Colorectal CancerPhase 2/3NCT00975897
Study of Tumor Tissue Testing in Selecting Treatment for Patients With Metastatic or Locally Advanced Colorectal Cancer
A Phase 2/3 study testing bevacizumab, cetuximab and fluorouracil in people with Colorectal Cancer, run by Medical Research Council at 3 sites in United Kingdom.
Trial summary
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors select the best treatment for patients and predict their response to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- bevacizumab, cetuximab and fluorouracil
- Type of treatment
- Surgery or procedure
- How many people
- 3,240 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jul 2009to Dec 2012
- Phase
- Phase 2/3
- 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 confirmed colorectal adenocarcinoma meeting 1 of the following criteria:
- Prior or recurrent primary adenocarcinoma of the colon or rectum with clinical or radiological evidence of locally advanced or metastatic disease
- Metastatic adenocarcinoma with clinical and/or radiological evidence of colorectal primary tumor
- Inoperable metastatic or locoregional disease
- Patients suitable for surgical resection of metastatic disease after response to first-line or adjuvant chemotherapy not allowed and should be considered for the New-EPOC trial study
- Unidimensionally measurable disease (according to RECIST criteria)
- Must have completed adjuvant chemotherapy with fluorouracil +/- leucovorin calcium (FU +/- LC), capecitabine, or oxaliplatin combinations in the past 6 months
- QUASAR 2 patients who have continued bevacizumab for 6 months following completion of chemotherapy are allowed immediately after completion of bevacizumab
- Rectal chemotherapy with FU +/- LC or capecitabine for allowed if completed ≥ 1 month ago
- Single tumor block available
- No brain metastasis
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
- Serum bilirubin ≤ 1.25 times ULN
- AST or ALT ≤ 2.5 times ULN
- Creatinine clearance ≥ 30 mL/min OR GFR ≥ 30 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Considered fit to undergo combination chemotherapy, with none of the following conditions:
- Severe uncontrolled concurrent medical illness likely to interfere with protocol treatments, including any of the following:
- Poorly controlled angina
- Uncontrolled hypertension
- Myocardial infarction within the past 3 months
- History of severe peptic ulcer disease
- Any psychiatric or neurological condition that is likely to compromise the patient's ability to give informed consent or to comply with oral medication
- Nephrotic syndrome
- Known coagulopathy
- No prior or current malignant disease that, in the judgement of the treating investigator, is likely to interfere with FOCUS 3 treatment or assessment of response
- No known hypersensitivity reactions to any of the components of the study treatments
- No personal or family history suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency or with known DPD deficiency
- No history of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant precluding informed consent
- Not able to attend or comply with treatment or follow-up scheduling
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior surgery
- No prior systemic chemotherapy for metastatic disease
- No ongoing therapy with cyclosporin-A
- No ongoing treatment with a contraindicated concomitant medication
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
Belfast, Northern Ireland, BT8 8JR
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
About this study
Official title: FOCUS 3 - A Study to Determine the Feasibility of Molecular Selection of Therapy Using KRAS, BRAF and Topo-1 in Patients With Metastatic or Locally Advanced Colorectal Cancer
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors select the best treatment for patients and predict their response to treatment.
PURPOSE: This randomized phase II/III trial is studying how well tumor tissue testing works in selecting treatment for patients with metastatic or locally advanced colorectal cancer.
Read the detailed description
OBJECTIVES:
Primary - Feasibility Study
- To determine the proportion of consenting patients that can provide a formalin-fixed paraffin-embedded block containing tumor.
- To determine the feasibility of topoisomerase-1 (topo-1) IHC and K-ras, BRAF mutational status determination being completed with 10 working days of initial consent.
- To determine reproducibility of results between reference laboratories.
- To determine the real costs of molecular testing.
- To determine the patients' ability to comprehend the study and their attitude during the waiting period for testing.
- To assess patients' ability to fully comprehend the trial as explained to them.
Secondary - Feasibility Study
- To further identify the EGFR-responsive subset within the K-ras wildtype population.
