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The feasibility and efficacy of neoadjuvant FOLFOXIRI followed by laparoscopic surgery for locally advaned rectal cancer: A phase II study

The feasibility and efficacy of neoadjuvant FOLFOXIRI followed by laparoscopic surgery for locally advaned rectal cancer: A phase II study - nacFOLFOXIRI followed by LAP(NFL)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026575
Enrollment
58
Registered
2017-03-16
Start date
2017-03-17
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

colorectal cancer

Interventions

chemotherapy : FOLFOXIRI

Sponsors

Osaka Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically confirmed CRC that is not a candidate for curative surginal resection 2)the lower edge of tumor location is Rb-P 3)diagnosed as cT2N1-3N0 or cT3/4N0-3M0 4)there is no lateral lympha node metastasis 5)Age 20-74 6)Psrformance status:0-1 7)Adequate organ functiont 8)Written informed consent prior to sutudy-specific screening procedure

Exclusion criteria

Exclusion criteria: 1)Requires continuous treatment with systtematic steroids 2)History of other malignancy with a disease-free interval<1years(other than curatively treated cutaneous basal cell carcinoma,curatively treated carcinoma in situ of the cervix,and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection) 3)Active infections Pr evious palliative radiation therapy for bone metastasis or brain metastasis within 2 weeks 4)HBs antigen positive 5)Uncontrolled diarrhea,unstable angia,Uncontrolled diabetes mellitus 6)Serious complications 7)grade1 of neuropathy 8)Pregnant or lactating females,and males and fenales unwilling to use contraception 9)Psychiatric disability that would preclude study compliance 10)Otherwise determined by the investigator to be unsuitable for participation in the study

Design outcomes

Primary

MeasureTime frame
Disease control rate: DCR

Secondary

MeasureTime frame
Response Rate:RR,Progression free survival:PFS,Overall survival:OS,Time to Treatment Failure:TTF,Safety(the rate of Grade3/4toxicity)

Countries

Japan

Contacts

Public ContactTetsuji Terasawa

Osaka Medical College Hospital Chemotherapy Center

terasawat@osaka-med.ac.jp072-683-1211

Outcome results

None listed

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