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Neoadjuvant mFOLFOXIRI Chemotherapy Alone for Extramural Vascular Invasion Positive Locally Advanced Rectal Cancer

Primary Purpose

Locally Advanced Rectal Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

mFOLFOXIRI

About this trial

This is an interventional treatment trial for Locally Advanced Rectal Cancer focused on measuring Extramural Vascular Invasion, Neoadjuvant, chemotherapy, mFOLFOXIRI

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged ≥ 18 to 75 years at diagnosis;
ECOG status 0 or 1;
Signed informed consent; able to comply with study and/or follow- up procedures;
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

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 Type

Experimental

Arm Label

mFOLFOXIRI

Arm Description

patients received FOLFOXIRI alone for 6 cycles before surgery.

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

R0 rate

R0 resection rate

locoregional recurrence

The rate of local recurrence

DFS

disease-free survival

overall survival.

Reported Adverse events

The incidence of >=3 grade adverse events

Full Information

NCT ID

NCT04170530

First Posted

November 18, 2019

Last Updated

November 18, 2019

Sponsor

First Affiliated Hospital of Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04170530

Brief Title

Neoadjuvant mFOLFOXIRI Chemotherapy Alone for Extramural Vascular Invasion Positive Locally Advanced Rectal Cancer

Official Title

Neoadjuvant mFOLFOXIRI Chemotherapy Alone for Extramural Vascular Invasion(EMVI) Positive Rectal Cancer: A Phase II, Single-arm, Prospective Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

November 1, 2020 (Anticipated)

Study Completion Date

January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital of Zhejiang University

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 mFOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC.

Detailed Description

It is an investigator-initiated, single institution, prospective, single-arm clinical study to evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC.Patients of LARC with EMVI+ evaluated by pelvic magnetic resonance imaging (MRI) were enrolled in this trial. All EMVI+ LARC will receive the study regimen every 2 weeks for 6 cycles. MRI will be performed after 3 cycles of chemotherapy to assess clinical response.MRI was performed to assess clinical response after chemotherapy. 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).If the tumor response is good enough(partial response or complete response), the patient will receive another 3 cycles of FOLFOXIRI 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. All patients will receive 6 cycles of mFOLFOX6 or 4 cycles 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

Keywords

Extramural Vascular Invasion, Neoadjuvant, chemotherapy, mFOLFOXIRI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mFOLFOXIRI

Arm Type

Experimental

Arm Description

patients received FOLFOXIRI alone for 6 cycles before surgery.

Intervention Type

Drug

Intervention Name(s)

mFOLFOXIRI

Other Intervention Name(s)

5-FU, Oxaliplatin, Irinotecan

Intervention Description

irinotecan* 135 mg/m² + oxaliplatin 68 mg/m² + leucovorin 400 mg/m² + 5-FU 2400 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle

Primary Outcome Measure Information:

Title

MFS

Description

metastasis free survival

Time Frame

Three 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

R0 rate

Description

R0 resection rate

Time Frame

2 years

Title

locoregional recurrence

Description

The rate of local recurrence

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

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged ≥ 18 to 75 years at diagnosis; ECOG status 0 or 1; Signed informed consent; able to comply with study and/or follow- up procedures; 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 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

Hua M Hanju, M.D

Phone

+86 15088779188

Ext

87236858

tomorrow97@163.com

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

Jiang F Weiqin, M.D

Phone

+86 15068117618

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

Hua Hanju, M.D

Phone

+86 15088779188

Ext

87236858

tomorrow97@163.com

12. IPD Sharing Statement

Plan to Share IPD

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Neoadjuvant mFOLFOXIRI Chemotherapy Alone for Extramural Vascular Invasion Positive Locally Advanced Rectal Cancer

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