Hodgkins LymphomaPhase 2PROFENCT01014507
Protection of Ovarian Function in Female Patients With Hodgkin Lymphoma
A Phase 2 study testing 8 cycles BEACOPPesc plus oral contraceptive and 8 cycles BEACOPPesc plus Goserelin in people with Hodgkins Lymphoma, run by University of Cologne.
Trial summary
This study is designed to test the the protective capacity of Goserelin compared with oral contraceptive Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hodgkins Lymphoma
- What is being tested?
- 8 cycles BEACOPPesc plus oral contraceptive and 8 cycles BEACOPPesc plus Goserelin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Sep 2009
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Advanced stage Hodgkins Lymphoma (histologically proven)
- Normal FSH-levels
- Written informed consent
Who cannot join
- Hodgkins Lymphoma as "composite lymphoma"
- Primary ovarial dysfunction
- Age > 40
About this study
Official title: Randomisierte Phase II Studie Zum Einsatz Von Goserelin Und Oralen Kontrazeptiva Zur Reduktion Ovarieller Toxizitäten während Zytostatischer Primärtherapie Bei Fertilen Patientinnen Mit Hodgkin Lymphom in Fortgeschrittenen Stadien
This study is designed to test the the protective capacity of Goserelin compared with oral contraceptive
- Conditions
- Hodgkins Lymphoma
- Being tested
- 8 cycles BEACOPPesc plus oral contraceptive, 8 cycles BEACOPPesc plus Goserelin
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8 cycles BEACOPPesc plus oral contraceptiveDrug
8 cycles BEACOPPesc plus GoserelinDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: 8 cycles BEACOPPesc plus oral contraceptive |
| B | Experimental | Not described Receives: Drug: 8 cycles BEACOPPesc plus Goserelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
FSH level 6 month after end of treatment
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startJan 2004
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hodgkins LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014507
- Sponsor's protocol ID
- PROFE
- Acronym
- PROFE
- Status last verified
- Oct 2011
- First submitted
- 16 Nov 2009
- Last updated
- 25 Jun 2012
- Results posted
- No
Publications
Behringer K, Wildt L, Mueller H, Mattle V, Ganitis P, van den Hoonaard B, Ott HW, Hofer S, Pluetschow A, Diehl V, Engert A, Borchmann P; German Hodgkin Study Group. No protection of the ovarian follicle pool with the use of GnRH-analogues or oral contraceptives in young women treated with escalated BEACOPP for advanced-stage Hodgkin lymphoma. Final results of a phase II trial from the German Hodgkin Study Group. Ann Oncol. 2010 Oct;21(10):2052-2060. doi: 10.1093/annonc/mdq066. Epub 2010 Mar 19.
PubMed 20305034
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomisierte Phase II Studie Zum Einsatz Von Goserelin Und Oralen Kontrazeptiva Zur Reduktion Ovarieller Toxizitäten während Zytostatischer Primärtherapie Bei Fertilen Patientinnen Mit Hodgkin Lymphom in Fortgeschrittenen Stadien
- ClinicalTrials.gov ID
- NCT01014507
- Acronym / sponsor ID
- PROFE / PROFE
- Conditions
- Hodgkins Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Nov 2009 (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.
This study is designed to test the the protective capacity of Goserelin compared with oral contraceptive
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: 8 cycles BEACOPPesc plus oral contraceptive |
| B | Experimental | Drug: 8 cycles BEACOPPesc plus Goserelin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Advanced stage Hodgkins Lymphoma (histologically proven)
- Normal FSH-levels
- Written informed consent
Key exclusion criteria (3 listed)
- Hodgkins Lymphoma as "composite lymphoma"
- Primary ovarial dysfunction
- Age > 40
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 |
|---|---|---|
| 8 cycles BEACOPPesc plus oral contraceptive | Drug | A |
| 8 cycles BEACOPPesc plus Goserelin | Drug | B |
Primary outcome
FSH level 6 month after end of treatment
Time frame: 6 month
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 25 Jun 2012.
- Results publication: PubMed 20305034Behringer K, Wildt L, Mueller H, Mattle V, Ganitis P, van den Hoonaard B, Ott HW, Hofer S, Pluetschow A, Diehl V, Engert A, Borchmann P; German Hodgkin Study Group. No protection of the ovarian follicle pool with the use of GnRH-analogues or oral contraceptives in young women treated with escalated BEACOPP for advanced-stage Hodgkin lymphoma. Final results of a phase II trial from the German Hodgkin Study Group. Ann Oncol. 2010 Oct;21(10):2052-2060. doi: 10.1093/annonc/mdq066. Epub 2010 Mar 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 8 cycles BEACOPPesc plus oral contraceptive and 8 cycles BEACOPPesc plus Goserelin in people with Hodgkins Lymphoma, run by University of Cologne.
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 3 inclusion and 3 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 25 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
FSH level 6 month after end of treatment (time frame: 6 month). 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 NCT01014507, which also lists 1 linked publication.
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 25 Jun 2012.