Adenocarcinoma of ColonPhase 2NCT01703910
Study of Individualized Therapies Selection for Patients With Metastatic Colorectal Carcinoma According to the Therapeutic
A Phase 2 study testing Arm A chemotherapy and arm B chemotherapy in people with Adenocarcinoma of Colon and Adenocarcinoma of Rectum, run by Centro Nacional de Investigaciones Oncologicas CARLOS III at 2 sites in Spain.
Trial summary
The purpose of this study is to assess the feasibility of selecting personalized therapies for colon cancer patients who have failed standard treatments, using a new methodology based on the determination of a profile of chemosensitivity by comprehensive genetic expression analysis from tumor samples. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Adenocarcinoma of Colon, Adenocarcinoma of Rectum, Metastatic Disease
- What is being tested?
- Arm A chemotherapy and arm B chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesSpain
- Study dates
- Nov 2012to Dec 2014
- Phase
- Phase 2
- 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 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological examination showed of metastatic colon carcinoma.
- Patients more than 18 years.
- Measurable disease according to RECIST 1.1 criteriso
- Life expectancymore than 3 months according to the criteria of the investigator.
- Goodoverall condition determined by the ECOG scale (score 0-1)
- Candidate for systemic treatment based on the profile of sensibility to drugs determined by genetic analysis of the tumor sample. Patients should have received at least two lines of standard treatment, including therapies antiEGFR in cases of tumors with Kras oncogene B-Raf and native (non-mutated).
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- Availability of tumor tissue or potential for tumor biopsy correlation allowing the RNA expression profile with that obtained from the peripheral blood CTCs.
- Adequate hematologic function: ANCmore than 1.5 x 103 / L, platelet count absolute more than 100 x 109 / L, normal values of INR and PTT.
- Adequate liver function: total serum bilirubin no more than 2 mg / dL, ALT and AST no more than 3 times the upper limit established by the laboratory (LSR) or no more than 5 LSR in patients with liver metastases.
- Adequate renal function: serum creatinine no more than 1.5 LSR or calculated creatinine clearance 60 ml / min (Crock).
Who cannot join
- The patient has received systemic cancer treatment within two weeks prior to extraction of the blood sample.
- Patient has received therapeutic radioisotopes such as strontium 89 within 4 weeks before blood extraction.
- Patient has had major surgery or percutaneous procedures such as placement of central venous catheter within 2 weeks prior to the blood draw.
- Patient has a history as bone marrow transplantation and / or stem cell transplantation.
- Patient has any of the following concomitant diseases or current conditions:
- chronic active liver disease of any origin, and / or cirrhosis with Child-Pugh score B or C.
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- Uncontrolled active infection. carries the human immunodeficiency virus (HIV). Any other significant disease that in the opinion of the investigator, substantially increase the risk associated with patient participation in this study.
- documented symptomatic brain metastases, progression or requiring corticosteroids or associated to a leptomeningeal involvement.
- Patients with uncontrolled systemic diseases. Patients with Hypertension or Diabetes Mellitus is countable if at the time of inclusion deemed medically controlled.
- Patients with inability for oral drug delivery, either by preventing gastrointestinal administration situation or severe impairment of intestinal absorption
- Any medical or psychiatric condition that, in the opinion of the investigator, may limit the patient's ability to understand and fulfill all requirements under its partcipación in the study.
- Pregnant or lactating women
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28950
Hospital Madrid Norte Sanchinarro
Madrid, Madrid, 28050
About this study
Official title: Phase II Individualized Therapies Selection Study for Patients With Metastatic Colorectal Carcinoma According to the Genomic Expression Profile in Tumor Samples.
The purpose of this study is to assess the feasibility of selecting personalized therapies for colon cancer patients who have failed standard treatments, using a new methodology based on the determination of a profile of chemosensitivity by comprehensive genetic expression analysis from tumor samples.
Read the detailed description
It is a prospective, randomized study in patients with metastatic colorectal carcinoma progressing after two lines of prior therapy. Patients will be randomized (1:1) to receive chemotherapy as determined by its oncologist or treatment according to chemosensitivity profile obtained. For obtaining the profile a histological tumor sample and a sample of venous blood in a tube with heparin standard are necessary . This latter sample will be processed to isolate circulating tumor cells by cell adhesion with matrix coated glass spheres. The RNA from these circulating tumor cells as well as from tumor cells of tumor biopsies from the same patients will be extracted by a standard procedure for extracting RNA for genetic expression analysis. Based on the analysis performed on tumor biopsy is generated a ranked list of potentially more effective treatments in every case
- Being tested
- Arm A chemotherapy, arm B chemotherapy
- Keywords
- Genomic expression profile in tumor samples, Adult patients, metastatic disease status and progression after two lines of systemic therapy
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm A chemotherapyDrug
Also called Capecitabine, Cisplatin, Cetuximab, Doxorubicin
arm B chemotherapyDrug
Also called Capecitabine, Cisplatin, Cetuximab, Doxorubicin
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Control treatment and will be treated with any of the schemes used in the study according to the discretion of the physician. Receives: Drug: Arm A chemotherapy |
| Arm B | Experimental | Treatment guided by the gene expression profiles obtained from the CTC Receives: Drug: arm B chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
To determine the tumor progression-free survival at 3 and 6 months (PFS3 and PFS6) in both groups of patients and identify whether there is a statistically significant difference
Measured: 12 months
gene expression profiles
Assess the correlation between the gene expression profiles obtained from the CTC and the gene expression profiles obtained from tumor samples from the same patients.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of ColonStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Nacional de Investigaciones Oncologicas CARLOS III
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario de Fuenlabrada, Grupo Hospital de Madrid, Apices Soluciones S.L.
- Responsible party
- Sponsor
- Investigators
- Carlos Gómez, M.D.,Ph.D, Study director, Centro Nacional de Investigaciones Oncológicas (CNIO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703910
- Sponsor's protocol ID
- CNIO-GI-01-2012
- Status last verified
- Oct 2015
- First submitted
- 8 Oct 2012
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Individualized Therapies Selection Study for Patients With Metastatic Colorectal Carcinoma According to the Genomic Expression Profile in Tumor Samples.
- ClinicalTrials.gov ID
- NCT01703910
- Acronym / sponsor ID
- CNIO-GI-01-2012
- Keywords
- Genomic expression profile in tumor samples, Adult patients, metastatic disease status and progression after two lines of systemic therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Centro Nacional de Investigaciones Oncologicas CARLOS IIIUniversity, hospital or other
- Collaborators
- Hospital Universitario de Fuenlabrada, Grupo Hospital de Madrid, Apices Soluciones S.L.
- Study start
- Nov 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Oct 2012 (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.
The purpose of this study is to assess the feasibility of selecting personalized therapies for colon cancer patients who have failed standard treatments, using a new methodology based on the determination of a profile of chemosensitivity by comprehensive genetic expression analysis from tumor samples.
Detailed description
It is a prospective, randomized study in patients with metastatic colorectal carcinoma progressing after two lines of prior therapy. Patients will be randomized (1:1) to receive chemotherapy as determined by its oncologist or treatment according to chemosensitivity profile obtained. For obtaining the profile a histological tumor sample and a sample of venous blood in a tube with heparin standard are necessary . This latter sample will be processed to isolate circulating tumor cells by cell adhesion with matrix coated glass spheres. The RNA from these circulating tumor cells as well as from tumor cells of tumor biopsies from the same patients will be extracted by a standard procedure for extracting RNA for genetic expression analysis. Based on the analysis performed on tumor biopsy is generated a ranked list of potentially more effective treatments in every case
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Arm A chemotherapyControl treatment and will be treated with any of the schemes used in the study according to the discretion of the physician. |
| Arm B | Experimental | Drug: arm B chemotherapyTreatment guided by the gene expression profiles obtained from the CTC |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histological examination showed of metastatic colon carcinoma.
- Patients more than 18 years.
- Measurable disease according to RECIST 1.1 criteriso
- Life expectancymore than 3 months according to the criteria of the investigator.
- Goodoverall condition determined by the ECOG scale (score 0-1)
Key exclusion criteria (12 listed)
- The patient has received systemic cancer treatment within two weeks prior to extraction of the blood sample.
- Patient has received therapeutic radioisotopes such as strontium 89 within 4 weeks before blood extraction.
- Patient has had major surgery or percutaneous procedures such as placement of central venous catheter within 2 weeks prior to the blood draw.
- Patient has a history as bone marrow transplantation and / or stem cell transplantation.
- Patient has any of the following concomitant diseases or current conditions:
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 |
|---|---|---|
| Arm A chemotherapyAlso: Capecitabine, Cisplatin, Cetuximab, Doxorubicin | Drug | Arm A |
| arm B chemotherapyAlso: Capecitabine, Cisplatin, Cetuximab, Doxorubicin | Drug | Arm B |
Primary outcome
Overall survival
Time frame: 12 months
To determine the tumor progression-free survival at 3 and 6 months (PFS3 and PFS6) in both groups of patients and identify whether there is a statistically significant difference
gene expression profiles
Time frame: 12 months
Assess the correlation between the gene expression profiles obtained from the CTC and the gene expression profiles obtained from tumor samples from the same patients.
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 9 Oct 2015.
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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.
Carlos Gómez, M.D.,Ph.D study director
Centro Nacional de Investigaciones Oncológicas (CNIO)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arm A chemotherapy and arm B chemotherapy in people with Adenocarcinoma of Colon and Adenocarcinoma of Rectum, run by Centro Nacional de Investigaciones Oncologicas CARLOS III at 2 sites 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 10 inclusion and 12 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: finished, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this 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.
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?
Overall survival (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2015.