Primary - Definitive Study
- Compare the clinical outcomes of patients with metastatic or locally advanced colorectal cancer and low topo-1-expressing tumors treated with fluorouracil alone versus irinotecan hydrochloride, fluorouracil, and leucovorin calcium (IrMdG).
- Compare the progression-free survival of patients with high topo-1-expressing tumors treated with oxaliplatin and IrMdG versus IrMdG alone.
- Compare the response rate in patients with K-ras wildtype tumor treated with cetuximab and IrMdG versus IrMdG alone.
- Compare the response rate in patients with K-ras mutant tumors who are unlikely to respond to EGFR inhibition treated with bevacizumab and IrMdG versus IrMdG alone.
OUTLINE: This is a multicenter, 2-part study.
- Part I (feasibility study): Once consent for tissue block release has been obtained and patient is registered, the block is requested from the Pathology Department. This begins the 10 working-day time line. Treatment commences once the results of the testing are known. The following evaluations are performed during this period:
- The frequency of EGFR gene amplification on FISH, PI3K gene mutation, PTEN loss by IHC, estimation of mRNA for EGFR ligands (amphiregulin and epiregulin), and other protein assessments.
- An evaluation of the impact on the use or further investigation of these markers in the main study.
- Patients consenting to trial entry and (if agreeable to data collection) patients refusing trial entry complete a questionnaire assessing patients' ability to fully comprehend the trial as explained to them.
- Patients are interviewed before allocation of treatment about their attitudes about the waiting period necessary for tumor testing.
- Part II (definitive study): Patients are stratified according to availability of both lab tests (K-ras mutation [yes vs no], BRAF mutation [yes vs no], and topoisomerase-1 [topo-1] expression [low vs high]). Patients are assigned to 1 of 4 treatment groups based on their biomarker test results.
- Group 1 (low topo-1 and both K-ras and BRAF wildtype): Patients are randomized to 1 of 3 treatment arms.
- Arm I (regimen A [IrMdG]): Patients receive irinotecan hydrochloride IV over 30 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV bolus followed by infusion over 46 hours on day 1. Treatment repeats every 2 weeks for at least 6 months in the absence of disease progression or unacceptable toxicity.
- Arm II (regimen B [MdG]): Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV bolus followed by infusion over 46 hours on day 1. Treatment repeats every 2 weeks for at least 6 months in the absence of disease progression or unacceptable toxicity.
- Arm III (regimen D [IrMdG and cetuximab]): Patients receive cetuximab IV over 1-2 hours, irinotecan hydrochloride IV over 30 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV bolus followed by infusion over 46 hours on day 1. Treatment repeats every 2 weeks for at least 6 months in the absence of disease progression or unacceptable toxicity.
- Group 2 (low topo-1 and either K-ras or BRAF mutation): Patients are randomized to 1 of 3 treatment arms.
- Arm I (regimen A [IrMdG]): Patients receive irinotecan hydrochloride, leucovorin calcium, and fluorouracil as in group 1, arm I.
- Arm II (regimen B [MdG]): Patients receive leucovorin calcium and fluorouracil as in group 1, arm II.
- Arm III (regimen E [IrMdG and bevacizumab]): Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV over 30 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV bolus followed by infusion over 46 hours on day 1. Treatment repeats every 2 weeks for at least 6 months in the absence of disease progression or unacceptable toxicity.
- Group 3 (high topo-1 and both K-ras and BRAF wildtype): Patients are randomized to 1 of 3 treatment arms.
- Arm I (regimen A [IrMdG]): Patients receive irinotecan hydrochloride, leucovorin calcium, and fluorouracil as in group 1, arm I.
- Arm II (regimen C [IrOxMdG]): Patients receive irinotecan hydrochloride IV over 30 minutes, leucovorin calcium IV over 2 hours, oxaliplatin IV over 2 hours, and fluorouracil IV bolus followed by infusion over 46 hours on day 1. Treatment repeats every 2 weeks for at least 6 months in the absence of disease progression or unacceptable toxicity.
- Arm III (regimen D [IrMdG and cetuximab]): Patients receive cetuximab, irinotecan hydrochloride, leucovorin calcium, and fluorouracil IV as in group 1, arm III.
