A phase II study of 2nd-line FOLFIRI+aflibercept in patients with colorectal cancer resistant to anti-EGFR chemotherapy (HGCSG1801)

JRCT ID: jRCTs011190006

Registered date:19/11/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 23/01/2020
• Target sample size: 41
• Study type: Interventional
• Intervention(s): FOLFIRI+aflibercept therapy is administered.

Outcome(s)

• Primary Outcome: progression-free survival rate at six months (PFS rate at 6 months)
• Secondary Outcome: overall survival, progression-free survival, response rate, disease control rate, adverse events and relative dose intensity for each drug

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1. Age 20-85 years old
2. Histologically confirmed colorectal adenocarcinoma
3. ECOG PS 0 or 1
4. Documented disease progression 90days or more after the start of 1st-line chemotherapy containing anti-EGFR antibodies, oxaliplatin and fluoropyrimidines.
5. Adequate major organ and hematological functions within 14days before registration
6. Expected survival time 3 months or more at the registration
7. With documented informed consent

Exclude criteria

1. Symptomatic CNS invasion and/or brain metastases
2. Uncontrollable infections
3. Uncontrollable diarrhea, anorexia or nausea
4. Uncontrollable hypertension
5. Symptomatic plural effusion or ascites
6. Inability of oral intake
7. Radiation to all lesions
8. UGT1A1 *6 homo, *28 homo, or *6 and *28 double hetero
9. History of other malignancies within 5 years (except for curative resection of carcinoma in situ)
10. Pregrant women
11. Irinotecan-containing regimen as 1st-line therapy
12. Following status:
Gastrointestinal or abdominal inflammations
Gastrointestinal or other bleeding
Hemorrhagic diathesis, coagulopathy, or treated with anticoagulants
Thromboembolism
No wound healing from major surgery
13. Administration of aflibercept-containing medications
14. Dihydropyrimidine dehydrogenase deficiency
15. Interstitial pneumonia or pulmonary fibrosis
16. Participation in the clinical trial is determined as unsuitable

Related Information

• Primary Sponsor: Komatsu Yoshito
• Secondary Sponsor: Hokkaido Gastrointestinal Cancer Study Group