Colorectal CancerARIESNCT00388206
A Study of Avastin in Combination With Chemotherapy for Treatment of Colorectal Cancer and Non-Small Cell Lung Cancer (ARIES)
An observational study of Colorectal Cancer and Non-Small Cell Lung Cancer, run by Genentech, Inc..
Trial summary
This is an observational study designed to follow patients with metastatic or locally advanced and unresectable CRC or locally advanced or metastatic NSCLC (excluding predominant squamous histology) who are receiving Avastin in combination with first-line chemotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer, Non-Small Cell Lung Cancer
- How many people
- 3,998 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Mar 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Signed Informed Consent Form
- Metastatic or locally advanced and unresectable CRC or locally advanced or metastatic NSCLC (excluding predominant squamous histology)
- Eligible for Avastin as a component of intended therapy
- First-line chemotherapy (or second-line chemotherapy for CRC) plus Avastin initiated ≤ 4 months prior to study enrollment
Who cannot join
- Any medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to provide informed consent or comply with the treatment and follow-up, as specified by the investigator
- Enrollment in a blinded, placebo-controlled bevacizumab trial
About this study
Official title: An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy for Treatment of Metastatic or Locally Advanced and Unresectable Colorectal Cancer and Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Excluding Predominant Squamous Cell Histology)
This is an observational study designed to follow patients with metastatic or locally advanced and unresectable CRC or locally advanced or metastatic NSCLC (excluding predominant squamous histology) who are receiving Avastin in combination with first-line chemotherapy. Second-line metastatic CRC patients are also eligible. Patients who started their Avastin containing therapy <4 months prior to enrollment are eligible.
- Conditions
- Colorectal Cancer, Non-Small Cell Lung Cancer
- Keywords
- NSCLC, Avastin, anti-VEGF, lung cancer, colorectal cancer, ARIES, Colon Cancer
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Colonic Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,998 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388206
- Sponsor's protocol ID
- AVF3991n
- Acronym
- ARIES
- Status last verified
- Dec 2022
- First submitted
- 12 Oct 2006
- Last updated
- 12 Dec 2022
- Results posted
- No
Publications
Wozniak AJ, Kosty MP, Jahanzeb M, Brahmer JR, Spigel DR, Leon L, Fish S, Flick ED, Hazard SJ, Lynch TJ Jr. Clinical outcomes in elderly patients with advanced non-small cell lung cancer: results from ARIES, a bevacizumab observational cohort study. Clin Oncol (R Coll Radiol). 2015 Apr;27(4):187-96. doi: 10.1016/j.clon.2014.12.002. Epub 2015 Jan 7.
PubMed 25576353Douillard JY, Ostoros G, Cobo M, Ciuleanu T, Cole R, McWalter G, Walker J, Dearden S, Webster A, Milenkova T, McCormack R. Gefitinib treatment in EGFR mutated caucasian NSCLC: circulating-free tumor DNA as a surrogate for determination of EGFR status. J Thorac Oncol. 2014 Sep;9(9):1345-53. doi: 10.1097/JTO.0000000000000263.
PubMed 25122430Lynch TJ Jr, Spigel DR, Brahmer J, Fischbach N, Garst J, Jahanzeb M, Kumar P, Vidaver RM, Wozniak AJ, Fish S, Flick ED, Leon L, Hazard SJ, Kosty MP; ARIES Study Investigators. Safety and effectiveness of bevacizumab-containing treatment for non-small-cell lung cancer: final results of the ARIES observational cohort study. J Thorac Oncol. 2014 Sep;9(9):1332-9. doi: 10.1097/JTO.0000000000000257.
PubMed 25122429
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy for Treatment of Metastatic or Locally Advanced and Unresectable Colorectal Cancer and Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Excluding Predominant Squamous Cell Histology)
- ClinicalTrials.gov ID
- NCT00388206
- Acronym / sponsor ID
- ARIES / AVF3991n
- Conditions
- Colorectal Cancer, Non-Small Cell Lung Cancer
- Keywords
- NSCLC, Avastin, anti-VEGF, lung cancer, colorectal cancer, ARIES, Colon Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,998 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2006 (actual)
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 16 Oct 2006 (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.
This is an observational study designed to follow patients with metastatic or locally advanced and unresectable CRC or locally advanced or metastatic NSCLC (excluding predominant squamous histology) who are receiving Avastin in combination with first-line chemotherapy. Second-line metastatic CRC patients are also eligible. Patients who started their Avastin containing therapy <4 months prior to enrollment are eligible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- Signed Informed Consent Form
- Metastatic or locally advanced and unresectable CRC or locally advanced or metastatic NSCLC (excluding predominant squamous histology)
- Eligible for Avastin as a component of intended therapy
- First-line chemotherapy (or second-line chemotherapy for CRC) plus Avastin initiated ≤ 4 months prior to study enrollment
Key exclusion criteria (2 listed)
- Any medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to provide informed consent or comply with the treatment and follow-up, as specified by the investigator
- Enrollment in a blinded, placebo-controlled bevacizumab trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 12 Dec 2022.
- Derived from this study: PubMed 25576353Wozniak AJ, Kosty MP, Jahanzeb M, Brahmer JR, Spigel DR, Leon L, Fish S, Flick ED, Hazard SJ, Lynch TJ Jr. Clinical outcomes in elderly patients with advanced non-small cell lung cancer: results from ARIES, a bevacizumab observational cohort study. Clin Oncol (R Coll Radiol). 2015 Apr;27(4):187-96. doi: 10.1016/j.clon.2014.12.002. Epub 2015 Jan 7.
- Derived from this study: PubMed 25122430Douillard JY, Ostoros G, Cobo M, Ciuleanu T, Cole R, McWalter G, Walker J, Dearden S, Webster A, Milenkova T, McCormack R. Gefitinib treatment in EGFR mutated caucasian NSCLC: circulating-free tumor DNA as a surrogate for determination of EGFR status. J Thorac Oncol. 2014 Sep;9(9):1345-53. doi: 10.1097/JTO.0000000000000263.
- Derived from this study: PubMed 25122429Lynch TJ Jr, Spigel DR, Brahmer J, Fischbach N, Garst J, Jahanzeb M, Kumar P, Vidaver RM, Wozniak AJ, Fish S, Flick ED, Leon L, Hazard SJ, Kosty MP; ARIES Study Investigators. Safety and effectiveness of bevacizumab-containing treatment for non-small-cell lung cancer: final results of the ARIES observational cohort study. J Thorac Oncol. 2014 Sep;9(9):1332-9. doi: 10.1097/JTO.0000000000000257.
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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.
Clinical Trials study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Non-Small Cell Lung Cancer, run by Genentech, Inc..
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 4 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: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00388206, which also lists 3 linked publications.
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 12 Dec 2022; AzTrials last refreshed its copy on 8 Nov 2026.