Fallopian Tube CancerPhase 3NCT00002895
Early Chemotherapy Based on CA 125 Level Alone Compared With Delayed Chemotherapy in Treating Patients With Recurrent Ovarian Epithelial , Fallopian Tube, or Primary Peritoneal Cancer
A Phase 3 study testing chemotherapy in people with Fallopian Tube Cancer and Ovarian Cancer, run by Medical Research Council at 21 sites in 10 countries.
Trial summary
RATIONALE: It is not yet known if treatment for recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer is more effective if it is begun when blood levels of CA 125 become elevated rather than waiting for other indicators of disease recurrence. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- What is being tested?
- chemotherapy
- How many people
- 1,400 participants
- Where
- 21 sitesin 10 countries
- Study dates
- Jun 1996to Oct 2010
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer
- Achieved complete remission with normal CA 125 after first-line platinum-containing chemotherapy
- Prior participation in the following clinical trials is allowed:
- MRC-ICON2 (carboplatin vs cyclophosphamide, doxorubicin, and cisplatin for advanced disease)
- MRC-ICON3 (paclitaxel with carboplatin in first-line therapy for advanced disease)
- MRC-ICON5 (carboplatin and paclitaxel vs triplet and sequential doublet combinations of chemotherapy)
- No prior participation in MRC-ICON1 (adjuvant chemotherapy for early-stage ovarian cancer)
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No prior or concurrent malignancy within the past 5 years that is likely to preclude study treatment or comparisons except for nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Trial locations and contacts
21 sites in 10 countries.
21 sites in 10 countries
Netherlands7 sites
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, 1105 AZ
Leiden University Medical Center
Leiden, 2300 RC
Nijmegen Cancer Center at Radboud University Medical Center
Nijmegen, NL-6500 HB
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, 3008 AE
Leyenburg Ziekenhuis
The Hague, 2545 CH
University Medical Center Utrecht
Utrecht, 3508 GA
Isala Klinieken - locatie Sophia
Zwolle, 8000 GK
Belgium3 sites
Institut Jules Bordet
Brussels, 1000
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, 1090
Cazk Groeninghe - Campus Maria's Voorzienigheid
Kortrijk, B-8500
Spain3 sites
Institut d'Oncologia Corachan
Barcelona, 08017
Hospital Universitario San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
United Kingdom1 site
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN
About this study
Official title: A Randomised Trial in Relapsed Ovarian Cancer: Early Treatment Based on CA 125 Levels Alone Vs. Delayed Treatment Based On Conventional Clinical Indicators
RATIONALE: It is not yet known if treatment for recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer is more effective if it is begun when blood levels of CA 125 become elevated rather than waiting for other indicators of disease recurrence.
PURPOSE: This randomized phase III trial is studying early chemotherapy based on blood levels of CA 125 alone to see how well it works compared to chemotherapy based on conventional clinical indicators in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.
Read the detailed description
OBJECTIVES:
- Compare the benefit of early chemotherapy based on CA 125 level only vs chemotherapy based on conventional clinical indicators in patients with relapsed ovarian epithelial, fallopian tube, or primary peritoneal cancer.
- Compare the overall survival of patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients whose CA 125 levels rise to more than two times the upper limit of normal are randomized to one of two treatment arms.
- Arm I: The clinician is informed of the initial rise in CA 125 level. A confirmatory test is performed immediately. Within 4 weeks of the initial CA 125 elevation, patients with a second confirmed elevation receive treatment for recurrent disease according to standard local practice. Patients with a normal CA 125 on the confirmatory test receive no treatment until clinically indicated.
- Arm II: The clinician is blinded to the CA 125 results. Patients undergo normal monitoring. When clinically indicated, patients commence treatment according to standard local practice.
Quality of life is assessed at baseline, at each follow-up visit, and, if treatment is instituted, before each chemotherapy course.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 1,400 patients will be accrued for this study.
- Being tested
- chemotherapy
- Keywords
- recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Benefit of early chemotherapy
Overall survival
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 1996
- Study completionOct 2010
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 Fallopian Tube 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
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Investigators
- Gordon J.S. Rustin, MD, Mount Vernon Cancer Centre at Mount Vernon HospitalM. E.L. van der Burg, MD, PhD, University Medical Center Rotterdam at Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002895
- Sponsor's protocol ID
- CDR0000065218
- Other IDs
- MRC-OV05, EORTC-55955, ISRCTN87786644
- Status last verified
- Sep 2005
- First submitted
- 1 Nov 1999
- Last updated
- 4 Dec 2013
- Results posted
- No
Publications
Markman M, Petersen J, Belland A, Burg K. CA-125 monitoring in ovarian cancer: patient survey responses to the results of the MRC/EORTC CA-125 Surveillance Trial. Oncology. 2010;78(1):1-2. doi: 10.1159/000292352. Epub 2010 Mar 6. No abstract available.
