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

Locally Advanced Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04170530
• Other study ID #: TRICHEMO
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: November 2019
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Hua M Hanju, M.D
• Phone: +86 15088779188
• Email: tomorrow97[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: January 1, 2022
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Aged = 18 to 75 years at diagnosis;

2. ECOG status 0 or 1;

3. Signed informed consent; able to comply with study and/or follow- up procedures;

4. Diagnosis of rectal adenocarcinoma;

5. Distal border of the tumor must be located < 12 cm from the anal verge;

6. MRI examination diagnosed EMVI-positive;

7. Tumor amenable to curative resection;

8. 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.

9. No renal disease that would preclude study treatment or follow-up

Exclusion Criteria:

1. Hypersensitivity to fluorouracil, oxaliplatin or irinotecan;

2. Patient had received pelvic radiotherapy;

3. Patient had received systemic chemotherapy;

4. History of invasive colon or rectal malignancy, regardless of disease-free interval;

5. Had metastatic disease;

6. Patient had second malignant disease within 5 years;

7. Uncontrolled co-morbid illnesses or other concurrent disease;

8. Patients refused to signed informed consent.

9. Pregnant and Nursing women;

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• mFOLFOXIRI
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

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MFS	metastasis free survival	Three years
Secondary	Tumor downstaging rate	the proportion of tumor downstaging to ypT0-2N0M0	2 years
Secondary	pCR	Pathologic complete response rate	2 years
Secondary	R0 rate	R0 resection rate	2 years
Secondary	locoregional recurrence	The rate of local recurrence	3 years
Secondary	DFS	disease-free survival	3 years
Secondary	OS	overall survival.	5 years
Secondary	Reported Adverse events	The incidence of >=3 grade adverse events	2 years