Colorectal Cancer MetastaticBEAMINGNCT01943786
RAS Switch in Patients With Metastatic RAS Native Colorectal Tumors Treated With 1st Line FOLFIRI-Cetuximab
An observational study of Colorectal Cancer Metastatic, run by Sofia Perea, Director Clinical Trials Unit. at 1 site in Spain.
Trial summary
Adenocarcinoma of the colon and rectum is a common, serious disease and it is the second cause of death from cancer in Spain. The prognosis of CRC depends to a great extent on its stage when diagnosed. Patients with advanced disease, who present up to 40% of all patients, have a poor prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- FOLFIRI + Cetuximab
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2013to Dec 2015
- Phase
- Observational
- 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
Study population: Patients with metastatic colorectal cáncer and wild-type KRAS treated with Folfiri-Cetuximab as first-line treatment.
Who may be able to join
- Diagnosis of stage IV colorectal adenocarcinoma.
- Patient ≥ 18 years of age.
- ECOG PS 0-1
- Life expectancy ≥ 6 months
- Candidate for first-line systemic chemotherapy according to regular clinical practice.
- Measurable disease.
- Wild-type KRAS
- Signed informed consent form.
Who cannot join
- Patient who has received prior chemotherapy for metastatic CRC, except for adjuvant treatment completed at least six months before entering study.
- Patient in whom there is a contraindication for the use of any of the drugs used in first-line treatment of colorectal cancer: 5-fluorouracil,, irinotecan or cetuximab
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro Integral Oncólógico Clara Campal (Madrid Norte Sanchinarro University Hospital)
Madrid, Madrid, 28050
About this study
Official title: Prospective, Non-Interventional Study of K-ras Status Switch in K-ras Native Patients With Metastatic Colorectal Tumors Treated With FOLFIRI-Cetuximab as First-line Treatment
Adenocarcinoma of the colon and rectum is a common, serious disease and it is the second cause of death from cancer in Spain.
The prognosis of CRC depends to a great extent on its stage when diagnosed. Patients with advanced disease, who present up to 40% of all patients, have a poor prognosis. Although the application of modern chemotherapy and radiotherapy treatments obtains median survival periods of around 24 months, the proportion of patients with advanced disease who obtain a cure is low.
Read more
Systemic treatment of advanced CRC has changed considerably in the last ten years with the introduction of active drugs such as oxaliplatin, irinotecan, and capecitabine. The most commonly used first line regimens are 5-Fluorouracil-Leucovorin-Oxaliplatin (FOLFOX), Capecitabine-Oxaliplatin (XELOX), 5-Fluorouracil-Leucovorin-Irinotecan (FOLFIRI) and, to a lesser extent, Capecitabine-Irinotecan (XELIRI). Chemotherapy regimens are combined with different agents against therapeutic targets, three of which are effective in colon cancer: bevacizumab, which targets vascular endothelial growth factor (VEGF) and cetuximab or panitumumab, which target the epidermal growth factor receptor (EGFR).
The use of cetuximab and panitumumab is not recommended in patients with KRAS mutations and the combination of a VEGF and EGFR agents is not beneficial.
Two recent studies results have identified KRAS mutations as frequent drivers of acquired resistance to cetuximab and panitumumab in colorectal cancer patients. The conclusions indicate that the emergence of KRAS mutant clones can be detected non-invasively months before radiographic progression by a DNA Blood Test (Inostics´BEAMing Technology).
Centro Integral Oncológico Clara Campal (CIOCC) is aiming to undertake a pioneer project aimed at integrating the analysis of KRAS switch status by BEAMing Technology in patients with metastatic colorectal cancer, tumor KRAS wild-type and BEAMing wild-type treated with first line FOLFIRI-cetuximab
In naive chemotherapy tumor-KRAS wild-type metastatic colorectal cancer patients, who are BEAMing positive (KRAS mutated in blood) before treatment may have worse evolution in terms of PFS (progression Free Survival) and response rate than BEAMing negative (KRAS native in blood) patients.
To know the proportion of patients who are BEAMing positive (KRAS mutation can be detected in circulating extracellular DNA) at the beginning of treatment, could be of great importance for treatment efficacy.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- FOLFIRI + Cetuximab
- Keywords
- Wild type KRAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRI + CetuximabDrug
Patients will receive study treatment (FOLFIRI + Cetuximab) according to regular clinical practice
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRI + Cetuximab | Patients with advanced colorectal cancer and wild-type KRAS will receive FOLFIRI + Cetuximab according to regular clinical practice Receives: Drug: FOLFIRI + Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the proportion of patients with advanced colorectal cancer in whom KRAS mutation can be detected in circulating extracellular DNA
Measured: Baseline
Secondary outcomes (7)
To estimate the proportion of patients with metastatic colorectal cancer who switch from BEAMing negative to BEAMing positive while being treated with first line FOLFIRI-Cetuximab
Measured: At 4 months and every eight weeks until disease progression up to 12 months
To estimate the response rate, in biopsy-proven K-ras wild-type patients according to KRAS status in circulating extracellular DNA.
Measured: Every eight weeks until disease progression up to 12 months
Disease control rate according to KRAS status in circulating extracellular DNA.
Measured: Every eight weeks until disease progression up to 12 months
Complete response rate according to KRAS status in circulating extracellular DNA.
Measured: Every eight weeks until disease progression up to 12 months
Duration of response according to KRAS status in circulating extracellular DNA.
