NCT05362825

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2025

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

2.8 years

First QC Date

May 2, 2022

Last Update Submit

May 5, 2022

Conditions

Liver Metastasis Colon CancerSynchronous Neoplasm

Keywords

FOLFOXIRI

Outcome Measures

Primary Outcomes (1)

  • Resectable outcome

    R0 resection rate of liver metastases; Intra operative accident; Post-operative accident

    8 weeks

Secondary Outcomes (3)

  • Progression free survival

    5 years

  • Overall survival

    5 years

  • The incidence of chemotherapy related adverse events

    2 weeks

Other Outcomes (2)

  • Correlation between R0 procedure and patient's characteristics.

    8 weeks

  • Correlation between R0 procedure and survival time

    5 years

Study Arms (1)

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.

Drug: Neo-adjuvant Chemotherapy FOLFOXIRI RegimenProcedure: synchronous resection surgery

Interventions

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.

Un-resectable synchronous liver limited metastasis colorectal cancer
synchronous resection surgeryPROCEDURE

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

Also known as: Liver-first surgery, Primary/Bowel-first Surgery, No surgery
Un-resectable synchronous liver limited metastasis colorectal cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will comprise patients with colorectal cancer with un-resectable synchronous liver-limited hepatic metastases

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cho Ray hospital- 201 B Nguyen Chi Thanh, District 5

Ho Chi Minh City, Vietnam

RECRUITING

Related Publications (5)

  • 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.

    PMID: 24889770RESULT

  • 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.

    PMID: 15550581RESULT

  • 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.

    PMID: 16508637RESULT

  • 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.

    PMID: 28917269RESULT

  • Hao 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.

    PMID: 39480530DERIVED

MeSH Terms

Conditions

Neoplasms, Multiple Primary

Condition Hierarchy (Ancestors)

Neoplasms

Central Study Contacts

Hao Dinh Thy Vuong, MD

CONTACT

+84913122867drthyhao@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor, Medical Oncologist, Cho Ray Hospital at Ho Chi Minh City

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 5, 2022

Study Start

February 18, 2022

Primary Completion

December 20, 2024

Study Completion

January 23, 2025

Last Updated

May 11, 2022

Record last verified: 2022-05

Locations

VN(1)