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

Universidad de León

Status and phase: Unknown; Phase 2

Conditions: Locally Advanced Colon Cancer

Treatments: Combination Product: CAPECITABINE AND OXALIPLATIN

Study type: Interventional

Funder types: Other

Identifiers

NCT04188158

2016-002970-10 (EudraCT Number)

Nº AEMPS: 16-0553

Details and patient eligibility

About

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

Full 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.

Enrollment: 238 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
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  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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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238 participants in 2 patient groups

Intervention Group

Experimental group

Description:

3 cycles XELOX + Surgery+ 5 cycles XELOX

Treatment:

Combination Product: CAPECITABINE AND OXALIPLATIN

Control group

Other group

Description:

Surgery + 8 cycles XELOX

Treatment:

Combination Product: CAPECITABINE AND OXALIPLATIN