Locally Advanced Colon CancerPhase 2ELECLANCT04188158
Analysis of the Effectiveness of Neoadjuvant Chemotherapy in the Treatment of Colon Cancer Locally Advanced (ELECLA)
A Phase 2 study testing CAPECITABINE AND OXALIPLATIN in people with Locally Advanced Colon Cancer, run by Universidad de León at 1 site in Spain.
Trial summary
Effectiveness analysis of neoadjuvant chemotherapy in the treatment of locally advanced colon cancer. ELECLA trial Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Colon Cancer
- What is being tested?
- CAPECITABINE AND OXALIPLATIN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2017to 10 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Complejo Asistencial Universitario de Leon
León, 24071
Jorge Arredondo, DR., +34 987237400, jarredondo@outlook.es
Pilar De la Torre, +34 987237400, ptorref.asitec@saludcastillayleon.es
About this study
Official title: Analysis of the Effectiveness of Neoadjuvant Chemotherapy in the Treatment of Colon Cancer Locally Advanced
Effectiveness analysis of neoadjuvant chemotherapy in the treatment of locally advanced colon cancer. ELECLA trial
Read the 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.
- Conditions
- Locally Advanced Colon Cancer
- Being tested
- CAPECITABINE AND OXALIPLATIN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPECITABINE AND OXALIPLATINCombination product
Intervention Group: Neoadjuvant chemotherapy ( 3 cycles Capecitabine and oxaliplatin) + surgery + adjuvant chemotherapy (5 cycles Capecitabine and oxaliplatin)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 3 cycles XELOX + Surgery+ 5 cycles XELOX Receives: Combination Product: CAPECITABINE AND OXALIPLATIN |
| Control group | Other | Surgery + 8 cycles XELOX Receives: Combination Product: CAPECITABINE AND OXALIPLATIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the inclusion of the patient in the study to 5 years of follow-up or his death, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start10 Mar 2017
- Primary completion10 May 2023 (estimated)
- Study completion10 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Intervention Group: Neoadjuvant chemotherapy + surgery + adjuvant chemotherapy * Control group: surgery + adjuvant chemotherapy
- Masking
- None (open label)
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de León
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jorge Arredondo, Universidad de León
- Investigators
- JORGE ARREDONDO, DR., Principal investigator, COMPLEJO ASISTENCIAL UNIVERSITARIO DE LEON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188158
- Sponsor's protocol ID
- Nº AEMPS: 16-0553
- Other IDs
- 2016-002970-10, 2016
- Acronym
- ELECLA
- Status last verified
- Dec 2019
- First submitted
- 25 Nov 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38362850
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effectiveness of Neoadjuvant Chemotherapy in the Treatment of Colon Cancer Locally Advanced
- ClinicalTrials.gov ID
- NCT04188158
- Acronym / sponsor ID
- ELECLA / Nº AEMPS: 16-0553
- Conditions
- Locally Advanced Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Universidad de LeónUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 10 May 2023 (estimated)
- Study completion
- 10 Mar 2024 (estimated)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Intervention Group: Neoadjuvant chemotherapy + surgery + adjuvant chemotherapy * Control group: surgery + adjuvant chemotherapy
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Combination Product: CAPECITABINE AND OXALIPLATIN3 cycles XELOX + Surgery+ 5 cycles XELOX |
| Control group | Other | Combination Product: CAPECITABINE AND OXALIPLATINSurgery + 8 cycles XELOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- CLINICS
- OF IMAGE
- <!-- -->
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAPECITABINE AND OXALIPLATINIntervention Group: Neoadjuvant chemotherapy ( 3 cycles Capecitabine and oxaliplatin) + surgery + adjuvant chemotherapy (5 cycles Capecitabine and oxaliplatin) | Combination product | Control group, Intervention Group |
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Derived from this study: PubMed 38362850Arredondo 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.
- Spanish Registry of Clinical StudiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Locally Advanced Colon Cancer
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 2
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Colon and Rectal Cancer
RecruitingPhase 3
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
Colon Adenocarcinoma, Rectal Adenocarcinoma
Active, not recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced or Metastatic Solid Tumors, NSCLC
RecruitingPhase 1
A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
Solid Tumor, Non-Small-Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JORGE ARREDONDO, DR. principal investigator
COMPLEJO ASISTENCIAL UNIVERSITARIO DE LEON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAPECITABINE AND OXALIPLATIN in people with Locally Advanced Colon Cancer, run by Universidad de León at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JORGE ARREDONDO, DR. (+34 987237400, jarredondo@outlook.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04188158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.