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Neoadjuvant FOLFOXIRI Chemotherapy in Patients With Locally Advanced Colon Cancer

Primary Purpose

Colonic Neoplasms, Drug Therapy

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

FOLFOXIRI

About this trial

This is an interventional treatment trial for Colonic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Liaoning Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FOLFOXIRI

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tumor regression grade (TRG)

The level of tumor regression under pathological examination

Disease free survival

Estimated from the date of surgery to the date of recurrence

Overall survival time

Estimated from the date of enrollment to death from any cause

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

The grade of toxicity will be assessed using the NCI-CTCAE version 4.0

ctDNA change

The relationship between ctDNA and survival will be evaluated

SUVmax changes

Tumor metabolic response through FDG-PET examination before and after 4 cycles of neoadjuvant FOLFOXIRI chemotherapy

Quality of life (QLQ C30)

Scores according to EORTC QLQ-C30 scoring manual

Full Information

NCT ID

NCT03484195

First Posted

March 23, 2018

Last Updated

April 14, 2021

Sponsor

China Medical University, China

1. Study Identification

Unique Protocol Identification Number

NCT03484195

Brief Title

Neoadjuvant FOLFOXIRI Chemotherapy in Patients With Locally Advanced Colon Cancer

Official Title

Neoadjuvant FOLFOXIRI (Irinotecan, Oxaliplatin and Fluorouracil) Chemotherapy in Patients With Locally Advanced Colon Cancer：an Open-label, Single-arm, Multicenter Phase II Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2018 (Actual)

Primary Completion Date

October 1, 2021 (Anticipated)

Study Completion Date

October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

China Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colonic Neoplasms, Drug Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FOLFOXIRI

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

FOLFOXIRI

Other Intervention Name(s)

Irinotecan, Oxaliplatin, 5-Fluorouracil

Intervention Description

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)

Primary Outcome Measure Information:

Title

The ratio of tumor downstaging to stage 0 and stage I

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Tumor regression grade (TRG)

Description

The level of tumor regression under pathological examination

Time Frame

2 years

Title

Disease free survival

Description

Estimated from the date of surgery to the date of recurrence

Time Frame

3 years

Title

Overall survival time

Description

Estimated from the date of enrollment to death from any cause

Time Frame

3 years

Title

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Description

The grade of toxicity will be assessed using the NCI-CTCAE version 4.0

Time Frame

3 years

Title

ctDNA change

Description

The relationship between ctDNA and survival will be evaluated

Time Frame

3 years

Title

SUVmax changes

Description

Tumor metabolic response through FDG-PET examination before and after 4 cycles of neoadjuvant FOLFOXIRI chemotherapy

Time Frame

At the begin of Cycle 1 and the end of Cycle 4 (each cycle is 14 days)

Title

Quality of life (QLQ C30)

Description

Scores according to EORTC QLQ-C30 scoring manual

Time Frame

Every 2 weeks after the first treatment until 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jingdong Zhang

Phone

+86-13804027878

zhangjingdong@cancerhosp-ln-cmu.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jingdong Zhang

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

Liaoning Cancer Hospital

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuanhe Wang

wangyuanhe@sina.comm

First Name & Middle Initial & Last Name & Degree

Jingdong Zhang

12. IPD Sharing Statement

Learn more about this trial

Neoadjuvant FOLFOXIRI Chemotherapy in Patients With Locally Advanced Colon Cancer

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