Ovarian CancerPhase 2OVAR-IMRT-02NCT01180504
Consolidation Whole Abdominal Intensity-Modulated Radiation Therapy (IMRT) in Advanced Ovarian Cancer
A Phase 2 study testing intensity-modulated whole-abdominal radiotherapy in people with Ovarian Cancer and Tubal Carcinoma, run by University Hospital Heidelberg at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Tubal Carcinoma, Primary Peritoneal Carcinoma
- What is being tested?
- intensity-modulated whole-abdominal radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, University of Heidelberg
Heidelberg, 69120
Nathalie Rochet, MD, 0049 6221 56 8201, nathalie.rochet@med.uni-heidelberg.de
Juergen Debus, MD, PhD
About this study
Official title: 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).
- Being tested
- intensity-modulated whole-abdominal radiotherapy
- Keywords
- ovarian cancer, whole-abdominal radiotherapy, consolidation treatment, helical tomotherapy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensity-modulated whole-abdominal radiotherapyRadiation
Consolidation intensity-modulated whole-abdominal radiotherapy using helical tomotherapy to a total dose of 30 Gy in 1.5 Gy fractions
What is being measured
The primary outcome is the main question the study is designed to answer.
compatibility of the treatment
Therapy compatibility defined as non-occurrence of life-threatening grade 4 (CTCAE v3.0) acute toxicity
Measured: Beginning of radiotherapy till 6 weeks after its completion
Secondary outcomes (7)
Rate of incomplete radiotherapy
Rate of incomplete radiotherapy due to treatment toxicity
Measured: 4 weeks
Rate of delayed radiotherapy
Rate of delayed radiotherapy due to treatment toxicity
Measured: 4 weeks
Acute toxicity
Graded according CTCAE Version 3.0
Measured: From the beginning of radiotherapy till 6 weeks after its completion
Late Toxicity
Graded according CTCAE Version 3.0
Measured: 6 weeks -3 years after the completion of radiotherapy
Overall survival
Measured: 3 years
Disease-free survival
Measured: 3 years after the completion of radiotherapy
Quality of life
assessed using EORTC QLQ-C30 Questionnaire
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2013 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Investigators
- Andreas Schneeweiss, MD, Principal investigator, Department of Gyneacology and Obstetrics, Unversity of HeidelbergJuergen Debus, MD, PhD, Principal investigator, Department of Radiation Oncology, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180504
- Sponsor's protocol ID
- OVAR-IMRT-02
- Acronym
- OVAR-IMRT-02
- Status last verified
- Aug 2010
- First submitted
- 11 Aug 2010
- Last updated
- 12 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19628341Arians 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.
PubMed 31639066Rochet 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.
PubMed 21276234
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consolidation Intensity-Modulated Whole Abdominal Radiotherapy for High-Risk Patients With Ovarian Cancer Stage FIGO III
- ClinicalTrials.gov ID
- NCT01180504
- Acronym / sponsor ID
- OVAR-IMRT-02 / OVAR-IMRT-02
- Keywords
- ovarian cancer, whole-abdominal radiotherapy, consolidation treatment, helical tomotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 12 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- stage FIGO I or II
- stage III with postoperative gross residual tumor > 1cm
- stage FIGO IV
- recurrence situation
- delayed wound healing post laparotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intensity-modulated whole-abdominal radiotherapyConsolidation intensity-modulated whole-abdominal radiotherapy using helical tomotherapy to a total dose of 30 Gy in 1.5 Gy fractions | Radiation | – |
Primary outcome
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
7 secondary outcomes
Rate of incomplete radiotherapy
Time frame: 4 weeks
Rate of delayed radiotherapy
Time frame: 4 weeks
Acute toxicity
Time frame: From the beginning of radiotherapy till 6 weeks after its completion
Late Toxicity
Time frame: 6 weeks -3 years after the completion of radiotherapy
Overall survival
Time frame: 3 years
Disease-free survival
Time frame: 3 years after the completion of radiotherapy
Quality of life
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2010.
- Background: PubMed 19628341Rochet 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.
- Derived from this study: PubMed 31639066Arians 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.
- Derived from this study: PubMed 21276234Rochet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Schneeweiss, MD principal investigator
Department of Gyneacology and Obstetrics, Unversity of Heidelberg
Juergen Debus, MD, PhD principal investigator
Department of Radiation Oncology, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intensity-modulated whole-abdominal radiotherapy in people with Ovarian Cancer and Tubal Carcinoma, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathalie Rochet, MD (0049 6221 56 8202, nathalie.rochet@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compatibility of the treatment (time frame: Beginning of radiotherapy till 6 weeks after its completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01180504, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2010.