Colorectal CancerPhase 3NCT00482222
Combination Chemotherapy With or Without Cetuximab Before and After Surgery in Treating Patients With Resectable Liver Metastases Caused By Colorectal Cancer
A Phase 3 study testing cetuximab, capecitabine and fluorouracil in people with Colorectal Cancer and Metastatic Cancer, run by University of Southampton at 22 sites in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Metastatic Cancer
- What is being tested?
- cetuximab, capecitabine and fluorouracil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 22 sitesUnited Kingdom
- Study dates
- Feb 2007to Dec 2014
- 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:
- Histologically* or radiologically confirmed primary adenocarcinoma of the colon or rectum
- Advanced and/or metastatic disease NOTE: *Liver metastases should not be biopsied
- Must have potentially resectable liver metastases present, as defined by any of the following:
- Metachronous metastases AND complete resection of the primary tumor without gross or microscopic evidence of residual disease (R0)
- Synchronous metastases AND R0 resection of the primary tumor > 1 month before study entry
- Synchronous metastases with sufficient evidence (e.g., by CT scan or diagnostic laparoscopy) that both the primary tumor and the liver metastases can be completely resected during the same procedure and resection of primary tumor can be delayed for 3-4 months
- Suboptimally resectable disease (i.e., potentially resectable disease with compromise of the resection margins)
- No detectable extrahepatic tumor that cannot be completely resected
- Unidimensionally measurable disease
- No brain metastases
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- WBC ≥ 4,000/mm³
- ANC ≥ 1,500/mm³
- Platelet count > 150,000/mm³
- Bilirubin ≤ 1.25 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 5 times ULN
- AST or ALT ≤ 3 times ULN
- Creatinine clearance > 50 mL/min OR glomerular filtration rate > 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
- No psychiatric or neurological condition that would preclude study compliance
- No partial or complete bowel obstruction
- No preexisting neuropathy > grade 1
- No other prior or concurrent malignant disease that, in the opinion of the investigator, would preclude study treatment
- No concurrent severe uncontrolled medical illness (including poorly-controlled angina or myocardial infarction within the past 3 months) that would preclude study treatment
- No known hypersensitivity reaction to any of the components of the study drugs
PRIOR CONCURRENT THERAPY:
- No prior systemic chemotherapy for metastatic disease
- More than 6 months since prior adjuvant chemotherapy comprising fluorouracil, leucovorin calcium, capecitabine, or irinotecan hydrochloride
- More than 1 month since prior rectal chemoradiotherapy comprising fluorouracil and leucovorin calcium
- No concurrent contraindicated medication
Trial locations and contacts
22 sites in 1 country.
Louisa Little contact
22 sites in 1 country
United Kingdom22 sites, 22 recruiting
- Recruiting
Basildon University Hospital
Basildon, England, SS16 5NL
Pauline Leonard, MD, 44-1702-435-555
- Recruiting
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, RG24 9NA
Charlotte Rees, MD, 44-125-631-4793
- Recruiting
Royal Bournemouth Hospital
Bournemouth, England, BH7 7DW
Tamas Hickish, MD, 44-1202-303-626, tamas.hickish@rbch.nhs.uk
- Recruiting
Addenbrooke's Hospital
Cambridge, England, CB2 0QQ
Pippa Corrie, PhD, FRCP, 44-1223-274-401, pippa.corrie@addenbrookes.nhs.uk
- Recruiting
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Timothy Maughan, MD, 44-2920-316-904
- Recruiting
University Hospital of Wales
Cardiff, Wales, CF14 4XW
Timothy Maughan, MD, 44-2920-316-904
- Recruiting
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, GU2 7XX
Sharadah Essapen, MD, 44-1483-571-122
- Recruiting
Aintree University Hospital
Liverpool, England, L9 7AL
Graeme J. Poston, MD, 44-151-525-5980, graeme.poston@aintree.nhs.uk
- Recruiting
Royal Liverpool University Hospital
