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A Trial of Neoadjuvant mFOLFOXIRI Versus CRT in the EMVI Positive LARC

Primary Purpose

Locally Advanced Rectal Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

mFOLFOXIRI

Chemoradiotherapy

About this trial

This is an interventional treatment trial for Locally Advanced Rectal Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged ≥ 18 to 70 years at diagnosis;
ECOG status 0-2;
Diagnosis of rectal adenocarcinoma(Distal border of the tumor must be located < 12 cm from the anal verge);
MRI examination diagnosed EMVI-positive;
Tumor amenable to curative resection;
Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: (1) Neutrophilic granulocytes ≥ 3.0 x10^9/L, Platelet count ≥ 75 x 10^9/L, Hemoglobin (Hb) ≥ 90g/L; (2) bilirubin ≤1.5 x the upper limit of normal (ULN),Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 2.5 x ULN; (3) Serum creatinine ≤ 1.5 x ULN.No renal disease that would preclude study treatment or follow-up
Signed informed consent; able to comply with study and/or follow- up procedures

Exclusion Criteria:

Hypersensitivity to fluorouracil, oxaliplatin or irinotecan;
Patient had received pelvic radiotherapy;
Patient had received systemic chemotherapy;
History of invasive colon or rectal malignancy, regardless of disease-free interval;
Had metastatic disease;
Patient had second malignant disease within 5 years;
Uncontrolled co-morbid illnesses or other concurrent disease;
Patients refused to signed informed consent.
Pregnant and Nursing women

Sites / Locations

The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

mFOLFOXIRI

Chemoradiotherapy(CRT)

Arm Description

Patients receive 6 cycles of mFOLFOXIRI

Patients receive standard chemoradiotherapy

Outcomes

Primary Outcome Measures

MFS

metastasis free survival

Secondary Outcome Measures

Tumor downstaging rate

the proportion of tumor downstaging to ypT0-2N0M0

pCR

Pathologic complete response rate

RFS

recurrence-free survival

DFS

disease-free survival

overall survival

Reported Adverse events

The incidence of >=3 grade adverse events

Full Information

NCT ID

NCT04423965

First Posted

June 8, 2020

Last Updated

March 21, 2021

Sponsor

First Affiliated Hospital of Zhejiang University

Collaborators

First Affiliated Hospital of Wenzhou Medical University, Zhejiang Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04423965

Brief Title

A Trial of Neoadjuvant mFOLFOXIRI Versus CRT in the EMVI Positive LARC

Official Title

A Multicenter Randomized Controlled Phase II Trial of Neoadjuvant mFOLFOXIRI Versus Routine Chemoradiotherapy in the EMVI Positive Locally Advanced Rectal Cancer (TRICHEMO)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Recruiting

Study Start Date

May 12, 2020 (Actual)

Primary Completion Date

May 1, 2022 (Anticipated)

Study Completion Date

May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital of Zhejiang University

Collaborators

First Affiliated Hospital of Wenzhou Medical University, Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

Extramural Vascular Invasion Positive(EMVI+) is a high risk of distant metastasis for locally advanced rectal cancer(LARC) after resection. The study is to evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC in contrast to the efficacy of standard Chemoradiotherapy (CRT).

Detailed Description

It is an investigator-initiated, multicentered, randomized controlled clinical study to evaluate the efficacy and safety of mFOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC in contrast to standard chemoradiotherapy. Patients of LARC with EMVI+ evaluated by pelvic magnetic resonance imaging (MRI) are enrolled in this trial. All patients will be randomized divided into two groups. Experimental group will receive 3 cycles of mFOLFOXIRI, followed to be performed MRI to assess clinical response. If the tumor response is good enough (partial response or complete response), the patient will receive another 3 cycles of mFOLFOXIRI then surgery. On the contrary, if the tumor shows poor response (stable disease or progressive disease) or with mesorectal fascia-positive or ycT4a/b after re-evaluation, radiotherapy will be performed combined with capecitabine before operation. Control group will receive standard capecitabine based chemoradiotherapy. Patients with mesorectal fascia-positive or ycT4a/b after re-evaluation would receive radiation before surgery, whereas responders would have immediate total mesorectal excision (TME). All patients will receive 4 cycles of XELOX as adjuvant chemotherapy after TME.

6. Conditions and Keywords

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

Locally Advanced Rectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mFOLFOXIRI

Arm Type

Experimental

Arm Description

Patients receive 6 cycles of mFOLFOXIRI

Arm Title

Chemoradiotherapy(CRT)

Arm Type

Experimental

Arm Description

Patients receive standard chemoradiotherapy

Intervention Type

Drug

Intervention Name(s)

mFOLFOXIRI

Intervention Description

irinotecan 165 mg/m² IV day 1+ oxaliplatin 85 mg/m² IV day 1 + leucovorin 400 mg/m² day 1, fluorouracil 1200mg/m²/day *2 days (total 2400 mg/m² over 48 hours) continuous infusion starting on day 1 of each 2 weeks cycle

Intervention Type

Combination Product

Intervention Name(s)

Chemoradiotherapy

Intervention Description

Capecitabine based chemoradiotherapy

Primary Outcome Measure Information:

Title

MFS

Description

metastasis free survival

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Tumor downstaging rate

Description

the proportion of tumor downstaging to ypT0-2N0M0

Time Frame

2 years

Title

pCR

Description

Pathologic complete response rate

Time Frame

2 years

Title

RFS

Description

recurrence-free survival

Time Frame

3 years

Title

DFS

Description

disease-free survival

Time Frame

3 years

Title

Description

overall survival

Time Frame

5 years

Title

Reported Adverse events

Description

The incidence of >=3 grade adverse events

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged ≥ 18 to 70 years at diagnosis; ECOG status 0-2; Diagnosis of rectal adenocarcinoma(Distal border of the tumor must be located < 12 cm from the anal verge); MRI examination diagnosed EMVI-positive; Tumor amenable to curative resection; Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: (1) Neutrophilic granulocytes ≥ 3.0 x10^9/L, Platelet count ≥ 75 x 10^9/L, Hemoglobin (Hb) ≥ 90g/L; (2) bilirubin ≤1.5 x the upper limit of normal (ULN),Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 2.5 x ULN; (3) Serum creatinine ≤ 1.5 x ULN.No renal disease that would preclude study treatment or follow-up Signed informed consent; able to comply with study and/or follow- up procedures Exclusion Criteria: Hypersensitivity to fluorouracil, oxaliplatin or irinotecan; Patient had received pelvic radiotherapy; Patient had received systemic chemotherapy; History of invasive colon or rectal malignancy, regardless of disease-free interval; Had metastatic disease; Patient had second malignant disease within 5 years; Uncontrolled co-morbid illnesses or other concurrent disease; Patients refused to signed informed consent. Pregnant and Nursing women

Central Contact Person:

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

Guosheng Wu, MD

Phone

+8617857310313

Ext

87236858

guosheng_wu@zju.edu.cn

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

Weiqin Jiang, MD

Phone

+8615068117618

Ext

87236858

1312028@zju.edu.cn

Facility Information:

Facility Name

The First Affiliated Hospital, Zhejiang University School of Medicine

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310006

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guosheng Wu, MD

Phone

+8617857310313

Ext

87236858

guosheng_wu@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Trial of Neoadjuvant mFOLFOXIRI Versus CRT in the EMVI Positive LARC

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