Breast CancerPhase 3ENRICHNCT00083304
Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer
A Phase 3 study testing Efaproxiral, Whole Brain Radiation Therapy (WBRT) and Supplemental Oxygen in people with Breast Cancer and Metastases, run by Spectrum Pharmaceuticals, Inc at 94 sites in 15 countries.
Trial summary
RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Metastases
- What is being tested?
- Efaproxiral, Whole Brain Radiation Therapy (WBRT) and Supplemental Oxygen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 94 sitesin 15 countries
- Study dates
- Feb 2004to Jun 2007
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women with brain metastases from breast cancer
- Minimum KPS of 70
Who cannot join
- Previous treatment for brain metastases, including brain surgery and any form of radiation to the brain
Trial locations and contacts
94 sites in 15 countries.
94 sites in 15 countries
United States39 sites
Dent Neurologic Institute
Amherst, New York, 14226
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
Maryland Hematology Oncology
Baltimore, Maryland, 21236
Franklin Square Hospital Center
Baltimore, Maryland, 21237
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Boca Raton Community Hospital
Boca Raton, Florida, 33486
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
SUNY Downstate Medical Center
Brooklyn, New York, 11203
University of North Carolina Breast Center
Chapel Hill, North Carolina, 27599
Northwestern University
Chicago, Illinois, 60611
University of Cincinnati Division of Hematology-Oncology
Cincinnati, Ohio, 45267
Cleveland Clinic Hospital
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Texas Oncology
Dallas, Texas, 75230
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Parkview Research Center
Fort Wayne, Indiana, 46805
Texas Oncology
Fort Worth, Texas, 76104
Indiana University School of Medicine
Indianapolis, Indiana, 46204
The University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of California at Los Angeles
Los Angeles, California, 90095
University of Wisconsin
Madison, Wisconsin, 53792
University of Miami Medical
Miami, Florida, 33136
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Yale University School of Medicine
New Haven, Connecticut, 06520
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Virginia G. Piper Cancer Center, Arizona Oncology Services
Phoenix, Arizona, 85013
Radiological Associates of Sacramento
Sacramento, California, 95816
UCSF - Comprehensive Cancer Center
San Francisco, California, 94115
Virginia Mason Cancer Center
Seattle, Washington, 98101
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101
Washington University School of Medicine
St Louis, Missouri, 63110
University of South Florida - H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
Eastchester Center for Cancer Care
The Bronx, New York, 10469
Arizona Cancer Center, University of Arizona
Tucson, Arizona, 85724-5081
Wenatchee Valley Clinic
Wenatchee, Washington, 98801
Canada10 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Center
Edmonton, Alberta, T6G 1Z2
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
CHUM - Campus Notre Dame
Montreal, Quebec, H2L 4M1
McGill University
Montreal, Quebec, H2W 1S6
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Hotel-Dieu de Quebec du CHUQ
Québec, Quebec, G1R 5C3
Centre Hospitalier Universitarie de Service de Radio-Oncologie
Sherbrooke, Quebec, J1H 5N4
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
France10 sites
Centre Georges François Leclerc
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
Centre Léon Bérard
Lyon, 69373
Hopital de Montbeliard
Montbéliard, 25209
Centre Antioned Lacasagne
Nice, 06 189
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
CHU Poitiers
Poitiers, 86021
Clinique Armoricaine de
Saint-Brieuc, 22015
Centre Rene Huguenin
Saint-Cloud, 92210
Institut Gustave Roussy
Villejuif, 94 805
Brazil6 sites
Fundação Pio XII - Hospital do Câncer de Barretos
Barretos, São Paulo, 14780-400
Hospital Erasto Gaertner
Curitiba, 81520-060
Velindre Hospital
Porto Alegre, 90610-000
Hospital Santa Rita da Irmandade da Santa Casa
Porto Alegre, CEP 90020-090
Instituto Brasileiro de Controle do Cancer
São Paulo, CEP 03102-002
Hospital Sao Lucas PUC
Teófilo, Fortaleza Ceara, 60430-230
Argentina5 sites
Instituto Medico Especializado Alexander Fleming
Buenos Aires, Cuidad de Buenos Aires, C1426ANZ
Instituto de Oncologia A. Roffo
Buenos Aires, CP 1417
Hospital Espanol
Buenos Aires, CP C1209
Instituto Privado de Radioterapia y Oncologia
Córdoba, CP 5000
Centro de Terapia Radiante Cumbres (CAICI)
