An exploratory study to evaluate molecular predictive and/or prognostic factors of benefit from a randomized, phase III trial of sequential capecitabine/5FU plus bevacizumab (Cape/5FU-Bmab) to capecitabine/5FU plus oxaliplatin plus bevacizumab (CapeOX/mFOLOFX6-Bmab) versus combination CapeOX/mFOLFOX6-Bmab in advanced colorectal cancer.

An exploratory study to evaluate molecular predictive and/or prognostic factors of benefit from a randomized, phase III trial of sequential capecitabine/5FU plus bevacizumab (Cape/5FU-Bmab) to capecitabine/5FU plus oxaliplatin plus bevacizumab (CapeOX/mFOLOFX6-Bmab) versus combination CapeOX/mFOLFOX6-Bmab in advanced colorectal cancer. - C-Prime Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016165

Enrollment

304

Registered

2015-01-09

Start date

2015-01-10

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

Unresectable advanced colorectal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Participating the C-Cubed study with written informed consent. 2) Written informed consent after receiving explanation of planned treatments in the study.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Correlation between image evaluation/clinical data and molecular predictive and/or prognostic factors including genetic and epigenetic alterations derived from colorectal cancer tissues	—

Secondary

Measure	Time frame
1) Correlation between prognostic factors including genetic and epigenetic alterations derived from colorectal cancer tissues and the evaluation criteria about efficacy/safety; ORR (Overall response rate), PFS (Progression free-survival), DDC (Duration of disease control), TTF (Time to treatment-failure), OS (Overall survival), Safety, and QoL (Quality of Life), 2) Relevance between evaluations of the C-Cubed study and molecular predictive and/or prognostic factors including genetic and epigenetic alterations derived from colorectal cancer tissues. 3) Relevance between each molecular predictive and/or prognostic factors including genetic and epigenetic alterations derived from colorectal cancer tissues.	—

Measure

Time frame

1) Correlation between prognostic factors including genetic and epigenetic alterations derived from colorectal cancer tissues and the evaluation criteria about efficacy/safety; ORR (Overall response rate), PFS (Progression free-survival), DDC (Duration of disease control), TTF (Time to treatment-failure), OS (Overall survival), Safety, and QoL (Quality of Life), 2) Relevance between evaluations of the C-Cubed study and molecular predictive and/or prognostic factors including genetic and epigenetic alterations derived from colorectal cancer tissues. 3) Relevance between each molecular predictive and/or prognostic factors including genetic and epigenetic alterations derived from colorectal cancer tissues.

—

Countries

Japan

Contacts

Public ContactTakeshi Nagasaka

Kawasaki Medical School Department of Gastroenterological Surgery

takeshin@med.kawasaki-m.ac.jp086-462-1111

Outcome results