First-line Combination of Capecitabine and Oxaliplatin Plus Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer (COBRA)

April 14, 2026 updated by: Istituto Oncologico Veneto IRCCS

First-line Combination of Capecitabine and Oxaliplatin + Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer

  • Oxaliplatin-based doublets plus bevacizumab are standard first-line therapy options for patients (pts) with metastatic colorectal cancer (mCRC). Slight adjustments in chemo-dosage are commonly applied in routinely practice to elderly pts, but those modified schedules have never been standardized
  • The addition of oxaliplatin versus no oxaliplatin to treatment with 5-fluorouracil in older and frail untreated pts with mCRC resulted in a non-statistically significant trend toward improvement in Progression Free Survival (PFS) and a lack of benefit in Overall Survival (OS)
  • In elderly pts deemed unfit for an upfront combined chemotherapy a fluoropyrimide-based monotherapy plus bevacizumab is considered a reasonable first-line treatment
  • Clinical definition of elderly (over 70 years old) pts with CRC that may deserve a more or less intensive combination therapy is still debated. The cut-off of 75 years old combined with ECOG PS assessment is a reasonable approach for clearly defining candidates to different approaches
  • Several geriatric screening tools have been used to identify pts with a geriatric profile potentially predicting for overall survival and risk of toxicity. The G8 screening tool has been already validated in pts with cancer showing the strongest prognostic value for OS; the CRASH score is able to stratify pts according an estimated risk of treatment-related toxicities

On the basis of these considerations, we designed the present observational study of first-line therapy with bevacizumab in combination with capecitabine and oxaliplatin in previously untreated elderly pts affected by unresectable mCRC in order to evaluate its efficacy in real world practice (as measured by progression free survival)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padua, Italy, 35128
        • Istituto Oncologico Veneto IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

66 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Elderly (> 70 years) patients with metastatic colorectal cancer

Description

Inclusion Criteria:

  • Histologically proven diagnosis of colorectal cancer.
  • Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease.
  • Indication to oxaliplatin, capecitabine and bevacizumab as first line treatment.
  • At least one measurable lesion according to RECIST1.1 criteria.
  • Availability of a tumoral sample (primary and/or metastatic sites).
  • Age ≥ 70 years.
  • ECOG PS (Eastern Cooperative Oncology Group - Performance Status) 1 or 2 for pts aged 70 to 75 years; ECOG PS 0 or 1 for pts aged > 75 years.
  • Life expectancy of at least 12 weeks.
  • Previous adjuvant chemotherapy allowed only if with fluoropyrimidine monotherapy and more than 6 months elapsed between the end of adjuvant and first relapse.

  • Laboratory Requirements:

    • Neutrophils ≥1.5 x 109/L,
    • Platelets ≥100 x 109/L,
    • Hgb ≥ 9 g/dl.
    • Total bilirubin ≤ 1.5 time the upper-normal limits (UNL) of the normal values and ASAT (SGOT) and/or ALAT (SGPT) ≤ 2.5 x UNL (or <5 x UNL in case of liver metastases),
    • Alkaline phosphatase ≤ 2.5 x UNL (or <5 x UNL in case of liver metastases),
    • Creatinine clearance ≥ 50 mL/min or serum creatinine ≤1.5 x UNL,
    • Urine dipstick of proteinuria <2+. Pts discovered to have 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate <1 g of protein/24 hr.
  • Male subjects with female partners of childbearing potential must be willing to use adequate contraception as approved by the investigator (i.e. barrier contraceptive measure or oral contraception, total abstinence) during the study and until 6 months after the last treatment.
  • Geriatric assessment by means of G8 screening tool and CRASH score.
  • Written informed consent to study procedures and to molecular analyses before pts registration.
  • Will and ability to comply with the protocol.

Exclusion Criteria:

criteria

  • Previous adjuvant oxaliplatin-containing chemotherapy.
  • Previous treatment with bevacizumab.
  • Previous systemic treatment for the metastatic disease.
  • Previous radiotherapy treatment to any site within 4 weeks before the study.
  • Evidence of untreated brain metastases or spinal cord compression or primary brain tumours.
  • History or evidence upon physical examination of CNS disease unless adequately treated.
  • Symptomatic peripheral neuropathy > 1 grade NCIC-CTG criteria.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • Evidence of bleeding diathesis or coagulopathy.
  • Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy.
  • Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤6 months), myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), serious cardiac arrhythmia requiring medication.
  • Any previous venous thromboembolism > NCI CTCAE Grade 3.
  • History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.
  • Current ongoing treatment with anticoagulants for therapeutic purposes.
  • Chronic, daily treatment with high-dose aspirin (>325 mg/day).
  • Active uncontrolled infections or other clinically relevant concomitant illness contraindicating chemotherapy administration or putting the patient at high risk for treatment-related toxicities.
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ.
  • Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
  • Contraindications for the use of corticosteroids and antihistamines as premedication or known hypersensitivity to any other component of the study drugs.
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Up to 28 months
PFS is defined as the time from study enrollment to the first documentation of objective disease progression or death due to any cause, whichever occurs first.
Up to 28 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Oncologico Veneto IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COBRA

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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