Rosario, 2000
Spain5 sites
Instituto Catalan de Oncologia (ICO)
Barcelona, 08907
Ciutat Sanitari de Vall d'Hebron
Barcelona, 8035
Hospital Ramon Y Cajal
Madrid, 28034
Clinica Universitaria de Navarra
Pamplona, 31008
Instituto Valenciano de Oncologia
Valencia, 46009
Croatia3 sites
Clinical Hospital Osijek
Osijek, 4
CHU Zagreb University School of Medicine
Zagreb, 10000
University Hospital for Tumors
Zagreb, 197
Peru3 sites
Hospital Edgardo Rebagliati Martins (ESSALUD)
Lima, 11
Radiooncologia, Radiation Oncology Center
Lima, 27
Instituto de Enfermedades Neoplasicas (INEN)
Lima, 34
United Kingdom3 sites
Royal Sussex County Hospital
Brighton, BN2 5BE
Beatson Oncolgy Center
Glasgow, G11 6NT
Velindre Hospital
Whitchurch, Cardiff, CF14 2TL
Austria2 sites
LKH-Universitatsklinikum Graz
Graz, A-8036
Medical University Innsbruck
Innsbruck, 6020
Hungary2 sites
University of Debrecen
Debrecen, Hajdú-Bihar, 4032
University of Szeged
Szeged, H-6720
Italy2 sites
Azienda Ospedaliera Maggiore della Carita
Novara, 28100
Ospedale S Chiara, University of Pisa
Pisa, 56100
Lithuania2 sites
Kaunas Medical University Hospital
Kaunas, 50009
Institute of Oncology, Vilnius University
Vilnius, LT-086660
About this study
Official title: A Phase 3 Randomized, Open-label Comparative Study of Standard Whole Brain Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Women With Brain Metastases From Breast Cancer
RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy.
RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better.
This study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place.
Read the detailed description
The screening process will include documentation of the cancer, which which will require a brain scan and may include a liver scan. Other screening measurements will include a Karnofsky Performance Status (KPS) assessment, measurement of the amount of oxygen in the blood, using a non-invasive device most often placed on the finger, lung function tests that will require blowing into a machine, and an electrocardiogram (ECG). About 2 teaspoons, or 10 mL, of blood will be taken for specific laboratory tests, and a pregnancy test will be done on the blood of women of childbearing potential.
All study patients will receive supplemental oxygen and whole brain radiation therapy (WBRT) (30 Gy, 3 Gy fractions) every weekday for 2 weeks. Half of the patients will be randomized (assigned) to receive RSR13 prior to WBRT, and will need to have a central catheter placed for treatment unless one is already in place. Patients who receive RSR13 will also need to continue to receive oxygen in the clinic until the amount of oxygen in their blood is near normal. This level has returned to near normal in most patients within 1 to 2 hours.
During treatment and follow-up visits, physical and neurological exam, KPS assessment, weight, height, and vital sign measurements, and about 2 teaspoons of blood may be required. Patients will need to return for follow-up visits 1 month after completion of treatment, 2 months later, and every 3 months thereafter until their doctor tells them otherwise.
- Conditions
- Breast Cancer, Metastases
- Being tested
- Efaproxiral, Whole Brain Radiation Therapy (WBRT), Supplemental Oxygen
- Keywords
- Breast, Brain, RSR13, efaproxiral, Whole Brain Radiation Therapy, Brain metastases, Metastatic breast cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfaproxiralDrug
Also called RSR13
75 mg/kg, administered over 30 minutes via a central venous access device (CVAD).
Administered 30 minutes prior to the start of whole brain radiation therapy (WBRT) on each WBRT treatment day for 10 days.
Whole Brain Radiation Therapy (WBRT)Radiation
3.0 Gy per day for 10 days (30.0 Gy total) of WBRT.
Supplemental OxygenOther
4 L/minute by nasal cannula.
Administered at least 35 minutes prior to WBRT, during WBRT and until 15 minutes after completion of WBRT on all WBRT treatment days.
| Study group | Role | What they receive |
|---|---|---|
| Efaproxiral + WBRT + Supplemental Oxygen | Experimental | Not described Receives: Drug: Efaproxiral; Radiation: Whole Brain Radiation Therapy (WBRT); Other: Supplemental Oxygen |
| WBRT + Supplemental Oxygen | Active comparator | Not described Receives: Radiation: Whole Brain Radiation Therapy (WBRT); Other: Supplemental Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: Measured from randomization until death due to any cause.
Secondary outcomes (2)
Response Rate in the Brain at 3 Months
Measured: Assessed at screening, 3 months after end of study treatment and at least 4 weeks after the 3-month scan.
