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A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC

ConditionsColorectal NeoplasmsNeoplasm MetastasisIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System Neoplasms
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

The primary purpose of this study is to determine the non-inferiority of overall survival FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer.

Age ≥18 years at the time of informed consent

ECOG performance status (PS) of 0-2

Written informed consent prior to study-specific screening procedures

Disqualifiers

History of other malignancy with a disease-free interval <5 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection)

With massive pleural effusion or ascites requiring intervention

Radiological evidence of brain tumor or brain metastases

Active infection including hepatitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bevacizumab

    Biological/Vaccine

    5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle.

  • CPT-11

    Drug

    180 mg/m2 intravenously administered over 90 minutes on day 1 of a 2-week cycle

  • 5-FU Bolus

    Drug

    400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.

  • 5-FU Infusion

    Drug

    2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.

  • l-LV (dl-LV)

    Drug

    200 (dl-LV: 400) mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: FOLFIRI +/- BevacizumabExperimental treatment 5 interventions
Group B: CPT-11 +/- BevacizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

Time from the date of enrollment to the earlier of the date of confirmed progression or death from any cause.

Time frame
Assessed until 1.5 years after the last patient enrolment

Secondary outcomes

1

Overall survival

Time from the date of enrollment to death from any cause

Time frame
Assessed until 1.5 years after the last patient enrolment
2

Time to treatment failure (TTF)

Time from the date of enrollment to the earlier of the date of confirmed progression, death from any cause, or discontinuation of protocol treatment.

Time frame
Assessed until 1.5 years after the last patient enrolment
3

Overall Response Rate (ORR)

Proportion of eligible patients with measurable lesions with a best overall response of CR or PR assessed by the attending physician.

Time frame
Assessed at 6, 12 week and thereafter every 8 weeks, from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks
4

Disease Control Rate (DCR)

Proportion of best overall response of CR, PR, or SD assessed by the attending physician.

Time frame
Assessed at 6, 12 week and thereafter every 8 weeks, from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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