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| Name | Class |
|---|---|
| University of Medicine and Pharmacy at Ho Chi Minh City | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neo-adjuvant Chemotherapy FOLFOXIRI Regimen | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Resectable outcome | R0 resection rate of liver metastases; Intra operative accident; Post-operative accident | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | 5 years | |
| Overall survival | 5 years | |
| The incidence of chemotherapy related adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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The study population will comprise patients with colorectal cancer with un-resectable synchronous liver-limited hepatic metastases
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Dinh Thy Vuong, MD | Contact | +84913122867 | drthyhao@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cho Ray hospital- 201 B Nguyen Chi Thanh, District 5 | Recruiting | Ho Chi Minh City | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24889770 | Result | 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. | |
| 15550581 | Result | 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. |
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| synchronous resection surgery | Procedure | Patients undergoing colorectal primary and liver resection in a single operation or staged curative procedure or no surgery |
|
|
Incidence of the adverse events in any grade; the serious adverse events |
| 2 weeks |
| Correlation between R0 procedure and survival time |
Progression free survival (PFS) time, Overall survival (OS) time |
| 5 years |
| 16508637 | Result | 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. |
| 28917269 | Result | 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. |
| 39480530 | Derived | 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. |
| ID | Term |
|---|---|
| D009378 | Neoplasms, Multiple Primary |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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