Liverpool, England, L9 7AL
Paula Ghaneh, MD
- Recruiting
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Sarah Slater, MD, 44-20-7601-8391
- Recruiting
UCL Cancer Institute
London, England, NW3 2PF
Astrid Mayer, MD, 44-207-794-0500, a.mayer@ucl.ac.uk
- Recruiting
Royal Marsden - London
London, England, SW3 6JJ
David Cunningham, MD, 44-20-8661-3156
- Recruiting
Charing Cross Hospital
London, England, W6 8RF
Charles P. Lowdell, MD, BSc, MBBS, FRCP, FRCR, 44-208-383-0576, charles.lowdell@imperial.nhs.uk
- Recruiting
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY
David Smith, MD, 44-151-334-1155, david.smith@ccotrust.nhs.uk
- Recruiting
St. Mary's Hospital
Newport, England, PO30 5TG
Christopher Baughan, MD, 44-1983-524-081
- Recruiting
Cancer Research Centre at Weston Park Hospital
Nottingham, England, NG5 1PB
J. Hornbuckle, MD, 44-115-969-1169 ext. 47599
- Recruiting
Dorset Cancer Centre
Poole Dorset, England, BH15 2JB
Tamas Hickish, MD, 44-1202-442-532
- Recruiting
Salisbury District Hospital
Salisbury, England, SP2 8BJ
Tim J. Iveson, MD, 44-1722-336-262 ext. 4688
- Recruiting
Southampton General Hospital
Southampton, England, SO16 6YD
John N. Primrose, MD, 44-23-8079-6144, j.n.primrose@soton.ac.uk
- Recruiting
Royal Marsden - Surrey
Sutton, England, SM2 5PT
David Cunningham, MD, 44-20-8661-3279, david.cunningham@rmh.nhs.uk
- Recruiting
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY
Pauline Leonard, MD, 44-1702-435-555
- Recruiting
Worthing Hospital
Worthing, England, BN11 2DH
Andrew Webb, MD, 44-1903-205-111
About this study
Official title: A Prospective Randomised Open Label Trial of Oxaliplatin/Fluoropyrimidine Versus Oxaliplatin/Fluoropyrimidine Plus Cetuximab Pre and Post Operatively in Patients With Resectable Colorectal Liver Metastasis Requiring Chemotherapy
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without cetuximab in treating liver metastases caused by colorectal cancer.
PURPOSE: This randomized phase III trial is studying combination chemotherapy to compare how well it works when given with or without cetuximab before and after surgery in treating patients with resectable liver metastases caused by colorectal cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare progression-free survival of patients with resectable colorectal liver metastases treated with neoadjuvant and adjuvant combination chemotherapy with vs without cetuximab.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the cost effectiveness of these regimens in these patients.
OUTLINE: This is a prospective, randomized, multicenter, open-label study. Patients are stratified according to participating center and assigned chemotherapy regimen. Patients are randomized to 1 of 2 treatment arms.
- Neoadjuvant therapy:
- Arm I: Patients receive 1 of the following chemotherapy regimens:
- OxMdG: Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- CAPOX: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive 1 of the following regimens:
- OxMdG + cetuximab: Patients receive cetuximab IV over 1-2 hours on day 1 and OxMdG chemotherapy as in arm I. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- CAPOX + cetuximab: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and CAPOX chemotherapy as in arm I. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Surgery: Beginning 2-6 weeks after completion of chemotherapy, patients in both arms undergo liver resection.
- Adjuvant therapy: Beginning 4-8 weeks after completion of surgery, patients receive treatment (OxMdG or CAPOX with or without cetuximab) as in arm I or II of neoadjuvant therapy.
- Arm I: Treatment with OxMdG repeats every 2 weeks for up to 6 courses and treatment with CAPOX repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Treatment with OxMdG + cetuximab repeats every 2 weeks for up to 6 courses and treatment with CAPOX + cetuximab repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 12 weeks during chemotherapy, at completion of study treatment, every 3 months for 1 year, and then every 6 months thereafter.
