Liver Metastasis Colon CancerNCT05362825
Surgery Outcome Treated by Neo-adjuvant Combination of Oxaliplatin, Irinotecan, Folinic Acid and Fluorouracil (FOLFOXIRI) Regimen in Synchronous Liver Limited Metastasis Colorectal Cancer
An observational study of Liver Metastasis Colon Cancer and Synchronous Neoplasm, run by Cho Ray Hospital at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Metastasis Colon Cancer, Synchronous Neoplasm
- What is being tested?
- Neo-adjuvant Chemotherapy FOLFOXIRI Regimen and synchronous resection surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 89 participants
- Where
- 1 siteVietnam
- Study dates
- 18 Feb 2022to 23 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will comprise patients with colorectal cancer with un-resectable synchronous liver-limited hepatic metastases
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Cho Ray hospital- 201 B Nguyen Chi Thanh, District 5
Ho Chi Minh City
Hao Dinh Thy Vuong, M.D, +84913122867, drthyhao@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Neo-adjuvant Chemotherapy FOLFOXIRI Regimen, synchronous resection surgery
- Keywords
- FOLFOXIRI
- Medical subject headings
- Neoplasms, Multiple Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neo-adjuvant Chemotherapy FOLFOXIRI RegimenDrug
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.
synchronous resection surgeryProcedure or surgery
Also called Liver-first surgery, Primary/Bowel-first Surgery, No surgery
Patients undergoing colorectal primary and liver resection in a single operation or staged curative procedure or no surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Neo-adjuvant Chemotherapy FOLFOXIRI Regimen; Procedure: synchronous resection surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resectable outcome
R0 resection rate of liver metastases; Intra operative accident; Post-operative accident
Measured: 8 weeks
Secondary outcomes (3)
Progression free survival
Measured: 5 years
Overall survival
Measured: 5 years
The incidence of chemotherapy related adverse events
Incidence of the adverse events in any grade; the serious adverse events
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start18 Feb 2022
- Primary completion20 Dec 2024 (estimated)
- Study completion23 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Liver Metastasis Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cho Ray Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vuong Dinh Thy Hao, Cho Ray Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362825
- Sponsor's protocol ID
- Cho Ray hospital
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 24889770Masi 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.
PubMed 15550581Souglakos 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.
PubMed 16508637Marques 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.
PubMed 28917269Hao VDT, Tri PM, My DT, Anh LT, Trung LV, Bac NH, Vuong NL. FOLFOXIRI for First-Line Treatment of Unresectable Colorectal Cancer with Liver Metastases in a Resource-Limited Setting. J Gastrointest Cancer. 2024 Oct 31;56(1):12. doi: 10.1007/s12029-024-01133-4.
PubMed 39480530
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Outcome Treated by Neo-adjuvant Chemotherapy FOLFOXIRI Regimen in Colorectal Cancer With Liver-limited Synchronous Metastases
- ClinicalTrials.gov ID
- NCT05362825
- Acronym / sponsor ID
- Cho Ray hospital
- Keywords
- FOLFOXIRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- Cho Ray HospitalUniversity, hospital or other
- Collaborators
- University of Medicine and Pharmacy at Ho Chi Minh City
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 23 Jan 2025 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Un-resectable synchronous liver limited metastasis colorectal cancer | – | Drug: Neo-adjuvant Chemotherapy FOLFOXIRI Regimen, Procedure: synchronous resection surgeryUn-resectable synchronous liver limited metastasis colorectal cancer patients undergoing neo-adjuvant chemotherapy FOLFOXIRI regimen, up to 12 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will comprise patients with colorectal cancer with un-resectable synchronous liver-limited hepatic metastases
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neo-adjuvant Chemotherapy FOLFOXIRI RegimenOxaliplatin 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. | Drug | Un-resectable synchronous liver limited metastasis colorectal cancer |
| synchronous resection surgeryAlso: Liver-first surgery, Primary/Bowel-first Surgery, No surgeryPatients undergoing colorectal primary and liver resection in a single operation or staged curative procedure or no surgery | Procedure or surgery | Un-resectable synchronous liver limited metastasis colorectal cancer |
Primary outcome
Resectable outcome
Time frame: 8 weeks
R0 resection rate of liver metastases; Intra operative accident; Post-operative accident
3 secondary outcomes
Progression free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
The incidence of chemotherapy related adverse events
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Results publication: PubMed 24889770Siriwardena 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.
- Results publication: PubMed 15550581Masi 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.
- Results publication: PubMed 16508637Souglakos 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.
- Results publication: PubMed 28917269Marques 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.
- Derived from this study: PubMed 39480530Hao VDT, Tri PM, My DT, Anh LT, Trung LV, Bac NH, Vuong NL. FOLFOXIRI for First-Line Treatment of Unresectable Colorectal Cancer with Liver Metastases in a Resource-Limited Setting. J Gastrointest Cancer. 2024 Oct 31;56(1):12. doi: 10.1007/s12029-024-01133-4.
- Individual participant dataSharing planned: Undecided
Related trials for Liver Metastasis Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
RecruitingObservational study
Cancer Experience Registry (CER) for Cancer Patients and Caregivers
Neoplasms, Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Metastasis Colon Cancer and Synchronous Neoplasm, run by Cho Ray Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Dinh Thy Vuong, MD (+84913122867, drthyhao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resectable outcome (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05362825, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.