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

NCT04170530 | Unknown Phase 2 FDA Drug

• 1 other identifier: TRICHEMO
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Rectal Cancer

Keywords

Extramural Vascular Invasion; Neoadjuvant; chemotherapy; mFOLFOXIRI

Outcome Measures

Primary Outcomes (1)

• MFS

  metastasis free survival

  Three years

Secondary Outcomes (7)

• Tumor downstaging rate

  2 years

• pCR

  2 years

• R0 rate

  2 years

• locoregional recurrence

  3 years

• DFS

  3 years

Study Arms (1)

mFOLFOXIRI

EXPERIMENTAL

patients received FOLFOXIRI alone for 6 cycles before surgery.

Drug: mFOLFOXIRI

Interventions

mFOLFOXIRI DRUG

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

Also known as: 5-FU, Oxaliplatin, Irinotecan

mFOLFOXIRI

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Interventions

Fluorouracil; Oxaliplatin; Irinotecan

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Hua M Hanju, M.D

CONTACT

+86 15088779188; tomorrow97@163.com

Jiang F Weiqin, M.D

CONTACT

+86 15068117618; 1312028@zju.edu.cn

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: Associate chief physician

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: January 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: January 1, 2022
• Last Updated: November 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)