The follow up study of "Phase l / ll Study of S-1+oxaliplatin (SOX)+cetuximab as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type (JACCRO CC-06)".

The follow up study of "Phase l / ll Study of S-1+oxaliplatin (SOX)+cetuximab as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type (JACCRO CC-06)". - JACCRO CC-06 B

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000027014

Enrollment

Registered

2017-04-18

Start date

2017-04-10

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with histologically proven colorectal cancer. (2) Metastatic colorectal cancer with EGFR expressed. (3) KRAS wild type in codon 12, 13. (4) Presence of measurable lesion (RECIST Ver.1.) . (5) No prior chemotherapy for unresectable primary tumor, metastases and lymph node metastasis. No primar therapy including surgery for recurrent that should be the first relapse after surgery for primary or metastases tumors. (6) ECOG Performance Status (PS) 0-1. (7) Age over 20 years. (8) Life expectancy of more than 3 months. (9) Oral food intake possible. (10) Patients have enough organ function for study treatment. (11) Written informed consent.

Exclusion criteria

Exclusion criteria: (1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. (2) Symptomatic brain metastases. (3) Severe infectious disease. (4) Interstitial lung disease or pulmonary fibrosis. (5) Comorbidity or history of heart failure. (6) Sensory alteration or paresthesia interfering with function. (7) Large quantity of pleural, abdominal or cardiac effusion. (8) Severe comorbidity (renal failure, liver failure, hypertension, etc). (9) Prior radiotherapy for primary and metastases tumors. (10) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test. (11) History of severe allergy. (12) History of allergy for L-OHP and other platinating agent. (13) Prior treatment of cetuximab or L-OHP or TS-1. (14) Administration of flucytosine. (15) Any other cases who are regarded as inadequate for study enrollment by investigators.

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS)	—

Countries

Japan

Contacts

Public ContactMasashi Fujii

Japan Clinical Cancer Research Organization Office

cc06.dc@jaccro.or.jp03-5579-9882

Outcome results