Brain and Central Nervous System TumorsPhase 3NCT00445497
Early Hospital Discharge or Standard Inpatient Care in Cancer Patients Receiving Antibiotics for Febrile Neutropenia
A Phase 3 study testing amoxicillin-clavulanate potassium, ciprofloxacin and psychosocial assessment and care in people with Brain and Central Nervous System Tumors and Lymphoma, run by Clatterbridge Centre for Oncology at 10 sites in United Kingdom.
Trial summary
RATIONALE: Finishing an antibiotic regimen at home may be as effective as receiving it in the hospital. It is not yet known whether early hospital discharge is as effective as standard inpatient care in cancer patients receiving antibiotics for febrile neutropenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors, Lymphoma, Neutropenia
- What is being tested?
- amoxicillin-clavulanate potassium, ciprofloxacin and psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- Jul 2007to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of solid tumor or lymphoma AND meets the following criteria:
- Low-risk patient, defined as Multinational Association for Supportive Care in Cancer prognostic index score ≥ 21
- Presents with neutropenic fever defined as follows:
- Absolute neutrophil count ≤ 500/mm³ OR < 1,000/mm³ but anticipated to fall to ≤ 500/mm³ within 24 hours of study entry
- Temperature ≥ 38.5°C on a single measurement or ≥ 38.0°C on > 1 occasion (one of which could be measured by the patient prior to admission) ≥ 1 hour apart
- Undergoing concurrent cytotoxic chemotherapy for treatment of solid tumors or lymphoma
- No leukemia
PATIENT CHARACTERISTICS:
- Compliant and appropriate for early discharge
- Able to read a thermometer (patient or caregiver)
- Able to tolerate oral medication
- Must have a responsible adult caregiver if eligible for early discharge
- No known allergy to oral antibiotics or penicillin
- No requirement for IV fluid support
- No central venous catheter-associated infection or evidence of infection not amenable to treatment by study antibiotics
- No neutropenic fever at high risk of complications
- No associated comorbidity that requires hospitalization and management
- No known HIV positivity
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior participation in this study for neutropenic episode
- No prior bone marrow transplantation or peripheral blood stem cell transplantation
- No prior treatment for leukemia
- More than 72 hours since prior antibiotics, including prophylactic antibiotics
- Prophylactic septrin (for pneumocystis), acyclovir, or antifungals are allowed
- No concurrent granulocyte colony-stimulating factor therapy
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites, 10 recruiting
- Recruiting
Ysbyty Gwynedd
Bangor, Wales, LL57 2PW
Contact Person, 44-0124-838-4384
- Recruiting
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, GL53 7AN
Contact Person, 44-0124-2222-2222
- Recruiting
Western Infirmary
Glasgow, Scotland, G11 6NT
Contact Person, 44-0114-226-5000
- Recruiting
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, HU8 9HE
Contact Person, 44-0148-2701151
- Recruiting
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Contact Person, 44-011-6254-1414
- Recruiting
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY
Ernest Marshall, MD, 44-151-334-1155
- Recruiting
Northampton General Hospital
Northampton, England, NN1 5BD
Contact Person, 44-016-0463-4700
- Recruiting
Peterborough Hospitals Trust
Peterborough, England, PE3 6DA
Contact Person, 44-0173-387-4000
- Recruiting
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ
Contact Person, 44-114-226-5000
- Recruiting
Airedale General Hospital
West Yorkshire, England, BD20 6TD
Contact Person, 44-015-356-2511
About this study
Official title: A Prospective Randomised Phase III Trial of Early Hospital Discharge Versus Standard Inpatient Management of Cancer Patients With Low-Risk Febrile Neutropenia Receiving Oral Antibiotics. Oral Antibiotics for Neutropenic Sepsis Giving Early Hospital Discharge [ORANGE]
RATIONALE: Finishing an antibiotic regimen at home may be as effective as receiving it in the hospital. It is not yet known whether early hospital discharge is as effective as standard inpatient care in cancer patients receiving antibiotics for febrile neutropenia.
PURPOSE: This randomized phase III trial is studying early hospital discharge and comparing it with standard inpatient care in cancer patients receiving antibiotics for febrile neutropenia.
Read the detailed description
OBJECTIVES:
- Identify cancer patients who are low-risk inpatients and meet criteria for early discharge (i.e., symptomatic improvement and temperature ≤ 37.8°C) after receiving oral antibiotics for febrile neutropenia.
OUTLINE: This is a randomized, prospective, multicenter study. Patients are stratified by disease type (lymphoma vs solid tumor), duration of registration (< 48 hours vs > 48 hours), and participating center.
Patients receive oral amoxicillin-clavulanate potassium 3 times daily and oral ciprofloxacin twice daily on admission to the hospital. Treatment continues for 7 days in the absence of clinical deterioration or unacceptable toxicity. Patients are assessed as inpatients after ≥ 24 and up to 72 hours after the first antibiotic dose. Patients showing clear response (i.e., symptomatic improvement irrespective of neutrophil recovery, temperature ≤ 37.8 C for 24 hours) and who continue to meet study eligibility criteria are randomized to 1 of 2 arms.
- Arm I (early discharge): Patients are discharged home and instructed to remain in daily contact with hospital staff to report temperature and symptoms until completion of oral antibiotic regimen.
- Arm II (standard management): Patients continue their antibiotic course in hospital and are discharged according to local guidelines and the following additional criteria: subjective improvement, afebrile (≤ 37°C for 24 hours), and absolute neutrophil count ≥ 500/mm³ and rising.
Patients in both arms complete a daily diary documenting daily temperature readings, symptoms, and toxicities. Patients also complete a Health Questionnaire and a Cancer Worries Inventory Booklet at baseline, in the hospital immediately after randomization, and at completion of oral antibiotics or resolution of neutropenic febrile episode.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors, Lymphoma, Neutropenia, Psychosocial Effects of Cancer and Its Treatment, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- amoxicillin-clavulanate potassium, ciprofloxacin, psychosocial assessment and care, quality-of-life assessment
- Keywords
- psychosocial effects of cancer and its treatment, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, intraocular lymphoma, nodal marginal zone B-cell lymphoma, primary central nervous system non-Hodgkin lymphoma, primary central nervous system Hodgkin lymphoma, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma
- Medical subject headings
- Central Nervous System Neoplasms, Lymphoma, Neutropenia, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Intraocular Lymphoma, Lymphoma, B-Cell, Marginal Zone, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillin-clavulanate potassiumDrug
ciprofloxacinDrug
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of days of hospitalization (including unplanned readmission) (randomized patients)
Incidence of serious adverse events (randomized and registered patients)
Secondary outcomes (5)
Incidence of treatment failure as defined by the necessity for change in antibiotic therapy (randomized and registered patients)
Incidence of unplanned readmissions (randomized patients)
Patient acceptability of randomized discharge policy as measured by Health Questionnaire, Cancer Worries Inventory Booklet, and Patient Daily Diary (randomized patients)
Toxicity attributed to oral antibiotic therapy as measured by NCI CTCAE v3.0 (randomized and registered patients)
Health service costs (randomized patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies 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
- Supportive care
- Allocation
- Randomised
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clatterbridge Centre for Oncology
- Sponsor type
- University, hospital or other
- Investigators
- Ernest Marshall, MD, Study chair, Clatterbridge Centre for Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445497
- Sponsor's protocol ID
- CRUK-MX3006
- Other IDs
- CDR0000533828, CRUK-ORANGE, ISRCTN18467252, EU-20707
- Status last verified
- May 2007
- First submitted
- 7 Mar 2007
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Phase III Trial of Early Hospital Discharge Versus Standard Inpatient Management of Cancer Patients With Low-Risk Febrile Neutropenia Receiving Oral Antibiotics. Oral Antibiotics for Neutropenic Sepsis Giving Early Hospital Discharge [ORANGE]
- ClinicalTrials.gov ID
- NCT00445497
- Acronym / sponsor ID
- CRUK-MX3006
- Conditions
- Brain and Central Nervous System Tumors, Lymphoma, Neutropenia, Psychosocial Effects of Cancer and Its Treatment, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- psychosocial effects of cancer and its treatment, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, intraocular lymphoma, nodal marginal zone B-cell lymphoma, primary central nervous system non-Hodgkin lymphoma, primary central nervous system Hodgkin lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Clatterbridge Centre for OncologyUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2010 (estimated)
- First posted
- 9 Mar 2007 (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: Finishing an antibiotic regimen at home may be as effective as receiving it in the hospital. It is not yet known whether early hospital discharge is as effective as standard inpatient care in cancer patients receiving antibiotics for febrile neutropenia.
PURPOSE: This randomized phase III trial is studying early hospital discharge and comparing it with standard inpatient care in cancer patients receiving antibiotics for febrile neutropenia.
Detailed description
OBJECTIVES:
- Identify cancer patients who are low-risk inpatients and meet criteria for early discharge (i.e., symptomatic improvement and temperature ≤ 37.8°C) after receiving oral antibiotics for febrile neutropenia.
OUTLINE: This is a randomized, prospective, multicenter study. Patients are stratified by disease type (lymphoma vs solid tumor), duration of registration (< 48 hours vs > 48 hours), and participating center.
Patients receive oral amoxicillin-clavulanate potassium 3 times daily and oral ciprofloxacin twice daily on admission to the hospital. Treatment continues for 7 days in the absence of clinical deterioration or unacceptable toxicity. Patients are assessed as inpatients after ≥ 24 and up to 72 hours after the first antibiotic dose. Patients showing clear response (i.e., symptomatic improvement irrespective of neutrophil recovery, temperature ≤ 37.8 C for 24 hours) and who continue to meet study eligibility criteria are randomized to 1 of 2 arms.
- Arm I (early discharge): Patients are discharged home and instructed to remain in daily contact with hospital staff to report temperature and symptoms until completion of oral antibiotic regimen.
- Arm II (standard management): Patients continue their antibiotic course in hospital and are discharged according to local guidelines and the following additional criteria: subjective improvement, afebrile (≤ 37°C for 24 hours), and absolute neutrophil count ≥ 500/mm³ and rising.
Patients in both arms complete a daily diary documenting daily temperature readings, symptoms, and toxicities. Patients also complete a Health Questionnaire and a Cancer Worries Inventory Booklet at baseline, in the hospital immediately after randomization, and at completion of oral antibiotics or resolution of neutropenic febrile episode.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| amoxicillin-clavulanate potassium | Drug | – |
| ciprofloxacin | Drug | – |
| psychosocial assessment and care | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Total number of days of hospitalization (including unplanned readmission) (randomized patients)
Incidence of serious adverse events (randomized and registered patients)
5 secondary outcomes
Incidence of treatment failure as defined by the necessity for change in antibiotic therapy (randomized and registered patients)
Incidence of unplanned readmissions (randomized patients)
Patient acceptability of randomized discharge policy as measured by Health Questionnaire, Cancer Worries Inventory Booklet, and Patient Daily Diary (randomized patients)
Toxicity attributed to oral antibiotic therapy as measured by NCI CTCAE v3.0 (randomized and registered patients)
Health service costs (randomized patients)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 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.
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, United Kingdom
Ernest Marshall, MD study chair
Clatterbridge Centre for Oncology
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing amoxicillin-clavulanate potassium, ciprofloxacin and psychosocial assessment and care in people with Brain and Central Nervous System Tumors and Lymphoma, run by Clatterbridge Centre for Oncology at 10 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of days of hospitalization (including unplanned readmission) (randomized patients). The study lists 2 primary outcomes in all. 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 12 Aug 2013.