#1 Clinical Trials Search in Europe

Study on the Effects of Capecitabine and Oxaliplatin in Patients with Locally Advanced Colon Cancer

3 1 1 1

What is this study about?

This clinical trial is focused on studying the effects of a treatment for colon cancer, specifically in cases where the cancer is locally advanced. The treatment being tested is called neoadjuvant chemotherapy, which involves using chemotherapy before the main treatment to shrink the tumor. The medications used in this study are capecitabine and oxaliplatin. Capecitabine is taken orally in the form of a coated tablet, while oxaliplatin is administered as a concentrate for infusion, which means it is given through a vein.

The purpose of the study is to investigate how effective this chemotherapy is in improving the time patients remain free from the disease after treatment. Participants in the study will receive either the neoadjuvant chemotherapy or the standard treatment for colon cancer. The study will last for a period of up to 24 months, during which the effects of the treatment will be monitored and compared.

By participating in this study, researchers aim to gather information on whether the neoadjuvant chemotherapy can help improve outcomes for patients with locally advanced colon cancer. The ultimate goal is to determine if this approach can lead to better long-term results for patients by increasing the time they remain free from cancer after treatment.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Consent is required to participate.

Eligibility is confirmed based on specific criteria, including age, health status, and medical history.

2 initial assessment

An initial assessment is conducted to evaluate the patient’s health status. This includes a CT scan to confirm the stage of colon cancer.

Blood tests are performed to check blood cell counts and liver function.

3 treatment phase

The treatment involves neoadjuvant chemotherapy, which is administered before surgery to shrink the tumor.

The patient receives two medications: capecitabine and oxaliplatin.

Capecitabine is taken orally. The dosage and frequency are determined by the healthcare provider based on individual patient needs.

Oxaliplatin is administered through an injection. The frequency and dosage are also tailored to the patient’s condition.

4 monitoring and follow-up

Regular monitoring is conducted to assess the patient’s response to treatment and manage any side effects.

Follow-up appointments are scheduled to evaluate the effectiveness of the chemotherapy and plan further treatment if necessary.

5 end of trial

The trial aims to assess the two-year disease-free survival rate in patients with locally advanced colon cancer.

The estimated end date for the trial is December 31, 2026.

Who Can Join the Study?

  • The patient must have colon cancer that is locally advanced. This means the cancer is in the colon and has grown into nearby tissues but not spread to distant parts of the body.
  • The cancer must be T3 (tumor has grown into the outer layers of the colon) or T4 (tumor has grown through the outer layers and into nearby organs) as confirmed by a CT scan (a type of detailed imaging test).
  • The patient must be 18 years or older.
  • The patient must have a Performance Status (PS) of 0-2. This is a measure of how well the patient can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • The patient must have certain levels of blood cells: ANC (Absolute Neutrophil Count) of at least 1.5 x 109/l and Thrombocytes (platelets) of at least 100 x 109/l. These are measures of white blood cells and platelets, which are important for fighting infection and blood clotting.
  • The patient must have certain levels of liver function tests: Bilirubinemia (a measure of bilirubin in the blood) must be 3 times or less the upper normal level, and ALAT (a liver enzyme) must be 5 times or less the upper normal value.
  • The patient must agree to participate in translational research, which involves studying samples like blood or tissue to understand the disease better.
  • If the patient is a fertile woman, she must have a negative pregnancy test and use secure contraceptives during the study and for 3 months after treatment to prevent pregnancy.
  • The patient must provide written and oral informed consent, meaning they understand the study and agree to participate.

Who Cannot Join the Study?

  • Patients who have had another type of cancer in the past 5 years, except for skin cancer that is not melanoma.
  • Patients with serious heart problems, such as heart failure or a recent heart attack.
  • Patients with severe liver disease, which means the liver is not working well.
  • Patients with severe kidney disease, which means the kidneys are not working well.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an active infection that needs treatment with antibiotics.
  • Patients who have a known allergy to the drugs used in the study.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have a mental health condition that makes it hard to understand or follow the study instructions.
  • Patients who have had major surgery in the last 4 weeks.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Aalborg University Hospital Aalborg Denmark
Rigshospitalet Copenhagen Denmark
Sygehus Soenderjylland Soenderborg Aabenraa Denmark
Hedfik Hiqkkget Herlev Denmark
Hzkfz Bjzqfg Hq Bergen Norway

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
02.09.2013
Norway Norway
Not recruiting
02.09.2013

Trial locations

Investigated drugs:

Neoadjuvant Chemotherapy is a treatment given before the main treatment. In this trial, it is used to shrink tumors in patients with locally advanced colon cancer. The goal is to make the cancer easier to remove with surgery and to improve the chances of disease-free survival. This approach is being compared to the standard treatment to see if it offers better outcomes for patients.

Investigated diseases:

Colon Cancer – Colon cancer is a type of cancer that begins in the large intestine, which is the final part of the digestive tract. It typically starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. As the disease progresses, it can invade and destroy normal tissue nearby and may spread to other parts of the body. The progression of colon cancer can vary, with some cases growing slowly and others more rapidly. Early stages may not show symptoms, but as it advances, symptoms like changes in bowel habits, blood in the stool, and abdominal discomfort may occur.

Trial ID:
2024-514294-22-01
Protocol code:
NeoCol
NCT ID:
NCT01918527
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of Dostarlimab for Patients with Untreated Stage III Resectable Colon Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Study on the Effectiveness of Neoadjuvant Chemotherapy with Oxaliplatin and Capecitabine for Patients with Locally Advanced Colon Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain