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

This study is currently recruiting participants. (see Contacts and Locations)
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

August 11, 2010
August 11, 2010
August 2010
August 2013   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Consolidation Whole Abdominal Intensity-Modulated Radiation Therapy (IMRT) in Advanced Ovarian Cancer
Consolidation Intensity-Modulated Whole Abdominal Radiotherapy for High-Risk Patients With Ovarian Cancer Stage FIGO III

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).

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Cancer
  • Tubal Carcinoma
  • Primary Peritoneal Carcinoma
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
August 2016
August 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Nathalie Rochet, MD 0049 6221 56 8202 nathalie.rochet@med.uni-heidelberg.de
Germany
 
NCT01180504
OVAR-IMRT-02
Yes
Juergen Debus / Prof., M.D., PhD, Department of Radiation Oncology, University of Heidelberg
University Hospital Heidelberg
Deutsche Krebshilfe e.V., Bonn (Germany)
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
University Hospital Heidelberg
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP