Randomized Phase II Study of BSC vs Cetuximab vs Irinotecan and Cetuximab in Patients with KRAS codon G13D mutant Metastatic Colorectal Cancer (G13 study)

Randomized Phase II Study of BSC vs Cetuximab vs Irinotecan and Cetuximab in Patients with KRAS codon G13D mutant Metastatic Colorectal Cancer (G13 study) - G13 study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008850

Enrollment

Registered

2012-09-04

Start date

2012-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic colorectal cancer

Interventions

Cetuximab Cetuximab+Irinotecan BSC

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically confirmed colorectal cancer. (2) Metastatic colorectal cancer with EGFR. (3) KRAS codon G13D mutation. (4) Failed prior regimen containing irinotecan. (5) Age over 20 years. (6) ECOG Performance Status 0-2. (7) Measurable lesion based on RECIST ver1.1. (8) Adequate organ function for study treatment. (9) A life expectancy of more than 3 months. (10) Written informed consent.

Exclusion criteria

Exclusion criteria: (1) Severe myelosupression. (2) Severe infection. (3) Uncontrolled diarrhea. (4) Pleural effusion, ascites and pericardial fluid. (5) Serious heart disease. (6) Intestinal lung disease or pulmonary fibrosis. (7) Bowel obstruction. (8) Jaundice. (9) Receiving Atazanavir Sulfate. (10) History of severe allergy. (11) Allergy for irinotecan. (12) Pregnant or possibly pregnant, and nursing women. (13) Severe comorbidity(renal failure, hepatic failure, hypertension, hypercalcemia) (14) Symptomatic brain metastases. (15) multiple malignancies. (16) Other conditions not suitable for this study.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	—

Secondary

Measure	Time frame
Overall Response Rate, Response Rate by metastatic site, Disease Control Rate, Overall Survival, Safety.	—

Countries

Japan

Contacts

Public ContactYumi Miyashita

Epidemiological and Clinical research Information Network (ECRIN) Aichi branch

miya@ecrin.or.jp052-744-2442

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026