Prospectively Randomized Control Clinical Trial of neoadjuvant modified FOLOXIRI chemotherapy alone compared to neoadjuvant modified FOLFOX6 chemotherapy for locally advanced colon cancer in cT4b

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000032387

Enrollment

Unknown

Registered

2020-04-27

Start date

2020-05-01

Completion date

Unknown

Last updated

2020-04-27

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

Conditions

colon cancer

Interventions

experimental group:neoadjuvant modified FOLOXIRI chemotherapy alone

control group:neoadjuvant modified FOLFOX6 chemotherapy alone

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 to 70 years at diagnosis; 2. Diagnosis of colon adenocarcinoma (T Stage: T4b according to radiology); 3. Distal border of the tumor must be located >12 cm from the anal verge; 4. ECOG status 0 or 1; 5. Without any anticancer treatment before inclusion; 6. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment; 7. Signed informed consent; able to comply with study and/or follow- up procedures.

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to fluorouracil, oxaliplatin or irinotecan; 2. With serious basic diseases: heart disease, kidney failure, severe liver dysfunction or liver failure, coagulation dysfunction or oral dose of anticoagulant drugs; 3. Patient had second malignant disease within 5 years; 4. Multiple primary colon cancer patients,or have been systematic chemotherapy; 5. With clinical symptoms requiring emergency surgery for treatment (complete obstruction, bleeding, intestinal perforation); 6. Had metastatic disease; 7. Included in other clinical trails; 8. Pregnant and Nursing women.

Design outcomes

Primary

Measure	Time frame
R0 resection rate;	—

Secondary

Measure	Time frame
objective response rate;tumor regression grade;The incidence of >=3 grade adverse events;pathologic complete response rate;postoperative complications;rate of local recurrence;disease-free survival (Time Frame: 3 years);Overall survival (Time Frame: Three years);disease-free survival (Time Frame: 5 years);Overall survival (Time Frame: 5 years);Distant metastasis rate;	—

Countries

China

Contacts

Public ContactQiang Li

Third Affiliated Hospital, Kunming Medical University

1390811139@qq.com+86 13888387868

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026