PubMed 20215782Rustin GJ, van der Burg ME, Griffin CL, Guthrie D, Lamont A, Jayson GC, Kristensen G, Mediola C, Coens C, Qian W, Parmar MK, Swart AM; MRC OV05; EORTC 55955 investigators. Early versus delayed treatment of relapsed ovarian cancer (MRC OV05/EORTC 55955): a randomised trial. Lancet. 2010 Oct 2;376(9747):1155-63. doi: 10.1016/S0140-6736(10)61268-8.
PubMed 20888993Rustin GJ, van der Burg ME: A randomized trial in ovarian cancer (OC) of early treatment of relapse based on CA125 level alone versus delayed treatment based on conventional clinical indicators (MRC OV05/EORTC 55955 trials). [Abstract] J Clin Oncol 27 (Suppl 18): A-1, 2009.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial in Relapsed Ovarian Cancer: Early Treatment Based on CA 125 Levels Alone Vs. Delayed Treatment Based On Conventional Clinical Indicators
- ClinicalTrials.gov ID
- NCT00002895
- Acronym / sponsor ID
- CDR0000065218
- Keywords
- recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Medical Research CouncilOther government
- Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC
- Study start
- Jun 1996
- Study completion
- Oct 2010 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: It is not yet known if treatment for recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer is more effective if it is begun when blood levels of CA 125 become elevated rather than waiting for other indicators of disease recurrence.
PURPOSE: This randomized phase III trial is studying early chemotherapy based on blood levels of CA 125 alone to see how well it works compared to chemotherapy based on conventional clinical indicators in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.
Detailed description
OBJECTIVES:
- Compare the benefit of early chemotherapy based on CA 125 level only vs chemotherapy based on conventional clinical indicators in patients with relapsed ovarian epithelial, fallopian tube, or primary peritoneal cancer.
- Compare the overall survival of patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients whose CA 125 levels rise to more than two times the upper limit of normal are randomized to one of two treatment arms.
- Arm I: The clinician is informed of the initial rise in CA 125 level. A confirmatory test is performed immediately. Within 4 weeks of the initial CA 125 elevation, patients with a second confirmed elevation receive treatment for recurrent disease according to standard local practice. Patients with a normal CA 125 on the confirmatory test receive no treatment until clinically indicated.
- Arm II: The clinician is blinded to the CA 125 results. Patients undergo normal monitoring. When clinically indicated, patients commence treatment according to standard local practice.
Quality of life is assessed at baseline, at each follow-up visit, and, if treatment is instituted, before each chemotherapy course.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 1,400 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| chemotherapy | Drug | – |
Primary outcome
Benefit of early chemotherapy
Overall survival
Quality of life
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 4 Dec 2013.
- Background: PubMed 20215782Markman M, Petersen J, Belland A, Burg K. CA-125 monitoring in ovarian cancer: patient survey responses to the results of the MRC/EORTC CA-125 Surveillance Trial. Oncology. 2010;78(1):1-2. doi: 10.1159/000292352. Epub 2010 Mar 6. No abstract available.
- Results publication: PubMed 20888993Rustin GJ, van der Burg ME, Griffin CL, Guthrie D, Lamont A, Jayson GC, Kristensen G, Mediola C, Coens C, Qian W, Parmar MK, Swart AM; MRC OV05; EORTC 55955 investigators. Early versus delayed treatment of relapsed ovarian cancer (MRC OV05/EORTC 55955): a randomised trial. Lancet. 2010 Oct 2;376(9747):1155-63. doi: 10.1016/S0140-6736(10)61268-8.
- Results publicationRustin GJ, van der Burg ME: A randomized trial in ovarian cancer (OC) of early treatment of relapse based on CA125 level alone versus delayed treatment based on conventional clinical indicators (MRC OV05/EORTC 55955 trials). [Abstract] J Clin Oncol 27 (Suppl 18): A-1, 2009.
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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.
Gordon J.S. Rustin, MD
Mount Vernon Cancer Centre at Mount Vernon Hospital
M. E.L. van der Burg, MD, PhD
University Medical Center Rotterdam at Erasmus Medical Center
21 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing chemotherapy in people with Fallopian Tube Cancer and Ovarian Cancer, run by Medical Research Council at 21 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Netherlands, Belgium, Spain, Ireland, Austria and 5 more countries. 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?
Benefit of early chemotherapy. The study lists 3 primary outcomes in all. 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 NCT00002895, 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 4 Dec 2013.