PhaseII trial of neoadjuvant chemotherapy for recurrent colorectal cancer with resectable extra hepatic metastases

PhaseII trial of neoadjuvant chemotherapy for recurrent colorectal cancer with resectable extra hepatic metastases - N-SOG 07

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006783

Enrollment

Registered

2011-11-28

Start date

2011-10-01

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

recurrent colorectal cancer with resectable extra hepatic metastases

Interventions

Neoadjuvant chemotherapy with FOLFOX plus panitumumab followed by surgery Neoadjuvant chemotherapy with FOLFIRI plus panitumumab followed by surgery Neoadjuvant chemotherapy with FOLFOX plus bevacizum

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed adenocarcinoma of colorectal cancer 2) Chemotherapy un-treating and having existing treated do not ask. 3) Analysis result of KRAS gene becomes clear by 2 course start 4) Recurrent colorectal cancer with resectable extra hepatic metastases 5) Already resected, or resectable 6)Without prior surgery,chemotherapy, radiotherapy and radiofrequency ablation for the target metastases 7)Performance status(PS) 0-1 8)Age:20-80 years 9)Alife expectancy greater than 12 weeks 10)Adequate organ function within 14 days before chemotherapy 11) Written informed consent

Exclusion criteria

Exclusion criteria: 1)History of drug hypersensitivity 2)Dysesthesia 3) Contraindications to using drugs 4)Multiple malignacies to be treated 5)Have hematopoietic drugs within 7days before enrollment 6)Uncontrolled body cavity fluid 7)Serious infection 8)With brain metastases 9)Significant abnormal ECG or history of cardiovascular disease 10)Serious lung disease 11)With hemorrhage 12)Uncontrolled diarrhea 13)With Intestinal paralysis, or obstruction 14)History of central nervous system disorder 15) With dementia,or severe mental disorder 16) Gravida or lactating woman 17)Not suitable for participation with any other reasons

Design outcomes

Primary

Measure	Time frame
treatment completion rate	—

Secondary

Measure	Time frame
R0 resection rate, pCR rate, adverse event, response rate, recurrence free survival, 3-year disease free survival, overall survival	—

Countries

Japan

Contacts

Public ContactKeisuke Uehara

Nagoya University Graduated School of Medicine Division of Surgical Oncology

kuehara@med.nagoya-u.ac.jp052-744-2222

Outcome results

None listed

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