Adenocarcinoma of the ColonPhase 3NCT00070122
Combination Chemotherapy and Bevacizumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Colorectal Cancer
A Phase 3 study testing oxaliplatin, leucovorin calcium and capecitabine in people with Adenocarcinoma of the Colon and Adenocarcinoma of the Rectum, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Drugs used in chemotherapy, such as oxaliplatin, leucovorin, fluorouracil, and capecitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer
- What is being tested?
- oxaliplatin, leucovorin calcium and capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Jan 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed locally advanced, recurrent, or metastatic colorectal adenocarcinoma
- Not curable by surgery or amenable to radiotherapy with curative intent
- Previously resected colorectal cancer with new evidence of metastasis does not require separate histologic or cytologic confirmation unless one of the following is true:
- More than 5 years has elapsed between primary surgery and development of metastatic disease
- Primary tumor was T1-T2, N0, M0
- Site of primary lesion must be or have been in the large bowel as determined by endoscopy, radiology, or surgery
Show all 58Show fewer
- Measurable or evaluable disease
- No known brain or leptomeningeal disease
- Performance status - Zubrod 0-2
- No history of hemorrhagic or thrombotic disorders
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
- Bilirubin no greater than 2.0 times upper limit of normal (ULN)
- SGOT no greater than 2.5 times ULN (5 times ULN for patients with liver involvement)
- Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN for patients with liver involvement or 10 times ULN for patients with bone involvement)
- INR no greater than 1.5
- PTT no greater than ULN
- Creatinine no greater than 1.5 times ULN
- Creatinine clearance at least 50 mL/min
- Proteinuria less than 1+*
- Protein less than 500mg/24 hours*
- No uncontrolled hypertension
- Hypertension must be well-controlled (i.e., less than 160/90) and on a stable regimen of antihypertensive therapy
- No unstable angina
- No symptomatic congestive heart failure
- No myocardial infarction within the past 6 months
- No serious uncontrolled cardiac arrhythmia
- No New York Heart Association class III or IV heart disease
- No symptomatic pulmonary fibrosis
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
- No active or uncontrolled severe infection
- No contraindication to oral medications (e.g., severe dysphagia)
- G-tubes or J-tubes allowed
- No peripheral neuropathy greater than grade 1
- No serious non-healing wound, ulcer, or bone fracture
- No significant traumatic injury within the past 28 days
- No other severe acute or chronic medical condition or laboratory abnormality that would preclude study participation
- No psychiatric condition that would preclude study participation
- No prior bevacizumab
- No prior oxaliplatin
- No prior chemotherapy for advanced colorectal cancer
- Prior adjuvant therapy for resected stage II-III disease allowed provided at least 12 months have elapsed between completion of therapy and diagnosis of recurrent disease
- At least 28 days since prior radiotherapy and recovered
- See Disease Characteristics
- More than 28 days since prior major surgical procedure or open biopsy
- More than 7 days since prior fine needle aspiration or core biopsy
- No concurrent major surgery
- More than 10 days since prior full-dose aspirin (325 mg)
- No concurrent antiplatelet agents (e.g., dipyridamole, ticlopidine, clopidogrel, or cilostazol)
- No other concurrent investigational agents
- No concurrent therapeutic anticoagulation
- Prophylactic anticoagulation of central venous lines allowed
- Low-dose prophylactic enoxaparin or heparin allowed
- No concurrent cimetidine
- No concurrent sorivudine or its related analogs (e.g., brivudine)
- No concurrent use of a cold cap or iced mouth rinses
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Trial of Modified FOLFOX6 Versus CAPOX, With Bevacizumab (NSC-704865) or Placebo, as First-Line Therapy in Patients With Previously Untreated Advanced Colorectal Cancer
Drugs used in chemotherapy, such as oxaliplatin, leucovorin, fluorouracil, and capecitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen with bevacizumab works better in treating colorectal cancer. This randomized phase III trial is studying giving two different combination chemotherapy regimens together with bevacizumab and comparing how well they work in treating patients with locally advanced, metastatic, or recurrent colorectal cancer
Read the detailed description
OBJECTIVES:
- Compare overall survival in patients with locally advanced, metastatic, or recurrent colorectal cancer treated with fluorouracil, leucovorin calcium, oxaliplatin, and bevacizumab vs capecitabine, oxaliplatin, and bevacizumab.
