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Chemotherapy for Resectable Colorectal Liver Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04513457
Recruitment Status : Active, not recruiting
First Posted : August 14, 2020
Last Update Posted : August 14, 2020
Sponsor:
Collaborator:
Marcello Di Martino
Information provided by (Responsible Party):
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Brief Summary:

There is a degree of uncertainty regarding the role of perioperative chemotherapy (CTx) in the treatment of resectable colorectal liver metastases (CRLM). In the clinical practice, the combination of surgery and CTx is increasingly accepted as treatment for CRLM, especially in the context of patients with synchronous disease or metachronous disease with a high risk of recurrence. However, controversy exists whether all patients with resectable CRLM benefit from perioperative CTx.

There is paucity of good quality studies on this topic. A pooled analysis of two phase III randomized clinical trial, closed prematurely because of slow accrual, showed a marginal statistical significance in favor of adjuvant CTx. Nevertheless, long term results of the EPOC trial founded benefit in disease free survival (DFS) with no difference in overall survival (OS) when perioperative CTx with FOLFOX4 was compared with surgery alone for resectable CRLM. Furthermore, a retrospective series from Ayez et al showed that patients with a high CRS benefit from neo-adjuvant CTx while in patients with a low risk profile did not. On the other side, another retrospective series from the MSKCC showed the timing of additional CTx for resectable CRLM was not associated with improved outcomes. The ongoing CHARISMA trial is currently comparing the outcomes of neo-adjuvant CTx followed by surgery versus surgery alone in high-risk patients with resectable CRLM.

This uncertainty regarding CRLM management may partly be due to the fact that these studies are not well powered to detect minor differences in long term outcomes and they often involved a very heterogenous group of patients with both synchronous and metachronous CRLM, not stratified by clinical risk score (CRS) as described by Fong et al.


Condition or disease Intervention/treatment
Metastatic Colorectal Cancer Metastatic Liver Cancer Other: Liver resection and Neoadjuvant chemotherapy Other: Liver resection and Adjuvant chemotherapy Other: Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy Procedure: Liver resection

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Study Type : Observational
Estimated Enrollment : 196 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Perioperative Chemotherapy Versus Surgery for Resectable Colorectal Liver Metastases: a Multicenter Propensity Score Matched Analysis on Long-term Outcomes
Actual Study Start Date : January 1, 2010
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Liver resection and Neoadjuvant chemotherapy
Liver resection and Neoadjuvant chemotherapy
Other: Liver resection and Neoadjuvant chemotherapy
Liver resection and Adjuvant chemotherapy
Liver resection and Adjuvant chemotherapy
Other: Liver resection and Adjuvant chemotherapy
Liver resection, Neoadjuvant and Adjuvant chemotherapy
Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy
Other: Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy
Liver resection
Liver resection
Procedure: Liver resection



Primary Outcome Measures :
  1. Overall survival based on perioperative treatment [ Time Frame: 5 years of follow-up ]
    Overall survival based on perioperative treatment

  2. Cancer survival based on perioperative treatment [ Time Frame: 5 years of follow-up ]
    Cancer survival based on perioperative treatment

  3. Disease-free survival based on perioperative treatment [ Time Frame: 5 years of follow-up ]
    Disease-free survival based on perioperative treatment

  4. Peri-operative morbidity [ Time Frame: 5 years of follow-up ]
    Peri-operative morbidity

  5. Peri-operative mortality [ Time Frame: 5 years of follow-up ]
    Peri-operative mortality


Secondary Outcome Measures :
  1. Overall survival, cancer survival and disease-free survival related with biological markers [ Time Frame: 5 years of follow-up ]
    Overall survival, cancer survival and disease-free survival related with biological markers

  2. Overall survival, cancer survival and disease-free survival related with hidden no resected liver lesions. [ Time Frame: 5 years of follow-up ]
    Overall survival, cancer survival and disease-free survival related with hidden no resected liver lesions.

  3. Overall survival, cancer survival and disease-free survival based related with simultaneous thermal ablation performed at the same time of the surgical excision. [ Time Frame: 5 years of follow-up ]
    Overall survival, cancer survival and disease-free survival based related with simultaneous thermal ablation performed at the same time of the surgical excision.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing liver resection for colorectal metastases between January 1, 2010 and December 31, 2014, inclusive
Criteria

Inclusion Criteria:

  • Patients older than 18 years with resectable liver metastases of histologically confirmed primary colorectal carcinoma.
  • Minimum follow-up of five years.

Exclusion Criteria:

  • Patients with extrahepatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04513457


Locations
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Spain
Hospital Universitario de la Princesa
Madrid, Spain, 28006
Sponsors and Collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Marcello Di Martino
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Responsible Party: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT04513457    
Other Study ID Numbers: Chemotherapy-liver-metastases
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa:
Colorectal liver metastases
Liver resection
Hepatectomy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes
Liver Extracts
Hematinics