Elderly Metastatic Colorectal Cancer PatientsCOBRANCT03451370
First-line Combination of Capecitabine and Oxaliplatin Plus Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer
An observational study of Elderly Metastatic Colorectal Cancer Patients, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Elderly Metastatic Colorectal Cancer Patients
- What is being tested?
- Capecitabine, Oxaliplatin and Bevacizumab
- Type of treatment
- Injection or infusion
- How many people
- 121 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2017to Apr 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly (> 70 years) patients with metastatic colorectal cancer
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
- Being tested
- Capecitabine, Oxaliplatin, Bevacizumab
- Keywords
- Bevacizumab, Capecitabine, Oxaliplatin, CRASH score, ECOG PS, G8 score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
750 mg/sqm/bid, day 2 to 15; if toxicities grade ≥2 do not occur, pts may subsequently receive capecitabine 1000 mg/sqm/bid, day 2 to 15 starting the second cycle based on investigator's choice.
To be repeated every 3 weeks (21 days), for a maximum of 8 cycles.
If no progression occurs, pts will receive maintenance capecitabine (starting at the same dose used at the last cycle of the induction treatment) plus bevacizumab every 3 weeks (21 days), until disease progression, unacceptable toxicity or patient's refusal.
OxaliplatinDrug
100 mg/sqm iv over 2 hours, day 1 To be repeated every 3 weeks (21 days), for a maximum of 8 cycles.
BevacizumabDrug
7.5 mg/kg iv over 90 minutes, day 1; if the first infusion is tolerated, then subsequent infusions may be administered in 30 minutes.
If no progression occurs, pts will receive maintenance capecitabine (starting at the same dose used at the last cycle of the induction treatment) plus bevacizumab every 3 weeks (21 days), until disease progression, unacceptable toxicity or patient's refusal. To be repeated every 3 weeks (21 days), for a maximum of 8 cycles.
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
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.
Measured: Up to 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Nov 2017
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly Metastatic Colorectal Cancer PatientsStudies 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
- 121 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451370
- Sponsor's protocol ID
- COBRA
- Acronym
- COBRA
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2018
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-line Combination of Capecitabine and Oxaliplatin + Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03451370
- Acronym / sponsor ID
- COBRA / COBRA
- Keywords
- Bevacizumab, Capecitabine, Oxaliplatin, CRASH score, ECOG PS, G8 score
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 1 Mar 2018 (actual)
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly (> 70 years) patients with metastatic colorectal cancer
Key inclusion criteria (21 listed)
- 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).
Key exclusion criteria (22 listed)
- 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.
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 |
|---|---|---|
| Capecitabine750 mg/sqm/bid, day 2 to 15; if toxicities grade ≥2 do not occur, pts may subsequently receive capecitabine 1000 mg/sqm/bid, day 2 to 15 starting the second cycle based on investigator's choice. To be repeated every 3 weeks (21 days), for a maximum of 8 cycles. If no progression occurs, pts will receive maintenance capecitabine (starting at the same dose used at the last cycle of the induction treatment) plus bevacizumab every 3 weeks (21 days), until disease progression, unacceptable toxicity or patient's refusal. | Drug | – |
| Oxaliplatin100 mg/sqm iv over 2 hours, day 1 To be repeated every 3 weeks (21 days), for a maximum of 8 cycles. | Drug | – |
| Bevacizumab7.5 mg/kg iv over 90 minutes, day 1; if the first infusion is tolerated, then subsequent infusions may be administered in 30 minutes. If no progression occurs, pts will receive maintenance capecitabine (starting at the same dose used at the last cycle of the induction treatment) plus bevacizumab every 3 weeks (21 days), until disease progression, unacceptable toxicity or patient's refusal. To be repeated every 3 weeks (21 days), for a maximum of 8 cycles. | Drug | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Elderly Metastatic Colorectal Cancer Patients, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
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 21 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Progression Free Survival (PFS) (time frame: Up to 28 months). 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 15 Apr 2026.