- Group 4 (high topo-1 and either K-ras or BRAF mutation): Patients are randomized to 1 of 3 treatment arms.
- Arm I (regimen A [IrMdG]): Patients receive irinotecan hydrochloride, leucovorin calcium, and fluorouracil as in group 1, arm I.
- Arm II (regimen C [IrOxMdG]): Patients receive irinotecan hydrochloride, leucovorin calcium, oxaliplatin, and fluorouracil as in group 3, arm II.
- Arm III (regimen E [IrMdG and bevacizumab]): Patients receive bevacizumab, irinotecan hydrochloride, leucovorin calcium, and fluorouracil IV as group 2, arm III.
After completion of study therapy, patients are followed up periodically.
PROJECTED ACCRUAL: A total of 240 patients will be accrued for the feasibility study and approximately 3,000 patients will be accrued for the definitive study.
- Conditions
- Colorectal Cancer
- Being tested
- bevacizumab, cetuximab, fluorouracil, irinotecan hydrochloride, leucovorin calcium
- Keywords
- adenocarcinoma of the colon, recurrent colon cancer, stage III colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabBiological
cetuximabBiological
fluorouracilDrug
oxaliplatinDrug
RNA analysisGenetic
cytogenetic analysisGenetic
fluorescence in situ hybridizationGenetic
gene expression analysisGenetic
mutation analysisGenetic
protein expression analysisGenetic
diagnostic laboratory biomarker analysisOther
questionnaire administrationOther
cognitive assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Topoisomerase-1 (topo-1) and K-ras, BRAF results obtained within 10 working days after registration
Number of patients in which the interval between registration and randomization (RZ) is ≤ 10 days
Efficacy of fluorouracil with vs without irinotecan hydrochloride, fluorouracil, and leucovorin calcium (IrMdG) in low topo-1 tumors
Progression-free survival of patients with high topo-1 tumors treated with IrMdG with or without oxaliplatin
Efficacy of IrMdG with vs without cetuximab in K-ras wildtype tumors
Efficacy of IrMdG with vs without bevacizumab in K-ras mutant tumors
Secondary outcomes (11)
Time from release of tumor block to receipt by pathology lab
If applicable, reason that RZ did not occur
Time from registration to treatment start
Time from data presentation to investigator to date of RZ
Reproducibility of K-ras, BRAF, and topo-1 results
Distribution frequencies
Costs of molecular testing
Toxicity according to NCI CTCAE v.3
Response rates
Progression-free survival
Attitudes of patients about tests and treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2010
- Study completionDec 2012
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 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 3,240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Investigators
- Timothy Maughan, MD, Principal investigator, Velindre NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975897
- Sponsor's protocol ID
- CDR0000648235
- Other IDs
- UKM-MRC-FOCUS3-CR12, EUDRACT-2008-008323-15, ISRCTN83171665, EU-20960
- Status last verified
- Aug 2011
- First submitted
- 11 Sep 2009
- Last updated
- 19 Dec 2013
- Results posted
- No
Publications
Maughan T, Wilson RH, Williams GT, et al.: Developing a biomarker-stratified trial design in advanced colorectal cancer: The MRC FOCUS 3 feasibility study. [Abstract] J Clin Oncol 29 (Suppl 15): A-TPS165, 2011.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOCUS 3 - A Study to Determine the Feasibility of Molecular Selection of Therapy Using KRAS, BRAF and Topo-1 in Patients With Metastatic or Locally Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00975897
- Acronym / sponsor ID
- CDR0000648235
- Conditions
- Colorectal Cancer
- Keywords
- adenocarcinoma of the colon, recurrent colon cancer, stage III colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,240 participants (estimated)
- Lead sponsor
- Medical Research CouncilOther government
- Study start
- Jul 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Sep 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.
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors select the best treatment for patients and predict their response to treatment.
PURPOSE: This randomized phase II/III trial is studying how well tumor tissue testing works in selecting treatment for patients with metastatic or locally advanced colorectal cancer.
Detailed description
OBJECTIVES:
Primary - Feasibility Study
- To determine the proportion of consenting patients that can provide a formalin-fixed paraffin-embedded block containing tumor.
