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

NCT04423965 | Unknown Phase 2 FDA Drug

• 1 other identifier: TRICHEMO
• Study Type: interventional
• Target: 220
• 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 FOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC in contrast to the efficacy of standard Chemoradiotherapy (CRT).

Conditions

Locally Advanced Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• MFS

  metastasis free survival

  3 years

Secondary Outcomes (6)

• Tumor downstaging rate

  2 years

• pCR

  2 years

• RFS

  3 years

• DFS

  3 years

• OS

  5 years

Study Arms (2)

mFOLFOXIRI

EXPERIMENTAL

Patients receive 6 cycles of mFOLFOXIRI

Drug: mFOLFOXIRI

Chemoradiotherapy(CRT)

EXPERIMENTAL

Patients receive standard chemoradiotherapy

Combination Product: Chemoradiotherapy

Interventions

mFOLFOXIRI DRUG

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

mFOLFOXIRI

Chemoradiotherapy COMBINATION_PRODUCT

Capecitabine based chemoradiotherapy

Chemoradiotherapy(CRT)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Zhejiang Cancer Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Interventions

Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Guosheng Wu, MD

CONTACT

+8617857310313; guosheng_wu@zju.edu.cn

Weiqin Jiang, MD

CONTACT

+8615068117618; 1312028@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 9, 2020
• Study Start: May 12, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2025
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)