search
Back to results

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

Primary Purpose

Ovarian Cancer, Tubal Carcinoma, Primary Peritoneal Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
intensity-modulated whole-abdominal radiotherapy
Sponsored by
University Hospital Heidelberg
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer, whole-abdominal radiotherapy, consolidation treatment, helical tomotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Radiation Oncology, University of HeidelbergRecruiting

Outcomes

Primary Outcome Measures

compatibility of the treatment
Therapy compatibility defined as non-occurrence of life-threatening grade 4 (CTCAE v3.0) acute toxicity

Secondary Outcome Measures

Rate of incomplete radiotherapy
Rate of incomplete radiotherapy due to treatment toxicity
Rate of delayed radiotherapy
Rate of delayed radiotherapy due to treatment toxicity
Acute toxicity
Graded according CTCAE Version 3.0
Late Toxicity
Graded according CTCAE Version 3.0
Overall survival
Disease-free survival
Quality of life
assessed using EORTC QLQ-C30 Questionnaire

Full Information

First Posted
August 11, 2010
Last Updated
August 11, 2010
Sponsor
University Hospital Heidelberg
Collaborators
Deutsche Krebshilfe e.V., Bonn (Germany)
search

1. Study Identification

Unique Protocol Identification Number
NCT01180504
Brief Title
Consolidation Whole Abdominal Intensity-Modulated Radiation Therapy (IMRT) in Advanced Ovarian Cancer
Acronym
OVAR-IMRT-02
Official Title
Consolidation Intensity-Modulated Whole Abdominal Radiotherapy for High-Risk Patients With Ovarian Cancer Stage FIGO III
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Heidelberg
Collaborators
Deutsche Krebshilfe e.V., Bonn (Germany)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Tubal Carcinoma, Primary Peritoneal Carcinoma
Keywords
ovarian cancer, whole-abdominal radiotherapy, consolidation treatment, helical tomotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
intensity-modulated whole-abdominal radiotherapy
Intervention Description
Consolidation intensity-modulated whole-abdominal radiotherapy using helical tomotherapy to a total dose of 30 Gy in 1.5 Gy fractions
Primary Outcome Measure Information:
Title
compatibility of the treatment
Description
Therapy compatibility defined as non-occurrence of life-threatening grade 4 (CTCAE v3.0) acute toxicity
Time Frame
Beginning of radiotherapy till 6 weeks after its completion
Secondary Outcome Measure Information:
Title
Rate of incomplete radiotherapy
Description
Rate of incomplete radiotherapy due to treatment toxicity
Time Frame
4 weeks
Title
Rate of delayed radiotherapy
Description
Rate of delayed radiotherapy due to treatment toxicity
Time Frame
4 weeks
Title
Acute toxicity
Description
Graded according CTCAE Version 3.0
Time Frame
From the beginning of radiotherapy till 6 weeks after its completion
Title
Late Toxicity
Description
Graded according CTCAE Version 3.0
Time Frame
6 weeks -3 years after the completion of radiotherapy
Title
Overall survival
Time Frame
3 years
Title
Disease-free survival
Time Frame
3 years after the completion of radiotherapy
Title
Quality of life
Description
assessed using EORTC QLQ-C30 Questionnaire
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie Rochet, MD
Phone
0049 6221 56 8202
Email
nathalie.rochet@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Schneeweiss, MD
Organizational Affiliation
Department of Gyneacology and Obstetrics, Unversity of Heidelberg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juergen Debus, MD, PhD
Organizational Affiliation
Department of Radiation Oncology, University of Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiation Oncology, University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Rochet, MD
Phone
0049 6221 56 8201
Email
nathalie.rochet@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Juergen Debus, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19628341
Citation
Rochet N, Sterzing F, Jensen AD, Dinkel J, Herfarth KK, Schubert K, Eichbaum MH, Schneeweiss A, Sohn C, Debus J, Harms W. Intensity-modulated whole abdominal radiotherapy after surgery and carboplatin/taxane chemotherapy for advanced ovarian cancer: phase I study. Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1382-9. doi: 10.1016/j.ijrobp.2009.03.061. Epub 2009 Jul 21.
Results Reference
background
PubMed Identifier
31639066
Citation
Arians N, Kieser M, Benner L, Rochet N, Schroder L, Katayama S, Herfarth K, Schubert K, Schneeweiss A, Sohn C, Lindel K, Debus J. Adjuvant intensity modulated whole-abdominal radiation therapy for high-risk patients with ovarian cancer FIGO stage III: final results of a prospective phase 2 study. Radiat Oncol. 2019 Oct 21;14(1):179. doi: 10.1186/s13014-019-1381-2.
Results Reference
derived
PubMed Identifier
21276234
Citation
Rochet N, Kieser M, Sterzing F, Krause S, Lindel K, Harms W, Eichbaum MH, Schneeweiss A, Sohn C, Debus J. Phase II study evaluating consolidation whole abdominal intensity-modulated radiotherapy (IMRT) in patients with advanced ovarian cancer stage FIGO III--the OVAR-IMRT-02 Study. BMC Cancer. 2011 Jan 28;11:41. doi: 10.1186/1471-2407-11-41.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs