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WithdrawnNCT02542436Updated Sep 13, 2017

Avastin (Bevacizumab) in the Treatment of Metastatic Colorectal Cancer in Normal Clinical Use in the UK Population

An observational study in Metastatic Colorectal Cancer, sponsored by Hoffmann-La Roche. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-13.

Sponsored by Hoffmann-La Roche · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

This study will focus on participants in the United Kingdom (UK) to collect local data on the effectiveness and safety of bevacizumab (Avastin) in the treatment of metastatic colorectal cancer in normal clinical use.

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Conditions studied

  • Metastatic Colorectal Cancer
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

Browse Colorectal Neoplasms studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants with metastatic colorectal cancer

Inclusion criteria

  • Have been diagnosed with metastatic colorectal cancer (mCRC)
  • Have a Performance Status (PS) of 0-2, according to the Eastern Cooperative Oncology Group (ECOG) criteria at initiation of bevacizumab treatment
  • Be chemotherapy-naive at diagnosis of mCRC or have relapsed more than 12 months after receiving adjuvant chemotherapy for early stage colorectal cancer
  • Have received standard fluoropyrimidine-based chemotherapy for first-line treatment of mCRC with or without bevacizumab
  • Have sufficient medical records available for assessment of eligibility at the Christie Hospital National Health Service (NHS) Trust, Manchester, United Kingdom
  • For Cohort 1 (post CDF funding availability): patients between 2010-2013 who received bevacizumab with first-line chemotherapy
  • For Cohort 2 (pre Cancer Drugs Fund [CDF] funding availability): patients propensity matched to cohort 1 between 2005-2008 who did not receive bevacizumab with first-line chemotherapy

Exclusion criteria

Exclusion Criteria:

  • Subjects with metastatic colorectal cancer, who have received bevacizumab via a clinical trial
  • Subjects with metastatic colorectal cancer, whose medical records are not complete enough to confirm eligibility for the study
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Cohort 1: bevacizumab

    Participants with metastatic colorectal cancer between 2010-2013, who received bevacizumab (25 mg/ml concentrate for solution for infusion) with first-line chemotherapy.

    Other: No intervention

  • Cohort 2: no bevacizumab

    Participants with metastatic colorectal cancer between 2005-2008, who did not receive bevacizumab with first-line chemotherapy.

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention administered in this study

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What researchers measure

Primary outcomes

  1. Overall Survival (OS)

    Time frame: From date of metastatic colorectal cancer diagnosis to date of death up to 3 years

Secondary outcomes

  1. Response Rate (RR)

    Time frame: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years

  2. Progression Free Survival (PFS)

    Time frame: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years

  3. Percentage of Participants with Adverse Events of Special Interest

    Time frame: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years

07

Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02542436
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Sep 7, 2015
Start date
Sep 1, 2015 (estimated)
Primary completion
Dec 31, 2015 (estimated)
Completion
Dec 31, 2015 (estimated)
Last update
Sep 13, 2017

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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