FOLFOXIRI for Neoadjuvant Treatment of High-risk Locally Advanced Colorectal Cancer

NCT ID: NCT05018182

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-02
• Study Completion Date: 2022-08-02

Brief Summary

The main cause of recurrence after surgical treatment of colorectal cancer is distant metastasis. Neoadjuvant chemotherapy has potential benefits of improving the effectiveness of chemotherapy. Preoperative chemotherapy may eradicate microscopic metastatic cancer cells earlier than adjuvant chemotherapy, reduce cancer cell spillage during surgery, and lessen the invasiveness of surgical resection. The FOLFOXIRI regimen has been shown to have a high objective efficiency in advanced colorectal cancer. This phase II trial is to explore the pathological remission rate and safety of stage II/III locally advanced colon cancer with high risk of recurrence to FOLFOXIRI regimen of neoadjuvant chemotherapy alone.

Conditions

High-risk Locally Advanced Colorectal Cancer; Neoadjuvant Chemotherapy; FOLFOXIRI Regimen

Study Design

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

Study Groups

Neoadjuvant chemotherapy

4 cycles of neoadjuvant chemotherapy with FOLFOXIRI + operation + 5 cycles of adjuvant chemotherapy with XELOX

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin 85 mg/m² Q2w(2 h) before surgery rection and 130 mg/m² Q3w (2 h) after surgery

Irinotecan

Intervention Type: DRUG

Irinotecan 150 mg/m² ivgtt(1.5 h) Q2w before surgery rection

Folinic Acid

Intervention Type: DRUG

Folinic acid 400 mg/m² ivgtt(2 h) Q2w before surgery rection

5FU

Intervention Type: DRUG

5-FU 2800 mg/m² civ(46 h) Q2w before surgery rection

Capecitabine

Intervention Type: DRUG

Capecitabine 1000mg/m² d1-14 po Q3w after surgery rection

Interventions

Oxaliplatin

Oxaliplatin 85 mg/m² Q2w(2 h) before surgery rection and 130 mg/m² Q3w (2 h) after surgery

Intervention Type: DRUG

Irinotecan

Irinotecan 150 mg/m² ivgtt(1.5 h) Q2w before surgery rection

Intervention Type: DRUG

Folinic Acid

Folinic acid 400 mg/m² ivgtt(2 h) Q2w before surgery rection

Intervention Type: DRUG

5FU

5-FU 2800 mg/m² civ(46 h) Q2w before surgery rection

Intervention Type: DRUG

Capecitabine

Capecitabine 1000mg/m² d1-14 po Q3w after surgery rection

Intervention Type: DRUG

Other Intervention Names

Eloxatin; Campto; Leukovorin; 5-Fluorouracil; Xeloda

Eligibility Criteria

Inclusion Criteria

• Age: 18-75 years old; Sex: Male or female;
• WHO performance status of 0, 1 or 2
• Histologically proven colorectal carcinoma (defined as cancer that is located >10 cm from the anal verge by endoscopy)
• Unequivocal radiological evidence of locally advanced cancer based on thin slice spiral CT [defined as T4a/b or (and) N2 / fused lymph nodes or (and) positive extramural vascular invasion (EMVI +) or (and) circumferential resection margin (CRM) ≤ 2mm].
• No distant metastases (distant organ or (and) distant lymph node metastases) assessed by CT scan or other radiographic examination.
• For patients with T4b, R0 resection was expected to be achieved, including the necessary combined organ resection，by MDT discussion.
• No history of 5-Fu and platinum drug allergy.
• Adequate bone marrow function: Hb>9g/dl; PLT >100 x 10^9/l; WBC >3.5 x 10^9/l and ANC ≥1.5x10^9/l.
• Adequate hepatobiliary function: ASAT (aspartate aminotransferase) and ALAT (alanine aminotransferase) of 2.5 x ULN (upper limits of normal) or less, Alkaline phosphatase of 2.5 x ULN or less, total bilirubin 1.5 x upper normal level or less.
• Adequate renal biochemistry: GFR >50 ml/min calculated by the Wright or Cockroft formula or EDTA clearance >70 ml/min.
• For female and of childbearing potential, patient must have a negative pregnancy test ≤72hours prior to initiating study treatment and agree to avoid pregnancy during and for 6 months after study treatment. For male with a partner of childbearing potential, patient must agree to use adequate, medically approved, contraceptive precautions during and for 90 days after the last dose of study treatment
• Patient able and willing to provide written informed consent for the study.

Exclusion Criteria

• Patients with lynch syndrome
• Rectal cancer located 10 cm or less from the anal verge.
• Any patient for whom radiotherapy is advised by the MDT.
• Patient with evidence of distant metastases or peritoneal nodules (M1).
• Severe intestinal complications on initial clinical or imaging assessment: perforation, obstruction, uncontrollable bleeding.
• Another serious medical condition judged to compromise ability to tolerate neoadjuvant therapy and/or surgery.
• Pre-existing or concurrent other malignancies (including concurrent colon cancer), except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
• Pregnant or breastfeeding women.
• Patients with severe cardiovascular disease and diabetes mellitus that cannot be easily controlled.
• Persons with mental disorders.
• Patients with severe infections.
• Patients on thrombolytic/anticoagulant therapy, bleeding quality or coagulation disorders; or aneurysms, strokes, transient ischemic attacks, arteriovenous malformations in the past year.
• Previous history of renal disease with urine protein on urinalysis or clinically significant renal function abnormalities.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Meng Qiu

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weibing Leng, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Sichuan University

Locations

Sichuan University West China Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Meng Qiu, Ph.D

Role: CONTACT

qiumeng@wchscu.cn

+8602885423203

Weibing Leng, Ph.D

Role: CONTACT

s103470@stu.scu.edu.cn

+8602885423203

Facility Contacts

Weibing Leng

Role: primary

s103470@stu.scu.edu.cn

18980601776

References

Chen X, Leng W, Zhou Y, Yu Y, Meng W, Cao P, Wang Z, Qiu M. Pathological response and safety of FOLFOXIRI for neoadjuvant treatment of high-risk relapsed locally advanced colon cancer: study protocol for a single-arm, open-label phase II trial. BMJ Open. 2023 Jan 31;13(1):e062659. doi: 10.1136/bmjopen-2022-062659.

Reference Type: DERIVED

PMID: 36720570 (View on PubMed)

Other Identifiers

2021-010

Identifier Type: -

Identifier Source: org_study_id