Surgery Outcome Treated by Neo-adjuvant Combination of Oxaliplatin, Irinotecan, Folinic Acid and Fluorouracil (FOLFOXIRI) Regimen in Synchronous Liver Limited Metastasis Colorectal Cancer
May 5, 2022 updated by: Vuong Dinh Thy Hao, Cho Ray Hospital
Surgery Outcome Treated by Neo-adjuvant Chemotherapy FOLFOXIRI Regimen in Colorectal Cancer With Liver-limited Synchronous Metastases
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
89
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hao Dinh Thy Vuong, MD
- Phone Number: +84913122867
- Email: drthyhao@gmail.com
Study Locations
-
-
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Ho Chi Minh City, Vietnam
- Recruiting
- Cho Ray hospital- 201 B Nguyen Chi Thanh, District 5
-
Contact:
- Hao Dinh Thy Vuong, M.D
- Phone Number: +84913122867
- Email: drthyhao@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study population will comprise patients with colorectal cancer with un-resectable synchronous liver-limited hepatic metastases
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Un-resectable synchronous liver limited metastasis colorectal cancer
Un-resectable synchronous liver limited metastasis colorectal cancer patients undergoing neo-adjuvant chemotherapy FOLFOXIRI regimen, up to 12 cycles.
|
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.
Patients undergoing colorectal primary and liver resection in a single operation or staged curative procedure or no surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resectable outcome
Time Frame: 8 weeks
|
R0 resection rate of liver metastases; Intra operative accident; Post-operative accident
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival
Time Frame: 5 years
|
5 years
|
|
|
Progression free survival
Time Frame: 5 years
|
5 years
|
|
|
The incidence of chemotherapy related adverse events
Time Frame: 2 weeks
|
Incidence of the adverse events in any grade; the serious adverse events
|
2 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between R0 procedure and patient's characteristics.
Time Frame: 8 weeks
|
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
|
|
Correlation between R0 procedure and survival time
Time Frame: 5 years
|
Progression free survival (PFS) time, Overall survival (OS) time
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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 II study with a simplified biweekly schedule. Ann Oncol. 2004 Dec;15(12):1766-72. doi: 10.1093/annonc/mdh470.
- 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 FOLFIRI (folinic acid, 5-fluorouracil and irinotecan) as first-line treatment in metastatic colorectal cancer (MCC): a multicentre randomised phase III trial from the Hellenic Oncology Research Group (HORG). Br J Cancer. 2006 Mar 27;94(6):798-805. doi: 10.1038/sj.bjc.6603011.
- 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. Crit Rev Oncol Hematol. 2017 Oct;118:54-62. doi: 10.1016/j.critrevonc.2017.08.006. Epub 2017 Aug 25.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 18, 2022
Primary Completion (Anticipated)
December 20, 2024
Study Completion (Anticipated)
January 23, 2025
Study Registration Dates
First Submitted
May 2, 2022
First Submitted That Met QC Criteria
May 2, 2022
First Posted (Actual)
May 5, 2022
Study Record Updates
Last Update Posted (Actual)
May 11, 2022
Last Update Submitted That Met QC Criteria
May 5, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cho Ray hospital
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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