Therapy (IMRT) in Advanced Ovarian Cancer (OVAR-IMRT-02)

This study is currently recruiting participants.
Verified August 2010 by University Hospital Heidelberg
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by:
University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01180504
First received: August 11, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Ovarian Cancer
Tubal Carcinoma
Primary Peritoneal Carcinoma
 Radiation: intensity-modulated whole-abdominal radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Consolidation Intensity-Modulated Whole Abdominal Radiotherapy for High-Risk Patients With Ovarian Cancer Stage FIGO III

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • compatibility of the treatment [ Time Frame: Beginning of radiotherapy till 6 weeks after its completion ] [ Designated as safety issue: Yes ]
    Therapy compatibility defined as non-occurrence of life-threatening grade 4 (CTCAE v3.0) acute toxicity


Secondary Outcome Measures:
  • Rate of incomplete radiotherapy [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Rate of incomplete radiotherapy due to treatment toxicity

  • Rate of delayed radiotherapy [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Rate of delayed radiotherapy due to treatment toxicity

  • Acute toxicity [ Time Frame: From the beginning of radiotherapy till 6 weeks after its completion ] [ Designated as safety issue: Yes ]
    Graded according CTCAE Version 3.0

  • Late Toxicity [ Time Frame: 6 weeks -3 years after the completion of radiotherapy ] [ Designated as safety issue: Yes ]
    Graded according CTCAE Version 3.0

  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: 3 years after the completion of radiotherapy ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    assessed using EORTC QLQ-C30 Questionnaire


Estimated Enrollment: 36
Study Start Date: August 2010
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180504

Contacts
Contact: Nathalie Rochet, MD 0049 6221 56 8202 nathalie.rochet@med.uni-heidelberg.de

Locations
Germany
Department of Radiation Oncology, University of Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Nathalie Rochet, MD     0049 6221 56 8201     nathalie.rochet@med.uni-heidelberg.de    
Principal Investigator: Juergen Debus, MD, PhD            
Sponsors and Collaborators
University Hospital Heidelberg
Deutsche Krebshilfe e.V., Bonn (Germany)
Investigators
Principal Investigator: Andreas Schneeweiss, MD Department of Gyneacology and Obstetrics, Unversity of Heidelberg
Principal Investigator: Juergen Debus, MD, PhD Department of Radiation Oncology, University of Heidelberg
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Juergen Debus / Prof., M.D., PhD, Department of Radiation Oncology, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01180504     History of Changes
Other Study ID Numbers: OVAR-IMRT-02
Study First Received: August 11, 2010
Last Updated: August 11, 2010
Health Authority: Germany: Federal Office for Radiation Protection
Germany: Ethics Commission

Keywords provided by University Hospital Heidelberg:
ovarian cancer
whole-abdominal radiotherapy
consolidation treatment
helical tomotherapy

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
 Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on May 21, 2013