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

Zhejiang University logo

Zhejiang University

Status and phase

Enrolling
Phase 2

Conditions

Locally Advanced Rectal Cancer

Treatments

Combination Product: Chemoradiotherapy
Drug: mFOLFOXIRI

Study type

Interventional

Funder types

Other

Identifiers

NCT04423965
TRICHEMO

Details and patient eligibility

About

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).

Full description

It is an investigator-initiated, multicentered, randomized controlled clinical study to evaluate the efficacy and safety of mFOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC in contrast to standard chemoradiotherapy. Patients of LARC with EMVI+ evaluated by pelvic magnetic resonance imaging (MRI) are enrolled in this trial. All patients will be randomized divided into two groups. Experimental group will receive 3 cycles of mFOLFOXIRI, followed to be performed MRI to assess clinical response. If the tumor response is good enough (partial response or complete response), the patient will receive another 3 cycles of mFOLFOXIRI 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. Control group will receive standard capecitabine based chemoradiotherapy. 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). All patients will receive 4 cycles of XELOX as adjuvant chemotherapy after TME.

Enrollment

220 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Aged ≥ 18 to 70 years at diagnosis;
  2. ECOG status 0-2;
  3. Diagnosis of rectal adenocarcinoma(Distal border of the tumor must be located < 12 cm from the anal verge);
  4. MRI examination diagnosed EMVI-positive;
  5. Tumor amenable to curative resection;
  6. 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
  7. Signed informed consent; able to comply with study and/or follow- up procedures

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

220 participants in 2 patient groups

mFOLFOXIRI
Experimental group
Description:
Patients receive 6 cycles of mFOLFOXIRI
Treatment:
Drug: mFOLFOXIRI
Chemoradiotherapy(CRT)
Experimental group
Description:
Patients receive standard chemoradiotherapy
Treatment:
Combination Product: Chemoradiotherapy

Trial contacts and locations

1

Loading...

Central trial contact

Weiqin Jiang, MD; Guosheng Wu, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems