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

NCT ID: NCT04170530

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-01-01

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.

Detailed 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.

Conditions

Locally Advanced Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mFOLFOXIRI

patients received FOLFOXIRI alone for 6 cycles before surgery.

Group Type: EXPERIMENTAL

mFOLFOXIRI

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

5-FU; Oxaliplatin; Irinotecan

Eligibility 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

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Hanju Hua

Associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hua M Hanju, M.D

Role: CONTACT

tomorrow97@163.com

+86 15088779188 ext. 87236858

Jiang F Weiqin, M.D

Role: CONTACT

1312028@zju.edu.cn

+86 15068117618 ext. 87236858

Facility Contacts

Hua Hanju, M.D

Role: primary

tomorrow97@163.com

+86 15088779188 ext. 87236858

Other Identifiers

TRICHEMO

Identifier Type: -

Identifier Source: org_study_id