- To determine the feasibility of topoisomerase-1 (topo-1) IHC and K-ras, BRAF mutational status determination being completed with 10 working days of initial consent.
- To determine reproducibility of results between reference laboratories.
- To determine the real costs of molecular testing.
- To determine the patients' ability to comprehend the study and their attitude during the waiting period for testing.
- To assess patients' ability to fully comprehend the trial as explained to them.
Secondary - Feasibility Study
- To further identify the EGFR-responsive subset within the K-ras wildtype population.
Primary - Definitive Study
- Compare the clinical outcomes of patients with metastatic or locally advanced colorectal cancer and low topo-1-expressing tumors treated with fluorouracil alone versus irinotecan hydrochloride, fluorouracil, and leucovorin calcium (IrMdG).
- Compare the progression-free survival of patients with high topo-1-expressing tumors treated with oxaliplatin and IrMdG versus IrMdG alone.
- Compare the response rate in patients with K-ras wildtype tumor treated with cetuximab and IrMdG versus IrMdG alone.
- Compare the response rate in patients with K-ras mutant tumors who are unlikely to respond to EGFR inhibition treated with bevacizumab and IrMdG versus IrMdG alone.
OUTLINE: This is a multicenter, 2-part study.
- Part I (feasibility study): Once consent for tissue block release has been obtained and patient is registered, the block is requested from the Pathology Department. This begins the 10 working-day time line. Treatment commences once the results of the testing are known. The following evaluations are performed during this period:
- The frequency of EGFR gene amplification on FISH, PI3K gene mutation, PTEN loss by IHC, estimation of mRNA for EGFR ligands (amphiregulin and epiregulin), and other protein assessments.
- An evaluation of the impact on the use or further investigation of these markers in the main study.
- Patients consenting to trial entry and (if agreeable to data collection) patients refusing trial entry complete a questionnaire assessing patients' ability to fully comprehend the trial as explained to them.
- Patients are interviewed before allocation of treatment about their attitudes about the waiting period necessary for tumor testing.
- Part II (definitive study): Patients are stratified according to availability of both lab tests (K-ras mutation [yes vs no], BRAF mutation [yes vs no], and topoisomerase-1 [topo-1] expression [low vs high]). Patients are assigned to 1 of 4 treatment groups based on their biomarker test results.
- Group 1 (low topo-1 and both K-ras and BRAF wildtype): Patients are randomized to 1 of 3 treatment arms.
- Arm I (regimen A [IrMdG]): Patients receive irinotecan hydrochloride IV over 30 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV bolus followed by infusion over 46 hours on day 1. Treatment repeats every 2 weeks for at least 6 months in the absence of disease progression or unacceptable toxicity.
- Arm II (regimen B [MdG]): Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV bolus followed by infusion over 46 hours on day 1. Treatment repeats every 2 weeks for at least 6 months in the absence of disease progression or unacceptable toxicity.
- Arm III (regimen D [IrMdG and cetuximab]): Patients receive cetuximab IV over 1-2 hours, irinotecan hydrochloride IV over 30 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV bolus followed by infusion over 46 hours on day 1. Treatment repeats every 2 weeks for at least 6 months in the absence of disease progression or unacceptable toxicity.
- Group 2 (low topo-1 and either K-ras or BRAF mutation): Patients are randomized to 1 of 3 treatment arms.
- Arm I (regimen A [IrMdG]): Patients receive irinotecan hydrochloride, leucovorin calcium, and fluorouracil as in group 1, arm I.
- Arm II (regimen B [MdG]): Patients receive leucovorin calcium and fluorouracil as in group 1, arm II.
- Arm III (regimen E [IrMdG and bevacizumab]): Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV over 30 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV bolus followed by infusion over 46 hours on day 1. Treatment repeats every 2 weeks for at least 6 months in the absence of disease progression or unacceptable toxicity.
- Group 3 (high topo-1 and both K-ras and BRAF wildtype): Patients are randomized to 1 of 3 treatment arms.