II. Compare progression-free survival and time to treatment failure in patients treated with these regimens.
III. Compare the response of patients with measurable disease treated with these regimens.
IV.Compare toxicity rates of these regimens in these patients. V. Compare patient-reported functional status and convenience of therapy in patients treated with these regimens.
VI. Correlate germline polymorphisms of DNA repair (e.g., ERCC-1, XRCC1, GST-P1, XPD, and ribonucleotide reductase), target enzymes (e.g., thymidylate synthase, dihydropyrimidine dehydrogenase, and thymidine phosphorylase), angiogenesis (e.g., vascular endothelial growth factor), and growth factors (e.g., epithelial growth factor receptor) with survival, progression-free survival, and toxicity from chemotherapy in patients treated with these regimens.
VII. Correlate tumor mRNA expression levels of similar DNA repair enzymes as well as enzymes involved in angiogenesis with survival and progression-free survival in patients treated with these regimens.Correlate tumor mRNA expression levels of similar target enzymes before treatment with survival, progression-free survival, and toxicity in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Zubrod performance status (0 or 1 vs 2) and prior adjuvant therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours beginning on day 1. Patients are further randomized to receive bevacizumab or placebo* IV over 30-90 minutes on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *As of 11/15/04, placebo is no longer part of treatment plan; all patients receive bevacizumab.
ARM II: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine on days 1-15. Patients are further randomized to receive bevacizumab or placebo* as in arm I. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *As of 11/15/04, placebo is no longer part of treatment plan; all patients receive bevacizumab.
Patients are followed every 3 months until disease progression. After disease progression, patients are followed every 6 months for 2 years and then annually for up to 4 years after study entry.
PROJECTED ACCRUAL: A total of 2,200 patients (1,100 per treatment arm) will be accrued for this study within 3 years.
- Conditions
- Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage III Colon Cancer, Stage III Rectal Cancer
- Being tested
- oxaliplatin, leucovorin calcium, capecitabine, bevacizumab, fluorouracil
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatinDrug
Also called 1-OHP, Dacotin, Dacplat, Eloxatin
Given IV
Also called CF, CFR, LV
Given IV
capecitabineDrug
Also called CAPE, Ro 09-1978/000, Xeloda
Given orally
bevacizumabBiological
Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Given IV
fluorouracilDrug
Also called 5-fluorouracil, 5-Fluracil, 5-FU
Given IV
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (oxaliplatin, leucovorin calcium, fluorouracil) | Experimental | Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours beginning on day 1. Patients are further randomized to receive bevacizumab or placebo* IV over 30-90 minutes on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *As of 11/15/04, placebo is no longer part of treatment plan; all patients receive bevacizumab. Receives: Drug: oxaliplatin; Drug: leucovorin calcium; Biological: bevacizumab; Drug: fluorouracil; Other: laboratory biomarker analysis |
| Arm II (oxaliplatin, capecitabine) | Experimental | Patients receive oxaliplatin IV over 2 hours on day 1and oral capecitabine on days 1-15. Patients are further randomized to receive bevacizumab or placebo* as in arm I. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity NOTE: *As of 11/15/04, placebo is no longer part of treatment plan; all patients receive bevacizumab. Receives: Drug: oxaliplatin; Drug: capecitabine; Biological: bevacizumab; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival in patients with colorectal cancer treated with fluorouracil/leucovorin calcium and oxaliplatin with and without becavizumab versus those treated with capecitabine and oxaliplatin with our without bevacizumab
Will be analyzed primarily by the stratified Cox model.
Measured: Up to 6 years
Secondary outcomes (7)
Time to treatment failure
Will be analyzed primarily by the Cox stratified model.
Measured: Up to 6 years
Progression-free survival
Will be analyzed primarily by the Cox stratified model.
Measured: Up to 6 years
Response (among patients with measurable disease)
Will be analyzed primarily by the Cox stratified model.
Measured: Up to 6 years
Treatment toxicities graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 3.0)
Measured: Up to the time of progression
Change in FACT-C TOI
The analysis for evaluating this change will be a comparison of the change score between the first and last assessment. If cohort patterns for mean scores do not show signs of informative missing data, a mixed effects linear model approach will be used to measure change in FACT-C TOI scores.
Measured: Baseline to 25 weeks
Change in Chemotherapy Convenience and Satisfaction Questionnaire scores
Effect size will be used to compare the size of the difference in each arm.
Measured: Baseline to 25 weeks
Whether gene expression variables are predictive of survival and progression-free survival
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2003 (estimated)
- Study startApr 2004
- Primary completionJan 2007
Why it stopped: Administratively complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ColonStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Charles Blanke, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070122
- Sponsor's protocol ID
- NCI-2012-02556
- Other IDs
- S0303, U10CA032102, CDR0000330000
- Status last verified
- Jan 2013
- First submitted
- 3 Oct 2003
- Last updated
- 25 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial of Modified FOLFOX6 Versus CAPOX, With Bevacizumab (NSC-704865) or Placebo, as First-Line Therapy in Patients With Previously Untreated Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00070122
- Acronym / sponsor ID
- NCI-2012-02556
- Conditions
- Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage III Colon Cancer, Stage III Rectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively complete.
- Enrolment
- 2,200 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Apr 2004
- Primary completion
- Jan 2007 (actual)
- First posted
- 7 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Drugs used in chemotherapy, such as oxaliplatin, leucovorin, fluorouracil, and capecitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen with bevacizumab works better in treating colorectal cancer. This randomized phase III trial is studying giving two different combination chemotherapy regimens together with bevacizumab and comparing how well they work in treating patients with locally advanced, metastatic, or recurrent colorectal cancer
Detailed description
OBJECTIVES:
- Compare overall survival in patients with locally advanced, metastatic, or recurrent colorectal cancer treated with fluorouracil, leucovorin calcium, oxaliplatin, and bevacizumab vs capecitabine, oxaliplatin, and bevacizumab.
II. Compare progression-free survival and time to treatment failure in patients treated with these regimens.
III. Compare the response of patients with measurable disease treated with these regimens.
IV.Compare toxicity rates of these regimens in these patients. V. Compare patient-reported functional status and convenience of therapy in patients treated with these regimens.
VI. Correlate germline polymorphisms of DNA repair (e.g., ERCC-1, XRCC1, GST-P1, XPD, and ribonucleotide reductase), target enzymes (e.g., thymidylate synthase, dihydropyrimidine dehydrogenase, and thymidine phosphorylase), angiogenesis (e.g., vascular endothelial growth factor), and growth factors (e.g., epithelial growth factor receptor) with survival, progression-free survival, and toxicity from chemotherapy in patients treated with these regimens.
VII. Correlate tumor mRNA expression levels of similar DNA repair enzymes as well as enzymes involved in angiogenesis with survival and progression-free survival in patients treated with these regimens.Correlate tumor mRNA expression levels of similar target enzymes before treatment with survival, progression-free survival, and toxicity in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Zubrod performance status (0 or 1 vs 2) and prior adjuvant therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours beginning on day 1. Patients are further randomized to receive bevacizumab or placebo* IV over 30-90 minutes on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *As of 11/15/04, placebo is no longer part of treatment plan; all patients receive bevacizumab.
ARM II: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine on days 1-15. Patients are further randomized to receive bevacizumab or placebo* as in arm I. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *As of 11/15/04, placebo is no longer part of treatment plan; all patients receive bevacizumab.
Patients are followed every 3 months until disease progression. After disease progression, patients are followed every 6 months for 2 years and then annually for up to 4 years after study entry.