Cost per life year and per quality-adjusted life year is assessed at baseline, every 12 weeks during treatment, and then at 3, 5, and 10 years.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Being tested
- cetuximab, capecitabine, fluorouracil, leucovorin calcium, oxaliplatin
- Keywords
- adenocarcinoma of the colon, stage IV colon cancer, adenocarcinoma of the rectum, stage IV rectal cancer, liver metastases, recurrent colon cancer, recurrent rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabBiological
capecitabineDrug
fluorouracilDrug
oxaliplatinDrug
study of socioeconomic and demographic variablesOther
adjuvant therapyProcedure or surgery
neoadjuvant therapyProcedure or surgery
quality-of-life assessmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| OxMdG / IrMdG chemotherapy | Active comparator | OxMdG / IrMdG chemotherapy for 12 weeks Followed by surgery OxMdG / IrMdG chemotherapy for 12 weeks Receives: Drug: capecitabine; Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Other: study of socioeconomic and demographic variables; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy; Procedure: quality-of-life assessment |
| OxMdG / IrMdG chemotherapy with cetuximab | Experimental | OxMdG / IrMdG chemotherapy with cetuximab for 12 weeks Followed by Surgery OxMdG / IrMdG chemotherapy with cetuximab for 12 weeks Receives: Biological: cetuximab; Drug: capecitabine; Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Other: study of socioeconomic and demographic variables; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: end of study
Secondary outcomes (7)
Response rate before surgery as assessed by RECIST criteria
Measured: end of study
Pathological resection status
Measured: end of study
Overall survival
Measured: end of study
Toxicity
Measured: end of study
Quality of life as assessed by the EQ-5D, EORTC QLQ-C30, and EORTC QLQ-LMC21
Measured: end of study
Cost effectiveness
Measured: end of study
Safety
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- John N. Primrose, MD, Study chair, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482222
- Sponsor's protocol ID
- CDR0000549541
- Other IDs
- USCTU-4351, USCTU-EPOC, EUDRACT-2006-003121-82, ISRCTN22944367, EU-20732
- Status last verified
- Apr 2008
- First submitted
- 4 Jun 2007
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Open Label Trial of Oxaliplatin/Fluoropyrimidine Versus Oxaliplatin/Fluoropyrimidine Plus Cetuximab Pre and Post Operatively in Patients With Resectable Colorectal Liver Metastasis Requiring Chemotherapy
- ClinicalTrials.gov ID
- NCT00482222
- Acronym / sponsor ID
- CDR0000549541
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Keywords
- adenocarcinoma of the colon, stage IV colon cancer, adenocarcinoma of the rectum, stage IV rectal cancer, liver metastases, recurrent colon cancer, recurrent rectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Study start
- Feb 2007
- Primary completion
- Dec 2014 (estimated)
- First posted
- 5 Jun 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: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without cetuximab in treating liver metastases caused by colorectal cancer.
PURPOSE: This randomized phase III trial is studying combination chemotherapy to compare how well it works when given with or without cetuximab before and after surgery in treating patients with resectable liver metastases caused by colorectal cancer.
Detailed description
OBJECTIVES:
Primary
- Compare progression-free survival of patients with resectable colorectal liver metastases treated with neoadjuvant and adjuvant combination chemotherapy with vs without cetuximab.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the cost effectiveness of these regimens in these patients.
OUTLINE: This is a prospective, randomized, multicenter, open-label study. Patients are stratified according to participating center and assigned chemotherapy regimen. Patients are randomized to 1 of 2 treatment arms.
- Neoadjuvant therapy:
- Arm I: Patients receive 1 of the following chemotherapy regimens:
- OxMdG: Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- CAPOX: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive 1 of the following regimens:
- OxMdG + cetuximab: Patients receive cetuximab IV over 1-2 hours on day 1 and OxMdG chemotherapy as in arm I. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- CAPOX + cetuximab: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and CAPOX chemotherapy as in arm I. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Surgery: Beginning 2-6 weeks after completion of chemotherapy, patients in both arms undergo liver resection.
