Status:
UNKNOWN
Neoadjuvant FOLFOXIRI Chemotherapy in Patients With Locally Advanced Colon Cancer
Lead Sponsor:
China Medical University, China
Conditions:
Colonic Neoplasms
Drug Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) in the patients with locally advanced colon cancer.
Detailed Description
For the patients with locally advanced colon cancer, adjuvant FOLFOX and XELOX chemotherapy have become standard treatment. However, 30% - 40% patients suffered from local recurrence or distant metast...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age: 18-75years old
- Primary and pathological diagnosis of colon adenocarcinoma
- Radiographic evaluation of initial resectable colon cancer
- T4b colon cancer
- ECOG status: 0～1
- Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
- Neutrophil count≥1.5×10\^9/L Platelet count≥90×10\^9/L Hemoglobin≥90g/L Total bilirubin (TBI) ≤ 1.5 \* ULN Alanine aminotransferase (ALT)≤2.5 \* ULN Aspartate aminotransferase (AST)≤2.5 \* ULN Alkaline phosphatase (ALP)≤2.5 \* ULN
- Signed informed consent; able to comply with study and/or follow- up procedures
- Exclusion Criteria:
- Previous treatment with oxaliplatin, irinotecan or fluorouracil
- Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.
- With distant metastasis
- Cardiovascular disease that would preclude study treatment or follow-up; New York Heart Association class III or IV heart disease; active ischemic heart disease; myocardial infarction within the past 6 months; symptomatic arrhythmia uncontrolled hypertension. Unexplained syncope occurred within 3 months
- Digestive system diseases that would preclude study treatment or follow-up within the past 6 months
- Gastric ulcers or duodenal ulcers for the treatment of resistance;
- 3 or 4 grade gastrointestinal bleeding / bleeding;
- Gastrointestinal perforation / fistula;
- abdominal abscess;
- Infectious or inflammatory bowel disease
- HIV infection and/or active hepatitis B virus infection
- Pregnant or lactating women. Fertile patients must use effective contraception
- Any serious acute or chronic disease that can not be involved in the study or to influence the interpretation of the results of the study
- Other intervention clinical trials were combined at the same time.
- Nerve or mental abnormality affecting cognitive ability
- Other malignancy except effectively treated squamous cell or basal cell skin cancer,
- Other situations that the researchers think should be excluded
Exclusion
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03484195
Start Date
April 1 2018
End Date
October 1 2021
Last Update
April 19 2021
Active Locations (1)
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1
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110000