Neoadjuvant FOLFOXIRI Chemotherapy in Patients With Locally Advanced Colon Cancer

NCT ID: NCT03484195

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2021-10-01

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 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.

Conditions

Colonic Neoplasms; Drug Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FOLFOXIRI

Patients received 4 cycles of neoadjuvant FOLFOXIRI chemotherapy before surgical resection.

Group Type: EXPERIMENTAL

FOLFOXIRI

Intervention Type: DRUG

Irinotecan 150 mg/m\^2 IV over 1h, day 1 + Oxaliplatin 85 mg/m\^2 IV over 2h, day 1 + L-Leucovorin 200 mg/m\^2 IV over 2h, day 1 + 5-Fluorouracil 2800 mg/m\^2 IV 48h continuous infusion, starting on day 1 administered every two weeks for 4 cycles (2 months)

Interventions

FOLFOXIRI

Irinotecan 150 mg/m\^2 IV over 1h, day 1 + Oxaliplatin 85 mg/m\^2 IV over 2h, day 1 + L-Leucovorin 200 mg/m\^2 IV over 2h, day 1 + 5-Fluorouracil 2800 mg/m\^2 IV 48h continuous infusion, starting on day 1 administered every two weeks for 4 cycles (2 months)

Intervention Type: DRUG

Other Intervention Names

Irinotecan; Oxaliplatin; 5-Fluorouracil

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Jingdong Zhang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jingdong Zhang

Role: STUDY_CHAIR

Cancer Hospital of China Medical University, Department of Medical Oncology, Liaoning Cancer Hospital & Institute

Locations

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jingdong Zhang

Role: CONTACT

zhangjingdong@cancerhosp-ln-cmu.com

+86-13804027878

Facility Contacts

Yuanhe Wang

Role: primary

wangyuanhe@sina.comm

Other Identifiers

LGIOG-2017-01

Identifier Type: -

Identifier Source: org_study_id