Surgery Outcome Treated by Neo-adjuvant Combination of Oxaliplatin, Irinotecan, Folinic Acid and Fluorouracil (FOLFOXIRI) Regimen in Synchronous Liver Limited Metastasis Colorectal Cancer

Liver Metastasis Colon Cancer Clinical Trial

Official title:

Surgery Outcome Treated by Neo-adjuvant Chemotherapy FOLFOXIRI Regimen in Colorectal Cancer With Liver-limited Synchronous Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05362825
• Other study ID #: Cho Ray hospital
• Status: Recruiting
• Start date: February 18, 2022
• Est. completion date: January 23, 2025

Study information

• Verified date: May 2022
• Source: Cho Ray Hospital
• Contact: Hao Dinh Thy Vuong, MD
• Phone: +84913122867
• Email: drthyhao[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This single arm study aims to evaluate the rate of conversion therapy in patients with unresectable liver-limited metastatic colorectal cancer (mCRC) using FOLFOXIRI neoadjuvant regimen and to assess the other outcome including the response rate, the survival rate and the safety profile.

Description:

Patients with liver-only metastases colorectal cancer could potentially be cured following surgical resection of metastases. Recent evidence suggest that a triplet chemotherapy regimen, FOLFOXIRI has been associated with higher R0 resection. Eighty-nine eligible patients will be recruited at Cho Ray hospital in Vietnam. Patients will receive neoadjuvant FOLFOXIRI regimen every two weeks for up to 12 cycles and will undergo periodic imaging studies. The resectability of liver metastases will be assessed by a multidisciplinary team comprised of digestive surgeons, hepato-biliary surgeons, radiologists, and oncologists. This study will be helpful to establish a standard chemotherapy regimen for patients with liver-limited metastatic colorectal cancer. Moreover, this study will assess the surgical outcome, the response rate, the survival rate, the safety of triple drug chemotherapy and the association between conversion operable disease and various survival rate and patient's characteristics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 89
• Est. completion date: January 23, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients from 18 to 75 years
• Able to give informed consent
• Have a histological adenocarcinoma diagnosis of colorectal cancer
• Resected or operable colorectal primary tumor
• Initially unresectable liver lesion considered by multidisciplinary team (MDT)
• World Health Organisation performance status (ECOG PS) 0, 1
• Adequate complete blood count, liver and renal function

Exclusion Criteria:

• Prior history of other active malignancies
• Unmeasurable lesion according to RECIST criteria v.1.1
• Recurrence of colorectal cancer
• Resection or ablation of liver lesion
• Distant metastases outside the liver
• Patients who have received prior chemotherapy with Oxaliplatin, Irinotecan, Capecitabine, 5-Fluoro-uracil.
• Concomitant uncontrollable medical status ie. symptomatic cardiac disease, infarction within 24 months, uncontrollable cardiac dysrhythmia, active infectious disease
• Pathology of the liver lesion except adenocarcinoma metastasis from colorectal cancer.

Related Conditions & MeSH terms

• Liver Metastasis Colon Cancer
• Neoplasm Metastasis
• Synchronous Neoplasm

Intervention

Drug:
• Neo-adjuvant Chemotherapy FOLFOXIRI Regimen
Oxaliplatin 85mg/m2 IV; Irrinotecan 165mg/m2 IV; Leucovorin 400mg/m2 IV; 5-Fluorouracil 2400mg/m2 continuous infusion in 46 hours - every 2-week cycle, up to 12 cycles.

Procedure:
• synchronous resection surgery
Patients undergoing colorectal primary and liver resection in a single operation or staged curative procedure or no surgery

Locations

Country	Name	City	State
Vietnam	Cho Ray hospital- 201 B Nguyen Chi Thanh, District 5	Ho Chi Minh City

Sponsors (2)

Lead Sponsor	Collaborator
Cho Ray Hospital	University of Medicine and Pharmacy at Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

References & Publications (4)

Marques RP, Duarte GS, Sterrantino C, Pais HL, Quintela A, Martins AP, Costa J. Triplet (FOLFOXIRI) versus doublet (FOLFOX or FOLFIRI) backbone chemotherapy as first-line treatment of metastatic colorectal cancer: A systematic review and meta-analysis. Cr — View Citation

Masi G, Allegrini G, Cupini S, Marcucci L, Cerri E, Brunetti I, Fontana E, Ricci S, Andreuccetti M, Falcone A. First-line treatment of metastatic colorectal cancer with irinotecan, oxaliplatin and 5-fluorouracil/leucovorin (FOLFOXIRI): results of a phase — View Citation

Siriwardena AK, Mason JM, Mullamitha S, Hancock HC, Jegatheeswaran S. Management of colorectal cancer presenting with synchronous liver metastases. Nat Rev Clin Oncol. 2014 Aug;11(8):446-59. doi: 10.1038/nrclinonc.2014.90. Epub 2014 Jun 3. Review. — View Citation

Souglakos J, Androulakis N, Syrigos K, Polyzos A, Ziras N, Athanasiadis A, Kakolyris S, Tsousis S, Kouroussis Ch, Vamvakas L, Kalykaki A, Samonis G, Mavroudis D, Georgoulias V. FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin and irinotecan) vs FOLFIR — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between R0 procedure and patient's characteristics.	age, sex, ECOG PS, colon site, Carcinoembryonic antigen (CEA) level, RAS/ BRAF gene mutation, chemotherapy cycle numbers, Early tumor shrinkage; Depth of response; Surgery procedure; Liver lesion's number; Liver lesion's site, Liver lesion's dimension	8 weeks
Other	Correlation between R0 procedure and survival time	Progression free survival (PFS) time, Overall survival (OS) time	5 years
Primary	Resectable outcome	R0 resection rate of liver metastases; Intra operative accident; Post-operative accident	8 weeks
Secondary	Progression free survival		5 years
Secondary	Overall survival		5 years
Secondary	The incidence of chemotherapy related adverse events	Incidence of the adverse events in any grade; the serious adverse events	2 weeks