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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Clinica Universidad De Navarra

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Neoplasms [C04]

Trial duration

30 Jan 2025 → ongoing

Decision date (initial)

2025-01-30

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-519825-39-00

EudraCT number

2016-002970-10

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To determine if the proposed treatment with neoadjuvant chemotherapy, surgery and complementary chemotherapy increases Disease-Free Survival (DFS) at 2 years postoperatively, compared to the standard treatment, surgery and complementary chemotherapy.

Secondary objectives 9

1. To evaluate whether neoadjuvant chemotherapy, surgery and complementary chemotherapy increases DFS at 5 years postoperatively, compared to the standard treatment of surgery and complementary chemotherapy.
2. To evaluate whether neoadjuvant chemotherapy, surgery and complementary chemotherapy increases OS at 2 and 5 years postoperatively, compared to the standard treatment of surgery and complementary chemotherapy.
3. Compare the postoperative morbidity and mortality of neoadjuvant treatment in relation to standard treatment.
4. Analyze the toxicity in each group.
5. Analyze the degree of therapeutic completion in each group.
6. To assess the accuracy of CT to adequately diagnose LACC in the control group.
7. To assess the ability of CT to clinically quantify the degree of tumor response after neoadjuvant treatment in the intervention group.
8. To validate the usefulness of the scales commonly used in the assessment of the pathological tumor response in rectal cancer to determine this response in colon cancer, after neoadjuvant treatment.
9. Compare, in the group of patients over 70 years of age who receive neoadjuvant chemotherapy, whether the addition of oxaliplatin impacts the pathological response.

Conditions and MedDRA coding

Locally advanced colon cancer (LACC)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Histological confirmation of colon adenocarcinoma.
2. Patients of both sexes aged over 18 years.
3. Good general condition of the patient (Karnofsky>60% or ECOG<2).
4. Analysis at the time of inclusion with hemoglobin levels >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 signing of the Informed Consent.
7. Radiological signs, evaluated by CT, of T4 or T3 tumor infiltration >5 mm of transmural invasion.
8. With or without lymph node involvement by CT.
9. Without metastatic involvement in other organs (M0).
10. Radiologically resectable disease.
11. Who are going to undergo elective surgery with curative intent (R0).

Exclusion criteria 11

1. Significant comorbidity, uncontrolled angina or history of acute myocardial infarction in the last 6 months.
2. Personal history of another neoplasm in the last 5 years, except for melanoma.
3. Uncontrolled infection
4. Pregnancy or breastfeeding.
5. Peripheral neuropathy > grade 1.
6. Rectal cancer (< 15 cm from the anal verge or below the peritoneal reflection).
7. Presence of distant metastasis or peritoneal carcinomatosis.
8. Intestinal obstruction.
9. Existence of microsatellite instability
10. Refusal to participate or give written consent
11. Inability, at the discretion of the researcher, to understand the purpose of the study or comply with its procedures.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 2 years disease-free survival

Secondary endpoints 9

1. Disease-free survival (DFS) and overall survival (OS) at 5 years after randomization
2. Postoperative morbidity and mortality: Frequency and type of postoperative complications and transfusion requirements
3. Presence of local or distant recurrence and its location.
4. Toxicity, according to the CTCAE scale (Common Terminology Criteria for Adverse Events) version 4.0.
5. Degree of therapeutic completion in each of the groups.
6. Accuracy of CT to adequately diagnose LACC in the control group, studying the correlation between the staging of the preoperative CT and that given by the pathological analysis
7. Information provided by the restaging CT with the degree of regression at the pathological level: Sensitivity, Specificity, Positive/Negative Predictive Value will be calculated.
8. Utility of the scales commonly used in the assessment of the pathological tumor response in rectal cancer to determine this response in colon cancer, after neoadjuvant treatment.
9. In the group of patients over 70 years of age receiving neoadjuvant chemotherapy, whether the addition of oxaliplatin impacts the pathological response.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Clinica Universidad De Navarra

Sponsor organisation

Clinica Universidad De Navarra

Address

Pio XII Etorbidea 36

City

Pamplona

Postcode

31008

Country

Spain

Scientific contact point

Organisation

Clinica Universidad De Navarra

Contact name

Jorge Arredondo Chaves

Public contact point

Organisation

Clinica Universidad De Navarra

Contact name

Jorge Arredondo Chaves

Locations

1 EU/EEA country · 18 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications