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

JRCT ID: jRCTs061180022

Registered date:14/02/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 08/09/2015
• Target sample size: 360
• Study type: Interventional

Intervention(s)

A group;
FOLFOXIRI+ bevacizumab (To 12 courses), 5-FU+ Levofolinate+ bevacizumab (From 13 courses) given on day1 every 2weeks, until disease progression or unmanageable toxicity.
- Bevacizumab 5mg/kg/bi-weekly
- Irinotecan 150mg/m2/bi-weekly
- Oxaliplatin 85mg/m2/bi-weekly
- Levofolinate 200mg/m2/bi-weekly
- 5-FU 2400mg/m2/bi-weekly
B group;
FOLFOXIRI+ cetuximab (To 12 courses), 5-FU+ Levofolinate+ cetuximab (From 13 courses) given on day1 and day8 every 2weeks, until disease progression or unmanageable toxicity.
- Cetuximab (first time) 400 mg/m2/week
- Cetuximab (after 2nd time) 250 mg/m2/week
- Irinotecan 150mg/m2/bi-weekly
- Oxaliplatin 85mg/m2/bi-weekly
- Levofolinate 200mg/m2/bi-weekly
- 5-FU 2400mg/m2/bi-weekly

Outcome(s)

• Primary Outcome: Deepness of Response(DpR)
• Secondary Outcome: Early Tumor shrinkage(ETS), Response Rate(RR), Deepness of Response (at 4 weeks), Time to Treatment Failure(TTF), Time to Tumor Growth(TTG), Progression-Free Survival(PFS), Overall Survival(OS), Correlation between tumor shrinkage(ETS, RR, DpR) and prognosis(PFS, OS), Correlation between TTG and OS, Resection rate ,R0 resection rate, Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: TSUJI Akihito
• Source(s) of Monetary Support: Merck Biopharma Co.,Ltd
• Secondary ID(s): UMIN000018217