Rectal Cancer Clinical Trial
— RENACIOfficial title:
RENACI Project: National Registry of Liver First Approach
NCT number | NCT04683783 |
Other study ID # | PI19/256 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2019 |
Est. completion date | November 30, 2020 |
Verified date | December 2020 |
Source | Hospital Miguel Servet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Liver metastases are present in 15-25% of patients with colorectal cancer at the time of diagnosis of the primary tumor, which is defined as synchronous liver metastases. Treatment for the potential cure of this disease includes surgical resection of both the primary tumor and liver metastases. The liver first approach was described by Mentha for patients with asymptomatic rectal tumors with with initially unresectable or borderline resectable liver metastases. There is little data in the scientific literature on how many patients scheduled for this strategy complete both surgeries and/or undergo the full chemo/radiation therapy.
Status | Completed |
Enrollment | 168 |
Est. completion date | November 30, 2020 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients = 18 year old. - Scheduled surgery for colorectal cancer with synchronous liver metastases using the liver first approach. - ASA score I-III. - They have signed the informed consent. Exclusion Criteria: - Patients under 18 year old. - ASA = IV. - Urgent surgery. - Patients who have not signed the informed consent. |
Country | Name | City | State |
---|---|---|---|
Spain | Mario Serradilla Martín | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
Hospital Miguel Servet | Asociación Española de Cirujanos |
Spain,
Adam R, De Gramont A, Figueras J, Guthrie A, Kokudo N, Kunstlinger F, Loyer E, Poston G, Rougier P, Rubbia-Brandt L, Sobrero A, Tabernero J, Teh C, Van Cutsem E; Jean-Nicolas Vauthey of the EGOSLIM (Expert Group on OncoSurgery management of LIver Metastas — View Citation
Adam R, de Gramont A, Figueras J, Kokudo N, Kunstlinger F, Loyer E, Poston G, Rougier P, Rubbia-Brandt L, Sobrero A, Teh C, Tejpar S, Van Cutsem E, Vauthey JN, Påhlman L; of the EGOSLIM (Expert Group on OncoSurgery management of LIver Metastases) group. M — View Citation
de Jong MC, van Dam RM, Maas M, Bemelmans MH, Olde Damink SW, Beets GL, Dejong CH. The liver-first approach for synchronous colorectal liver metastasis: a 5-year single-centre experience. HPB (Oxford). 2011 Oct;13(10):745-52. doi: 10.1111/j.1477-2574.2011 — View Citation
Ihnát P, Vávra P, Zonca P. Treatment strategies for colorectal carcinoma with synchronous liver metastases: Which way to go? World J Gastroenterol. 2015 Jun 14;21(22):7014-21. doi: 10.3748/wjg.v21.i22.7014. Review. — View Citation
Jegatheeswaran S, Mason JM, Hancock HC, Siriwardena AK. The liver-first approach to the management of colorectal cancer with synchronous hepatic metastases: a systematic review. JAMA Surg. 2013 Apr;148(4):385-91. doi: 10.1001/jamasurg.2013.1216. Review. — View Citation
Lam VW, Laurence JM, Pang T, Johnston E, Hollands MJ, Pleass HC, Richardson AJ. A systematic review of a liver-first approach in patients with colorectal cancer and synchronous colorectal liver metastases. HPB (Oxford). 2014 Feb;16(2):101-8. doi: 10.1111/ — View Citation
Mayo SC, Pulitano C, Marques H, Lamelas J, Wolfgang CL, de Saussure W, Choti MA, Gindrat I, Aldrighetti L, Barrosso E, Mentha G, Pawlik TM. Surgical management of patients with synchronous colorectal liver metastasis: a multicenter international analysis. — View Citation
Mentha G, Majno PE, Andres A, Rubbia-Brandt L, Morel P, Roth AD. Neoadjuvant chemotherapy and resection of advanced synchronous liver metastases before treatment of the colorectal primary. Br J Surg. 2006 Jul;93(7):872-8. — View Citation
Regimbeau JM, Cosse C, Kaiser G, Hubert C, Laurent C, Lapointe R, Isoniemi H, Adam R. Feasibility, safety and efficacy of two-stage hepatectomy for bilobar liver metastases of colorectal cancer: a LiverMetSurvey analysis. HPB (Oxford). 2017 May;19(5):396- — View Citation
Sturesson C, Valdimarsson VT, Blomstrand E, Eriksson S, Nilsson JH, Syk I, Lindell G. Liver-first strategy for synchronous colorectal liver metastases - an intention-to-treat analysis. HPB (Oxford). 2017 Jan;19(1):52-58. doi: 10.1016/j.hpb.2016.10.005. Ep — View Citation
Tsoulfas G, Pramateftakis MG. Management of rectal cancer and liver metastatic disease: which comes first? Int J Surg Oncol. 2012;2012:196908. doi: 10.1155/2012/196908. Epub 2012 Jun 20. — View Citation
Waisberg J, Ivankovics IG. Liver-first approach of colorectal cancer with synchronous hepatic metastases: A reverse strategy. World J Hepatol. 2015 Jun 18;7(11):1444-9. doi: 10.4254/wjh.v7.i11.1444. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients who complete the entire cycle | Percentage of patients who complete the cycle: neoadjuvant chemotherapy - liver surgery - CT / RT of the primary - surgery of the primary tumor | 90 days | |
Secondary | Mortality rate | Postoperative mortality including liver surgery and primary tumor | 90 days | |
Secondary | Morbidity rate | Postoperative morbidity including liver surgery and primary tumor (all type of postoperative complications) | 90 days |
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