Ovarian CancerPhase 3NCT00170690
Preference Study With Elderly Patients Recurrent Ovarian Cancer
A Phase 3 study testing Treosulfan in people with Ovarian Cancer, run by North Eastern German Society of Gynaecological Oncology at 1 site in Germany.
Trial summary
Comparison of the patient compliance treosulfan oral vs. intravenous (defined as end of therapy for the patient) Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Treosulfan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2004to Apr 2012
- Phase
- Phase 3
- 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 70 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- patient with relapsed ovarian cancer
- study therapy of third regime
- measurable or evaluable tumor lesions or progression defined as CA-125 more than >= 100 U/ ml.
- Age >= 70 years
- ECOG 0-2
- written informed consent
Who cannot join
- Pretreatment with treosulfan
- patient without measurable or evaluable tumor lesions or CA-125 more than >= 100 U/ ml.
- no adequate bone marrow function (leukocyte <= 2,9 x 109/l, platelets <= 100 x 109/ l
- creatinin and bilirubin within >= 1,25 x fold of the reference laboratory´s normal range
- simultaneous radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Präferenz-Studie Bei älteren Patientinnen Mit Ovarialkarzinomrezidiv: Treosulfan Oral vs. intravenös
Comparison of the patient compliance treosulfan oral vs. intravenous (defined as end of therapy for the patient)
Read the detailed description
Approximately 60% of all cancer diseases appear to people aged 65 years and older. Ovarian cancer is the most frequent cause of death among gynaecological malignant tumours. Since the highest carcinoma incidence is between the 60th and 70th year more women will come down with ovarian cancer because of increased life expectancy. At least 65% of patients with FIGO stage III/IV will exhibit a relapse or progress after first-line therapy. In most studies the age of the patients is limited to 65 years. It could be shown that especially elder patients often receive an inadequate operative and cytostatic therapy resulting in a worse prognosis.
Patients aged 70 years or elder who will be treated with treosulfan, given oral or intravenous, shall be compared regarding the patient compliance, toxicity especially hematological and gastrointestinal toxicity grade 3-4 (CTC NCI), overall survival, progression free survival, quality of life.
- Conditions
- Ovarian Cancer
- Being tested
- Treosulfan
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreosulfanDrug
Treosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc
TreosulfanDrug
Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc Receives: Drug: Treosulfan |
| 2 | Experimental | Treosulfan 600 mg/m² p.o. on day 1-28, 57-84, etc Receives: Drug: Treosulfan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of patient´s compliance in both arms defined as therapy break-offs
Measured: during study treatment
Secondary outcomes (1)
Toxicity, overall survival, progression-free survival
Measured: during study treatment and follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionDec 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Eastern German Society of Gynaecological Oncology
- Sponsor type
- University, hospital or other
- Investigators
- Jalid Sehouli, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170690
- Sponsor's protocol ID
- 3401000
- Status last verified
- May 2013
- First submitted
- 12 Sep 2005
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Präferenz-Studie Bei älteren Patientinnen Mit Ovarialkarzinomrezidiv: Treosulfan Oral vs. intravenös
- ClinicalTrials.gov ID
- NCT00170690
- Acronym / sponsor ID
- 3401000
- Conditions
- Ovarian Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- North Eastern German Society of Gynaecological OncologyUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 15 Sep 2005 (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.
Comparison of the patient compliance treosulfan oral vs. intravenous (defined as end of therapy for the patient)
Detailed description
Approximately 60% of all cancer diseases appear to people aged 65 years and older. Ovarian cancer is the most frequent cause of death among gynaecological malignant tumours. Since the highest carcinoma incidence is between the 60th and 70th year more women will come down with ovarian cancer because of increased life expectancy. At least 65% of patients with FIGO stage III/IV will exhibit a relapse or progress after first-line therapy. In most studies the age of the patients is limited to 65 years. It could be shown that especially elder patients often receive an inadequate operative and cytostatic therapy resulting in a worse prognosis.
Patients aged 70 years or elder who will be treated with treosulfan, given oral or intravenous, shall be compared regarding the patient compliance, toxicity especially hematological and gastrointestinal toxicity grade 3-4 (CTC NCI), overall survival, progression free survival, quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TreosulfanTreosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc |
| 2 | Experimental | Drug: TreosulfanTreosulfan 600 mg/m² p.o. on day 1-28, 57-84, etc |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- patient with relapsed ovarian cancer
- study therapy of third regime
- measurable or evaluable tumor lesions or progression defined as CA-125 more than >= 100 U/ ml.
- Age >= 70 years
- ECOG 0-2
Key exclusion criteria (5 listed)
- Pretreatment with treosulfan
- patient without measurable or evaluable tumor lesions or CA-125 more than >= 100 U/ ml.
- no adequate bone marrow function (leukocyte <= 2,9 x 109/l, platelets <= 100 x 109/ l
- creatinin and bilirubin within >= 1,25 x fold of the reference laboratory´s normal range
- simultaneous radiotherapy
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 |
|---|---|---|
| TreosulfanTreosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc | Drug | 2 |
| TreosulfanTreosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc | Drug | 1 |
Primary outcome
Comparison of patient´s compliance in both arms defined as therapy break-offs
Time frame: during study treatment
1 secondary outcome
Toxicity, overall survival, progression-free survival
Time frame: during study treatment and follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
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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.
Jalid Sehouli principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Treosulfan in people with Ovarian Cancer, run by North Eastern German Society of Gynaecological Oncology 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 3 Jun 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of patient´s compliance in both arms defined as therapy break-offs (time frame: during study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2013.