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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800019986

Enrollment

Unknown

Registered

2018-12-11

Start date

2019-01-01

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EMVI-positive Locally Advanced Rectal Cancer

Interventions

Case series:mFOLFOXIRI

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

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

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;

Design outcomes

Primary

Measure	Time frame
metastasis free survival [ Time Frame: Three years ];	—

Secondary

Measure	Time frame
pathologic complete response rate;The rate of local recurrence [ Time Frame: 3 years ];disease-free survival [Time Frame: 3 years] ;Overall survival [ Time Frame: Three years ];The incidence of >=3 grade adverse events;Pelvic complete resection rate;Tumor downstaging rate[Time Frame: 2 years];	—

Countries

China

Contacts

Public ContactHanju Hua

The First Affiliated Hospital, Zhejiang University School of Medicine

tomorrow97@163.com+86 15088779188

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026