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

August 11, 2010 updated by: University Hospital Heidelberg

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • Recruiting
        • Department of Radiation Oncology, University of Heidelberg
        • Principal Investigator:
          • Juergen Debus, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compatibility of the treatment
Time Frame: Beginning of radiotherapy till 6 weeks after its completion
Therapy compatibility defined as non-occurrence of life-threatening grade 4 (CTCAE v3.0) acute toxicity
Beginning of radiotherapy till 6 weeks after its completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years
3 years
Rate of incomplete radiotherapy
Time Frame: 4 weeks
Rate of incomplete radiotherapy due to treatment toxicity
4 weeks
Rate of delayed radiotherapy
Time Frame: 4 weeks
Rate of delayed radiotherapy due to treatment toxicity
4 weeks
Acute toxicity
Time Frame: From the beginning of radiotherapy till 6 weeks after its completion
Graded according CTCAE Version 3.0
From the beginning of radiotherapy till 6 weeks after its completion
Late Toxicity
Time Frame: 6 weeks -3 years after the completion of radiotherapy
Graded according CTCAE Version 3.0
6 weeks -3 years after the completion of radiotherapy
Disease-free survival
Time Frame: 3 years after the completion of radiotherapy
3 years after the completion of radiotherapy
Quality of life
Time Frame: 3 years
assessed using EORTC QLQ-C30 Questionnaire
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

August 11, 2010

First Submitted That Met QC Criteria

August 11, 2010

First Posted (Estimate)

August 12, 2010

Study Record Updates

Last Update Posted (Estimate)

August 12, 2010

Last Update Submitted That Met QC Criteria

August 11, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OVAR-IMRT-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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