- Adjuvant therapy: Beginning 4-8 weeks after completion of surgery, patients receive treatment (OxMdG or CAPOX with or without cetuximab) as in arm I or II of neoadjuvant therapy.
- Arm I: Treatment with OxMdG repeats every 2 weeks for up to 6 courses and treatment with CAPOX repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Treatment with OxMdG + cetuximab repeats every 2 weeks for up to 6 courses and treatment with CAPOX + cetuximab repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 12 weeks during chemotherapy, at completion of study treatment, every 3 months for 1 year, and then every 6 months thereafter.
Cost per life year and per quality-adjusted life year is assessed at baseline, every 12 weeks during treatment, and then at 3, 5, and 10 years.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OxMdG / IrMdG chemotherapy | Active comparator | Drug: capecitabine, Drug: fluorouracil, Drug: leucovorin calcium, Drug: oxaliplatin, Other: study of socioeconomic and demographic variables, Procedure: adjuvant therapy, Procedure: neoadjuvant therapy, Procedure: quality-of-life assessmentOxMdG / IrMdG chemotherapy for 12 weeks Followed by surgery OxMdG / IrMdG chemotherapy for 12 weeks |
| OxMdG / IrMdG chemotherapy with cetuximab | Experimental | Biological: cetuximab, Drug: capecitabine, Drug: fluorouracil, Drug: leucovorin calcium, Drug: oxaliplatin, Other: study of socioeconomic and demographic variables, Procedure: adjuvant therapy, Procedure: neoadjuvant therapy, Procedure: quality-of-life assessmentOxMdG / IrMdG chemotherapy with cetuximab for 12 weeks Followed by Surgery OxMdG / IrMdG chemotherapy with cetuximab for 12 weeks |
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 |
|---|---|---|
| cetuximab | Biological | OxMdG / IrMdG chemotherapy with cetuximab |
| capecitabine | Drug | OxMdG / IrMdG chemotherapy, OxMdG / IrMdG chemotherapy with cetuximab |
| fluorouracil | Drug | OxMdG / IrMdG chemotherapy, OxMdG / IrMdG chemotherapy with cetuximab |
| leucovorin calcium | Drug | OxMdG / IrMdG chemotherapy, OxMdG / IrMdG chemotherapy with cetuximab |
| oxaliplatin | Drug | OxMdG / IrMdG chemotherapy, OxMdG / IrMdG chemotherapy with cetuximab |
| study of socioeconomic and demographic variables | Other | OxMdG / IrMdG chemotherapy, OxMdG / IrMdG chemotherapy with cetuximab |
| adjuvant therapy | Procedure or surgery | OxMdG / IrMdG chemotherapy, OxMdG / IrMdG chemotherapy with cetuximab |
| neoadjuvant therapy | Procedure or surgery | OxMdG / IrMdG chemotherapy, OxMdG / IrMdG chemotherapy with cetuximab |
| quality-of-life assessment | Procedure or surgery | OxMdG / IrMdG chemotherapy, OxMdG / IrMdG chemotherapy with cetuximab |
Primary outcome
Progression-free survival
Time frame: end of study
7 secondary outcomes
Response rate before surgery as assessed by RECIST criteria
Time frame: end of study
Pathological resection status
Time frame: end of study
Overall survival
Time frame: end of study
Toxicity
Time frame: end of study
Quality of life as assessed by the EQ-5D, EORTC QLQ-C30, and EORTC QLQ-LMC21
Time frame: end of study
Cost effectiveness
Time frame: end of study
Safety
Time frame: end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 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.
Louisa Little contact
John N. Primrose, MD study chair
University Hospital Southampton NHS Foundation Trust
22 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 cetuximab, capecitabine and fluorouracil in people with Colorectal Cancer and Metastatic Cancer, run by University of Southampton at 22 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 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
Contact Louisa Little (02380795154), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: end of study). 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 23 Jan 2013.