Karnofsky Performance Status & Neurological Signs & Symptoms
Measured: Assessed at baseline, 1 month follow-up (FU) visit, 3 month FU visit, and 6 month FU visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2004 (estimated)
- Study startFeb 2004
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Single group
- Masking
- None (open label)
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John Suh, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00083304
- Sponsor's protocol ID
- RT-016
- Acronym
- ENRICH
- Status last verified
- May 2013
- First submitted
- 18 May 2004
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Open-label Comparative Study of Standard Whole Brain Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Women With Brain Metastases From Breast Cancer
- ClinicalTrials.gov ID
- NCT00083304
- Acronym / sponsor ID
- ENRICH / RT-016
- Conditions
- Breast Cancer, Metastases
- Keywords
- Breast, Brain, RSR13, efaproxiral, Whole Brain Radiation Therapy, Brain metastases, Metastatic breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 19 May 2004 (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.
RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy.
RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better.
This study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place.
Detailed description
The screening process will include documentation of the cancer, which which will require a brain scan and may include a liver scan. Other screening measurements will include a Karnofsky Performance Status (KPS) assessment, measurement of the amount of oxygen in the blood, using a non-invasive device most often placed on the finger, lung function tests that will require blowing into a machine, and an electrocardiogram (ECG). About 2 teaspoons, or 10 mL, of blood will be taken for specific laboratory tests, and a pregnancy test will be done on the blood of women of childbearing potential.
All study patients will receive supplemental oxygen and whole brain radiation therapy (WBRT) (30 Gy, 3 Gy fractions) every weekday for 2 weeks. Half of the patients will be randomized (assigned) to receive RSR13 prior to WBRT, and will need to have a central catheter placed for treatment unless one is already in place. Patients who receive RSR13 will also need to continue to receive oxygen in the clinic until the amount of oxygen in their blood is near normal. This level has returned to near normal in most patients within 1 to 2 hours.
During treatment and follow-up visits, physical and neurological exam, KPS assessment, weight, height, and vital sign measurements, and about 2 teaspoons of blood may be required. Patients will need to return for follow-up visits 1 month after completion of treatment, 2 months later, and every 3 months thereafter until their doctor tells them otherwise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efaproxiral + WBRT + Supplemental Oxygen | Experimental | Drug: Efaproxiral, Radiation: Whole Brain Radiation Therapy (WBRT), Other: Supplemental Oxygen |
| WBRT + Supplemental Oxygen | Active comparator | Radiation: Whole Brain Radiation Therapy (WBRT), Other: Supplemental Oxygen |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult women with brain metastases from breast cancer
- Minimum KPS of 70
Key exclusion criteria (1 listed)
- Previous treatment for brain metastases, including brain surgery and any form of radiation to the brain
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 |
|---|---|---|
| EfaproxiralAlso: RSR1375 mg/kg, administered over 30 minutes via a central venous access device (CVAD). Administered 30 minutes prior to the start of whole brain radiation therapy (WBRT) on each WBRT treatment day for 10 days. | Drug | Efaproxiral + WBRT + Supplemental Oxygen |
| Whole Brain Radiation Therapy (WBRT)3.0 Gy per day for 10 days (30.0 Gy total) of WBRT. | Radiation | Efaproxiral + WBRT + Supplemental Oxygen, WBRT + Supplemental Oxygen |
| Supplemental Oxygen4 L/minute by nasal cannula. Administered at least 35 minutes prior to WBRT, during WBRT and until 15 minutes after completion of WBRT on all WBRT treatment days. | Other | Efaproxiral + WBRT + Supplemental Oxygen, WBRT + Supplemental Oxygen |
Primary outcome
Overall Survival
Time frame: Measured from randomization until death due to any cause.
2 secondary outcomes
Response Rate in the Brain at 3 Months
Time frame: Assessed at screening, 3 months after end of study treatment and at least 4 weeks after the 3-month scan.
Karnofsky Performance Status & Neurological Signs & Symptoms
Time frame: Assessed at baseline, 1 month follow-up (FU) visit, 3 month FU visit, and 6 month FU visit.
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 10 May 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.
John Suh, MD study chair
The Cleveland Clinic
94 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Efaproxiral, Whole Brain Radiation Therapy (WBRT) and Supplemental Oxygen in people with Breast Cancer and Metastases, run by Spectrum Pharmaceuticals, Inc at 94 sites in 15 countries.
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 2 inclusion and 1 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 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in United States, Canada, France, Brazil, Argentina and 10 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?
Overall Survival (time frame: Measured from randomization until death due to any cause.). 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 10 May 2013.