Neoadjuvant FOLFOXIRI Chemotherapy in Patients With Locally Advanced Colon Cancer

China Medical University, China

Status and phase

Unknown

Phase 2

Conditions

Drug Therapy

Colonic Neoplasms

Treatments

Drug: FOLFOXIRI

Study type

Interventional

Funder types

Other

Identifiers

NCT03484195

LGIOG-2017-01

Details and patient eligibility

About

To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) in the patients with locally advanced colon cancer.

Full 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 metastasis after this standard treatment. Neoadjuvant chemotherapy could shrink tumors, eliminate micrometastasis, reduce surgical trauma and accelerate recovery. Hence, we evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy in treating patients with locally advanced colon cancer.

In this prospective study, 30 patients with locally advanced colon cancer will be treated with 4 cycles of neoadjuvant FOLFOXIRI chemotherapy followed by surgical resection. PET-CT scanning will be performed before and after the neoadjuvant FOLFOXIRI chemotherapy to assess SUVmax changes. The ctDNA in peripheral blood before and after each cycle of neoadjuvant FOLFOXIRI chemotherapy will be detected. In the course of treatment, safety evaluation will be carried out according to adverse reaction classification (CTCAE) 4. 0.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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