- Arm I (regimen A [IrMdG]): Patients receive irinotecan hydrochloride, leucovorin calcium, and fluorouracil as in group 1, arm I.
- Arm II (regimen C [IrOxMdG]): Patients receive irinotecan hydrochloride IV over 30 minutes, leucovorin calcium IV over 2 hours, oxaliplatin IV over 2 hours, and fluorouracil IV bolus followed by infusion over 46 hours on day 1. Treatment repeats every 2 weeks for at least 6 months in the absence of disease progression or unacceptable toxicity.
- Arm III (regimen D [IrMdG and cetuximab]): Patients receive cetuximab, irinotecan hydrochloride, leucovorin calcium, and fluorouracil IV as in group 1, arm III.
- Group 4 (high topo-1 and either K-ras or BRAF mutation): Patients are randomized to 1 of 3 treatment arms.
- Arm I (regimen A [IrMdG]): Patients receive irinotecan hydrochloride, leucovorin calcium, and fluorouracil as in group 1, arm I.
- Arm II (regimen C [IrOxMdG]): Patients receive irinotecan hydrochloride, leucovorin calcium, oxaliplatin, and fluorouracil as in group 3, arm II.
- Arm III (regimen E [IrMdG and bevacizumab]): Patients receive bevacizumab, irinotecan hydrochloride, leucovorin calcium, and fluorouracil IV as group 2, arm III.
After completion of study therapy, patients are followed up periodically.
PROJECTED ACCRUAL: A total of 240 patients will be accrued for the feasibility study and approximately 3,000 patients will be accrued for the definitive study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Masking
- None (open label)
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 |
|---|---|---|
| bevacizumab | Biological | – |
| cetuximab | Biological | – |
| fluorouracil | Drug | – |
| irinotecan hydrochloride | Drug | – |
| leucovorin calcium | Drug | – |
| oxaliplatin | Drug | – |
| RNA analysis | Genetic | – |
| cytogenetic analysis | Genetic | – |
| fluorescence in situ hybridization | Genetic | – |
| gene expression analysis | Genetic | – |
| mutation analysis | Genetic | – |
| protein expression analysis | Genetic | – |
| diagnostic laboratory biomarker analysis | Other | – |
| immunohistochemistry staining method | Other | – |
| questionnaire administration | Other | – |
| cognitive assessment | Procedure or surgery | – |
Primary outcome
Topoisomerase-1 (topo-1) and K-ras, BRAF results obtained within 10 working days after registration
Number of patients in which the interval between registration and randomization (RZ) is ≤ 10 days
Efficacy of fluorouracil with vs without irinotecan hydrochloride, fluorouracil, and leucovorin calcium (IrMdG) in low topo-1 tumors
Progression-free survival of patients with high topo-1 tumors treated with IrMdG with or without oxaliplatin
Efficacy of IrMdG with vs without cetuximab in K-ras wildtype tumors
Efficacy of IrMdG with vs without bevacizumab in K-ras mutant tumors
11 secondary outcomes
Time from release of tumor block to receipt by pathology lab
If applicable, reason that RZ did not occur
Time from registration to treatment start
Time from data presentation to investigator to date of RZ
Reproducibility of K-ras, BRAF, and topo-1 results
Distribution frequencies
Costs of molecular testing
Toxicity according to NCI CTCAE v.3
Response rates
Progression-free survival
Attitudes of patients about tests and treatment
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 19 Dec 2013.
- Results publicationMaughan T, Wilson RH, Williams GT, et al.: Developing a biomarker-stratified trial design in advanced colorectal cancer: The MRC FOCUS 3 feasibility study. [Abstract] J Clin Oncol 29 (Suppl 15): A-TPS165, 2011.
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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.
Timothy Maughan, MD principal investigator
Velindre NHS Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing bevacizumab, cetuximab and fluorouracil in people with Colorectal Cancer, run by Medical Research Council at 3 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: finished, as of the sponsor's last update on 19 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 3 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 combined 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.
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?
Topoisomerase-1 (topo-1) and K-ras, BRAF results obtained within 10 working days after registration. The study lists 6 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 NCT00975897, 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 19 Dec 2013.