From date of first documented response until de date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Measured: Every eight weeks until disease progression, up to 12 months
Early tumor shrinkage
Measured: At 4 months
Number of each adverse event per cycle
Measured: Every 2 weeks, until end of treatment, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sofia Perea, Director Clinical Trials Unit.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sofia Perea, Director Clinical Trials Unit., Grupo Hospital de Madrid
- Investigators
- Antonio Cubillo, Doctor, Principal investigator, Madrid Norte Sanchinarro University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943786
- Sponsor's protocol ID
- BEAMING
- Acronym
- BEAMING
- Status last verified
- Mar 2015
- First submitted
- 29 Apr 2013
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-Interventional Study of K-ras Status Switch in K-ras Native Patients With Metastatic Colorectal Tumors Treated With FOLFIRI-Cetuximab as First-line Treatment
- ClinicalTrials.gov ID
- NCT01943786
- Acronym / sponsor ID
- BEAMING / BEAMING
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- Wild type KRAS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sofia Perea, Director Clinical Trials Unit.University, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 17 Sep 2013 (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.
Adenocarcinoma of the colon and rectum is a common, serious disease and it is the second cause of death from cancer in Spain.
The prognosis of CRC depends to a great extent on its stage when diagnosed. Patients with advanced disease, who present up to 40% of all patients, have a poor prognosis. Although the application of modern chemotherapy and radiotherapy treatments obtains median survival periods of around 24 months, the proportion of patients with advanced disease who obtain a cure is low.
Systemic treatment of advanced CRC has changed considerably in the last ten years with the introduction of active drugs such as oxaliplatin, irinotecan, and capecitabine. The most commonly used first line regimens are 5-Fluorouracil-Leucovorin-Oxaliplatin (FOLFOX), Capecitabine-Oxaliplatin (XELOX), 5-Fluorouracil-Leucovorin-Irinotecan (FOLFIRI) and, to a lesser extent, Capecitabine-Irinotecan (XELIRI). Chemotherapy regimens are combined with different agents against therapeutic targets, three of which are effective in colon cancer: bevacizumab, which targets vascular endothelial growth factor (VEGF) and cetuximab or panitumumab, which target the epidermal growth factor receptor (EGFR).
The use of cetuximab and panitumumab is not recommended in patients with KRAS mutations and the combination of a VEGF and EGFR agents is not beneficial.
Two recent studies results have identified KRAS mutations as frequent drivers of acquired resistance to cetuximab and panitumumab in colorectal cancer patients. The conclusions indicate that the emergence of KRAS mutant clones can be detected non-invasively months before radiographic progression by a DNA Blood Test (Inostics´BEAMing Technology).
Centro Integral Oncológico Clara Campal (CIOCC) is aiming to undertake a pioneer project aimed at integrating the analysis of KRAS switch status by BEAMing Technology in patients with metastatic colorectal cancer, tumor KRAS wild-type and BEAMing wild-type treated with first line FOLFIRI-cetuximab
In naive chemotherapy tumor-KRAS wild-type metastatic colorectal cancer patients, who are BEAMing positive (KRAS mutated in blood) before treatment may have worse evolution in terms of PFS (progression Free Survival) and response rate than BEAMing negative (KRAS native in blood) patients.
To know the proportion of patients who are BEAMing positive (KRAS mutation can be detected in circulating extracellular DNA) at the beginning of treatment, could be of great importance for treatment efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFIRI + Cetuximab | – | Drug: FOLFIRI + CetuximabPatients with advanced colorectal cancer and wild-type KRAS will receive FOLFIRI + Cetuximab according to regular clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic colorectal cáncer and wild-type KRAS treated with Folfiri-Cetuximab as first-line treatment.
Key inclusion criteria (8 listed)
- Diagnosis of stage IV colorectal adenocarcinoma.
- Patient ≥ 18 years of age.
- ECOG PS 0-1
- Life expectancy ≥ 6 months
- Candidate for first-line systemic chemotherapy according to regular clinical practice.
Key exclusion criteria (2 listed)
- Patient who has received prior chemotherapy for metastatic CRC, except for adjuvant treatment completed at least six months before entering study.
- Patient in whom there is a contraindication for the use of any of the drugs used in first-line treatment of colorectal cancer: 5-fluorouracil,, irinotecan or cetuximab
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 |
|---|---|---|
| FOLFIRI + CetuximabPatients will receive study treatment (FOLFIRI + Cetuximab) according to regular clinical practice | Drug | FOLFIRI + Cetuximab |
Primary outcome
To estimate the proportion of patients with advanced colorectal cancer in whom KRAS mutation can be detected in circulating extracellular DNA
Time frame: Baseline
7 secondary outcomes
To estimate the proportion of patients with metastatic colorectal cancer who switch from BEAMing negative to BEAMing positive while being treated with first line FOLFIRI-Cetuximab
Time frame: At 4 months and every eight weeks until disease progression up to 12 months
To estimate the response rate, in biopsy-proven K-ras wild-type patients according to KRAS status in circulating extracellular DNA.
Time frame: Every eight weeks until disease progression up to 12 months
Disease control rate according to KRAS status in circulating extracellular DNA.
Time frame: Every eight weeks until disease progression up to 12 months
Complete response rate according to KRAS status in circulating extracellular DNA.
Time frame: Every eight weeks until disease progression up to 12 months
Duration of response according to KRAS status in circulating extracellular DNA.
Time frame: Every eight weeks until disease progression, up to 12 months
Early tumor shrinkage
Time frame: At 4 months
Number of each adverse event per cycle
Time frame: Every 2 weeks, until end of treatment, up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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CRC
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.
Antonio Cubillo, Doctor principal investigator
Madrid Norte Sanchinarro University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic, run by Sofia Perea, Director Clinical Trials Unit. at 1 site in Spain.
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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Mar 2015. 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 Spain. 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.
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?
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?
To estimate the proportion of patients with advanced colorectal cancer in whom KRAS mutation can be detected in circulating extracellular DNA (time frame: Baseline). 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 17 Mar 2015.