PROJECTED ACCRUAL: A total of 2,200 patients (1,100 per treatment arm) will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (oxaliplatin, leucovorin calcium, fluorouracil) | Experimental | Drug: oxaliplatin, Drug: leucovorin calcium, Biological: bevacizumab, Drug: fluorouracil, Other: laboratory biomarker analysisPatients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours beginning on day 1. Patients are further randomized to receive bevacizumab or placebo* IV over 30-90 minutes on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *As of 11/15/04, placebo is no longer part of treatment plan; all patients receive bevacizumab. |
| Arm II (oxaliplatin, capecitabine) | Experimental | Drug: oxaliplatin, Drug: capecitabine, Biological: bevacizumab, Other: laboratory biomarker analysisPatients receive oxaliplatin IV over 2 hours on day 1and oral capecitabine on days 1-15. Patients are further randomized to receive bevacizumab or placebo* as in arm I. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity NOTE: *As of 11/15/04, placebo is no longer part of treatment plan; all patients receive bevacizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (58 listed)
- Histologically or cytologically confirmed locally advanced, recurrent, or metastatic colorectal adenocarcinoma
- Site of primary lesion must be or have been in the large bowel as determined by endoscopy, radiology, or surgery
- Measurable or evaluable disease
- No known brain or leptomeningeal disease
- Performance status - Zubrod 0-2
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| oxaliplatinAlso: 1-OHP, Dacotin, Dacplat, EloxatinGiven IV | Drug | Arm I (oxaliplatin, leucovorin calcium, fluorouracil), Arm II (oxaliplatin, capecitabine) |
| leucovorin calciumAlso: CF, CFR, LVGiven IV | Drug | Arm I (oxaliplatin, leucovorin calcium, fluorouracil) |
| capecitabineAlso: CAPE, Ro 09-1978/000, XelodaGiven orally | Drug | Arm II (oxaliplatin, capecitabine) |
| bevacizumabAlso: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGFGiven IV | Biological | Arm I (oxaliplatin, leucovorin calcium, fluorouracil), Arm II (oxaliplatin, capecitabine) |
| fluorouracilAlso: 5-fluorouracil, 5-Fluracil, 5-FUGiven IV | Drug | Arm I (oxaliplatin, leucovorin calcium, fluorouracil) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (oxaliplatin, leucovorin calcium, fluorouracil), Arm II (oxaliplatin, capecitabine) |
Primary outcome
Overall survival in patients with colorectal cancer treated with fluorouracil/leucovorin calcium and oxaliplatin with and without becavizumab versus those treated with capecitabine and oxaliplatin with our without bevacizumab
Time frame: Up to 6 years
Will be analyzed primarily by the stratified Cox model.
7 secondary outcomes
Time to treatment failure
Time frame: Up to 6 years
Progression-free survival
Time frame: Up to 6 years
Response (among patients with measurable disease)
Time frame: Up to 6 years
Treatment toxicities graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 3.0)
Time frame: Up to the time of progression
Change in FACT-C TOI
Time frame: Baseline to 25 weeks
Change in Chemotherapy Convenience and Satisfaction Questionnaire scores
Time frame: Baseline to 25 weeks
Whether gene expression variables are predictive of survival and progression-free survival
Time frame: Up to 6 years
Results and safety
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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.
Charles Blanke principal investigator
SWOG Cancer Research Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oxaliplatin, leucovorin calcium and capecitabine in people with Adenocarcinoma of the Colon and Adenocarcinoma of the Rectum, run by National Cancer Institute (NCI) at 1 site in United States.
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 58 inclusion and 0 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: stopped early, as of the sponsor's last update on 25 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 1 site in United States. 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 was stopped early (reason given: Administratively complete.). Results are not available in the source record.
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 in patients with colorectal cancer treated with fluorouracil/leucovorin calcium and oxaliplatin with and without becavizumab versus those treated with capecitabine and oxaliplatin with our without bevacizumab (time frame: Up to 6 years). 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 25 Jan 2013.