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

Primary Purpose

Locally Advanced Colon Cancer

Status

Recruiting

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

CAPECITABINE AND OXALIPLATIN

About this trial

This is an interventional treatment trial for Locally Advanced Colon Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Complejo Asistencial Universitario de LeonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention Group

Control group

Arm Description

3 cycles XELOX + Surgery+ 5 cycles XELOX

Surgery + 8 cycles XELOX

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04188158

First Posted

November 25, 2019

Last Updated

December 4, 2019

Sponsor

Universidad de León

1. Study Identification

Unique Protocol Identification Number

NCT04188158

Brief Title

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

Acronym

ELECLA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Recruiting

Study Start Date

March 10, 2017 (Actual)

Primary Completion Date

May 10, 2023 (Anticipated)

Study Completion Date

March 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad de León

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Colon Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Intervention Group: Neoadjuvant chemotherapy + surgery + adjuvant chemotherapy Control group: surgery + adjuvant chemotherapy

Masking

None (Open Label)

Allocation

Randomized

Enrollment

238 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

3 cycles XELOX + Surgery+ 5 cycles XELOX

Arm Title

Control group

Arm Type

Other

Arm Description

Surgery + 8 cycles XELOX

Intervention Type

Combination Product

Intervention Name(s)

CAPECITABINE AND OXALIPLATIN

Intervention Description

Intervention Group: Neoadjuvant chemotherapy ( 3 cycles Capecitabine and oxaliplatin) + surgery + adjuvant chemotherapy (5 cycles Capecitabine and oxaliplatin)

Primary Outcome Measure Information:

Title

Disease-free survival (SLE) at 2 years

Description

Time Frame

From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.

Secondary Outcome Measure Information:

Title

To assess whether neoadjuvant chemotherapy, surgery and complementary chemotherapy increases SLE 5 years postoperatively, compared to standard treatment of surgery and complementary chemotherapy

Description

From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.

Time Frame

From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.

Title

Description

From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.

Time Frame

From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.

Title

To compare the postoperative morbidity and mortality of the neoadjuvant treatment in relation to the standard treatment

Description

From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.

Time Frame

From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). 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. 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

JORGE ARREDONDO, DR.

Phone

+34 987237400

jarredondo@outlook.es

First Name & Middle Initial & Last Name or Official Title & Degree

PILAR DE LA TORRE

Phone

+34 987237400

ptorref.asitec@saludcastillayleon.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JORGE ARREDONDO, DR.

Organizational Affiliation

COMPLEJO ASISTENCIAL UNIVERSITARIO DE LEON

Official's Role

Principal Investigator

Facility Information:

Facility Name

Complejo Asistencial Universitario de Leon

City

León

ZIP/Postal Code

24071

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jorge Arredondo, DR.

Phone

+34 987237400

jarredondo@outlook.es

First Name & Middle Initial & Last Name & Degree

Pilar De la Torre

Phone

+34 987237400

ptorref.asitec@saludcastillayleon.es

First Name & Middle Initial & Last Name & Degree

Jorge Arredondo, Dr.

First Name & Middle Initial & Last Name & Degree

Carmen Castañón, Dra.

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://reec.aemps.es/reec/public/web.html

Description

Spanish Registry of Clinical Studies

Learn more about this trial

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

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