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Analysis of the Effectiveness of Neoadjuvant Chemotherapy in the Treatment of Colon Cancer Locally Advanced (ELECLA) (ELECLA)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04188158
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Jorge Arredondo, Universidad de León

Brief Summary:
Effectiveness analysis of neoadjuvant chemotherapy in the treatment of locally advanced colon cancer. ELECLA trial

Condition or disease Intervention/treatment Phase
Locally Advanced Colon Cancer Combination Product: CAPECITABINE AND OXALIPLATIN Phase 2

Detailed Description:

Participants in this study selected patients according to homogeneous inclusion criteria and will be treated either with a uniform protocol of neoadjuvant chemotherapy, surgery and complementary chemotherapy (intervention group), or with the standard scheme of postoperative surgery and chemotherapy (control group ). All patients will be studied basally through clinical examinations and radiological and endoscopic tests usually used to reach the diagnosis of Locally Advanced Colon Cancer . In the group of patients receiving neoadjuvant treatment, the CT scan will be repeated after the completion of preoperative chemotherapy to restage the disease and quantify the degree of tumor response.

Finally, the project tries to determine whether the neoadjuvant treatment scheme increases disease-free survival (SLE) at 2 and 5 years and overall survival (OS) at 5 years. Likewise, the toxicity derived from chemotherapy treatment and perioperative morbidity and mortality will be analyzed to evaluate the feasibility and safety of the therapeutic procedure. The rate of completion of chemotherapy in both groups will also be compared.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • Intervention Group: Neoadjuvant chemotherapy + surgery + adjuvant chemotherapy
  • Control group: surgery + adjuvant chemotherapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Analysis of the Effectiveness of Neoadjuvant Chemotherapy in the Treatment of Colon Cancer Locally Advanced
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : May 10, 2023
Estimated Study Completion Date : March 10, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
3 cycles XELOX + Surgery+ 5 cycles XELOX
Combination Product: CAPECITABINE AND OXALIPLATIN
Intervention Group: Neoadjuvant chemotherapy ( 3 cycles Capecitabine and oxaliplatin) + surgery + adjuvant chemotherapy (5 cycles Capecitabine and oxaliplatin)

Control group
Surgery + 8 cycles XELOX
Combination Product: CAPECITABINE AND OXALIPLATIN
Intervention Group: Neoadjuvant chemotherapy ( 3 cycles Capecitabine and oxaliplatin) + surgery + adjuvant chemotherapy (5 cycles Capecitabine and oxaliplatin)




Primary Outcome Measures :
  1. Disease-free survival (SLE) at 2 years [ Time Frame: From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first. ]
    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.


Secondary Outcome Measures :
  1. To assess whether neoadjuvant chemotherapy, surgery and complementary chemotherapy increases SLE 5 years postoperatively, compared to standard treatment of surgery and complementary chemotherapy [ Time Frame: From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first. ]
    From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.

  2. 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. [ Time Frame: From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first. ]
    From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.

  3. To compare the postoperative morbidity and mortality of the neoadjuvant treatment in relation to the standard treatment [ Time Frame: From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first. ]
    From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CLINICS

    1. Histological confirmation of colon adenocarcinoma.
    2. Patients of both sexes with age over 18 years.
    3. Good general condition of the patient (Karnofsky> 60% or ECOG (Eastern Cooperative Oncology Group) <2).
    4. Analytical at the time of inclusion with figures of Hemoglobin> 10 g / dL; Leukocytes> 3.0 109 / L, Platelets> 100,000, Glomerular Filtration> 50 ml / min and Total Bilirubin <25 micromol / l.
    5. Absence of contraindication for chemotherapy.
    6. Acceptance and signature of the Informed Consent.
  • OF IMAGE

    1. Radiological signs, evaluated by CT, of T4 or T3 tumor infiltration> 5 mm of transmural invasion.
    2. With or without lymph node involvement by CT.
    3. No metastatic involvement in other organs (M0).
    4. Radiologically resectable disease. REFERENCES TO THE TREATMENT
    1. That they will undergo elective surgery with curative intent (R0).

Exclusion Criteria:

  • 1. Important comorbidity, uncontrolled angina or a history of acute myocardial infarction in the last 6 months.

    2. Personal history of another malignancy in the last 5 years, with the exception of melanoma.

    3. 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.


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): NCT04188158


Contacts
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Contact: JORGE ARREDONDO, DR. +34 987237400 jarredondo@outlook.es
Contact: PILAR DE LA TORRE +34 987237400 ptorref.asitec@saludcastillayleon.es

Locations
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Spain
Complejo Asistencial Universitario de Leon Recruiting
León, Spain, 24071
Contact: Jorge Arredondo, DR.    +34 987237400    jarredondo@outlook.es   
Contact: Pilar De la Torre    +34 987237400    ptorref.asitec@saludcastillayleon.es   
Principal Investigator: Jorge Arredondo, Dr.         
Sub-Investigator: Carmen Castañón, Dra.         
Sponsors and Collaborators
Universidad de León
Investigators
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Principal Investigator: JORGE ARREDONDO, DR. COMPLEJO ASISTENCIAL UNIVERSITARIO DE LEON

Additional Information:
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Responsible Party: Dr. Jorge Arredondo, PRINCIPAL INVESTIGATOR, Universidad de León
ClinicalTrials.gov Identifier: NCT04188158    
Other Study ID Numbers: Nº AEMPS: 16-0553
2016-002970-10 ( EudraCT Number )
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents