A randomized phase II study of FOLFOXIRI plus cetuximab versus FOLFOXIRI plus bevacizumab in metastatic colorectal cancer patients with RAS wild-type tumors

Phase 2

• Conditions: colorectal cancer

• Registration Number: JPRN-jRCTs061180022
• Lead Sponsor: TSUJI Akihito

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

(1) Histologically confirmed colorectal cancer.
(2) RAS wild-type.
(3) Measurable leision by RECIST.(Ver.1.1)
(4) No past history of chemotherapy in the case of unresectable primary lesion/distant metastasis/lymph node metastasis.In the case of recurrence, no treatment for the first recurrence leision after operation.
(5) Age; more than 20 years old.
(6) ECOG Performance status 0-1.The case >=71 years is PS0.

Exclusion Criteria

(1)Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. (2)Suspicious of Lynch syndrome
(3)Brain metastases.
(4)Infectious disease.
(5)Interstitial lung disease or pulmonary fibrosis.
(6)Comorbidity or history of serious heart failure.
(7)History of thromboembolic events.
(8)Cerebrovascular disease.
(9)History of hemoptysis/hematemesis.
(10)Uncontrolled hypertension.
(11)Sensory alteration or paresthesia interfering with function.
(12)Large quantity of pleural, abdominal or cardiac effusion.
(13)Severe comorbidity (renal failure, liver failure, hypertension, etc)
(14) Prior radiotherapy for primary and metastases leision.

Study & Design

• Study Type: Interventional
• Study Design: Not specified