Neoadjuvant FOLFOXIRI Chemotherapy in Resectable Liver Metastasis of Colorectal Cancer

NCT03487939 | Unknown Phase 2

• 1 other identifier: LGIOG-2017-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) in the patients with resectable liver metastasis of colorectal cancer

Conditions

Colorectal Neoplasms; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• The ratio of tumor downstaging to stage 0 and stage I

  Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I

  2 years

Secondary Outcomes (7)

• Tumor regression grade (TRG)

  2 years

• Disease free survival

  3 years

• Overall survival time

  3 years

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  3 years

• ctDNA assessment and relation to clinical outcome

  3 years

Study Arms (1)

FOLFOXIRI

EXPERIMENTAL

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

Drug: FOLFOXIRI

Interventions

FOLFOXIRI DRUG

IRINOTECAN 150 mg/m\^2 IV over 1-h, day 1 + OXALIPLATIN 85 mg/m\^2 IV over 2-h, day 1 + L-LEUCOVORIN 200 mg/m\^2 IV over 2-h, day 1 + 5-FLUOROURACIL 2800 mg/m\^2 IV 48-h continuous infusion, starting on day 1 administered every two weeks for 4 cycles (2 months).

Also known as: Irinotecan, Oxaliplatin, 5-Fluorouracil

FOLFOXIRI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75years old
• Histologically confirmed colorectal cancer with liver metastasis (all patients should have the pathological report of colorectal cancer). The chances of hepatocellular carcinoma or metastasis from other primary lesions should be excluded.
• It was confirmed by imaging that the liver metastases and the primary intestinal lesions were all resectable.
• Radical resection of colorectal cancer after adjuvant chemotherapy complete 1 years later with liver metastases.
• There is at least one measurable objective tumor of the tumor (according to the 1.1 version of RECIST standard).
• Liver metastases can be excised by R0 and sufficient normal liver tissue can be retained
• 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

You may not qualify if:

• Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.
• In addition to liver metastases, there are other parts of 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
• Gastric ulcers or duodenal ulcers for the treatment of resistance;
• 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.

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

Liaoning cancer hospital

Shenyang, Liaoning, 110000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

FOLFOXIRI protocol; Irinotecan; Oxaliplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Yuanhe Wang, Doctor

CONTACT

18900918737; wangyuanhe@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 24, 2018
• First Posted: April 4, 2018
• Study Start: May 1, 2018
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

CN (1)