Analysis of the Effectiveness of Neoadjuvant Chemotherapy in the Treatment of Colon Cancer Locally Advanced (ELECLA)
ELECLA
2 other identifiers
interventional
238
1 country
1
Brief Summary
Effectiveness analysis of neoadjuvant chemotherapy in the treatment of locally advanced colon cancer. ELECLA trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2017
Longer than P75 for phase_2
1 active site
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
March 10, 2017
CompletedFirst Submitted
Initial submission to the registry
November 25, 2019
CompletedFirst Posted
Study publicly available on registry
December 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2024
CompletedDecember 5, 2019
December 1, 2019
6.2 years
November 25, 2019
December 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-free survival (SLE) at 2 years
To determine whether the proposed treatment with neoadjuvant chemotherapy, surgery and complementary chemotherapy increases the disease-free survival (SLE) at 2 years postoperatively, compared with standard treatment, surgery and complementary chemotherapy.
From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.
Secondary Outcomes (3)
To assess whether neoadjuvant chemotherapy, surgery and complementary chemotherapy increases SLE 5 years postoperatively, compared to standard treatment of surgery and complementary chemotherapy
From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.
To evaluate whether neoadjuvant chemotherapy, surgery and complementary chemotherapy increase OS at 2 and 5 years postoperatively, in comparison with standard treatment of surgery and complementary chemotherapy.
From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.
To compare the postoperative morbidity and mortality of the neoadjuvant treatment in relation to the standard treatment
From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.
Study Arms (2)
Intervention Group
EXPERIMENTAL3 cycles XELOX + Surgery+ 5 cycles XELOX
Control group
OTHERSurgery + 8 cycles XELOX
Interventions
Intervention Group: Neoadjuvant chemotherapy ( 3 cycles Capecitabine and oxaliplatin) + surgery + adjuvant chemotherapy (5 cycles Capecitabine and oxaliplatin)
Eligibility Criteria
You may qualify if:
- CLINICS
- Histological confirmation of colon adenocarcinoma.
- Patients of both sexes with age over 18 years.
- Good general condition of the patient (Karnofsky\> 60% or ECOG (Eastern Cooperative Oncology Group) \<2).
- Absence of contraindication for chemotherapy.
- Acceptance and signature of the Informed Consent.
- OF IMAGE
- Radiological signs, evaluated by CT, of T4 or T3 tumor infiltration\> 5 mm of transmural invasion.
- With or without lymph node involvement by CT.
- No metastatic involvement in other organs (M0).
- Radiologically resectable disease. REFERENCES TO THE TREATMENT
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- That they will undergo elective surgery with curative intent (R0).
You may not qualify if:
- \. Important comorbidity, uncontrolled angina or a history of acute myocardial infarction in the last 6 months.
- \. Personal history of another malignancy in the last 5 years, with the exception of melanoma.
- \. Uncontrolled infection 4. Pregnancy or lactation. 5. Peripheral neuropathy\> grade 1. 6. Rectum cancer (\<15 cm of the anal margin or below peritoneal reflection). 7. Presence of distant metastasis or peritoneal carcinomatosis. 8. Intestinal obstruction. 9. Existence of microsatellite instability 10. Refusal to participate or to give written consent 11. Impossibility, at the investigator's discretion, to understand the purpose of the study or to comply with its procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Complejo Asistencial Universitario de Leon
León, 24071, Spain
Related Publications (1)
Arredondo J, Almeida A, Castanon C, Sanchez C, Villafane A, Tejedor P, Simo V, Baixauli J, Rodriguez J, Pastor C. The ELECLA trial: A multicentre randomised control trial on outcomes of neoadjuvant treatment on locally advanced colon cancer. Colorectal Dis. 2024 Apr;26(4):745-753. doi: 10.1111/codi.16908. Epub 2024 Feb 16.
PMID: 38362850DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JORGE ARREDONDO, DR.
COMPLEJO ASISTENCIAL UNIVERSITARIO DE LEON
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PRINCIPAL INVESTIGATOR
Study Record Dates
First Submitted
November 25, 2019
First Posted
December 5, 2019
Study Start
March 10, 2017
Primary Completion
May 10, 2023
Study Completion
March 10, 2024
Last Updated
December 5, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share