Recruiting

Dose-Reduced Oxaliplatin and Drug Combination Study for Older Patients with Metastatic Colorectal Cancer

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical examination investigates the treatment of metastatic colorectal cancer, a type of cancer that starts in the colon or rectum and spreads to other parts of the body. The study involves older patients with this advanced stage of cancer. The goal is to find out if starting with a lower dose of chemotherapy is as effective as the full-dose treatment for keeping the disease from progressing. Chemotherapy medicines used in this study include Oxaliplatin, Calcium Folinate (sometimes known as folinic acid), Capecitabine, and Fluorouracil.

The therapy involves different medications given either by injection, infusion, or in tablet form. Oxaliplatin is provided as a concentrate for infusion, which means it is mixed into a liquid and given through a vein. Calcium Folinate can be given by injection or infusion. Capecitabine comes in tablet form and is taken orally, while Fluorouracil is delivered by injection or infusion. The study compares the effects of reduced doses versus full doses of these treatments, while also considering the risk of side effects. A placebo may be used in some cases to compare the effectiveness against the actual drugs.

The main purpose of this study is to determine if these lower-dose treatments are not less effective than full-dose treatments when it comes to delaying cancer progression. Attention is also given to how patients handle the treatments, looking at things like quality of life and unforeseen hospital visits.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's purpose and procedures. Written informed consent is required to participate.
Eligibility criteria include being 70 years or older, having metastatic colorectal cancer, and being a candidate for first-line palliative chemotherapy.
Step 2
Treatment initiation
The treatment involves dose-reduced chemotherapy. The specific medications used are oxaliplatin, folinic acid, capecitabine, and fluorouracil.
Oxaliplatin is administered as a concentrate for solution for infusion, given intravenously.
Folinic acid is provided as a solution for injection or infusion, also administered intravenously.
Capecitabine is taken orally in the form of film-coated tablets.
Fluorouracil is given as a solution for injection or infusion, administered intravenously.
Step 3
Treatment schedule
The treatment schedule is determined by the oncologist based on individual risk of toxicity. The frequency and duration of administration will be specified by the healthcare provider.
The goal is to demonstrate that dose-reduced chemotherapy is not inferior to full-dose treatment in terms of progression-free survival.
Step 4
Monitoring and assessments
Throughout the trial, regular monitoring and assessments will be conducted to evaluate the patient's response to treatment.
Primary endpoint is progression-free survival, while secondary endpoints include quality of life, physical functioning, and overall survival.
Step 5
Completion of treatment
The trial is estimated to end by December 2028. The number of completed treatment cycles and any dose reductions during treatment will be recorded.
Unplanned hospitalizations and cumulative received dosage will also be monitored to assess cost-effectiveness.

Who can join the trial?

10 criteria

Patients must be aged 70 years or older.
Patients must have colorectal cancer that has spread to other parts of the body, known as distant metastases, and no options for localized treatment.
Patients should be candidates for first-line palliative chemotherapy, which is treatment aimed at relieving symptoms and improving quality of life, as determined by their treating cancer doctor (oncologist).
Patients must be able to understand the Dutch language.
Patients need to provide written informed consent, which means they agree to participate in the study after being fully informed about it.
Patients must have adequate bone marrow and organ function, which means their body is working well enough to handle the treatment. This is checked by specific blood tests:
- Absolute neutrophil count (ANC) should be greater than 1.5 x 10^9 mmol/L. Neutrophils are a type of white blood cell important for fighting infections.
- Hemoglobin (Hb) should be greater than 6.0 mmol/L. Hemoglobin is a protein in red blood cells that carries oxygen.
- Platelets should be greater than 100 x 10^9/L. Platelets help with blood clotting.
- Serum bilirubin should be less than or equal to 2 times the upper limit of normal (ULN). Bilirubin is a substance made by the liver.
- Serum transaminases should be less than or equal to 3 times ULN if there are no liver metastases, or less than or equal to 5 times ULN if there are liver metastases. Transaminases are enzymes that help with liver function.

Who cannot join the trial?

6 criteria

Patients who have a different type of cancer other than metastatic colorectal cancer cannot participate. Metastatic means the cancer has spread to other parts of the body.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who are not able to receive chemotherapy treatment due to other health conditions cannot participate.
Patients who are already participating in another clinical trial cannot participate.
Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate cannot participate.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands
Sint Franciscus Vlietland Groep Stichting
Responsive
Rotterdam, The Netherlands

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

DOSe-reduced Chemotherapy
is a treatment approach in this trial where the amount of chemotherapy given to patients is reduced. This is being tested to see if it is as effective as the standard full-dose chemotherapy in treating advanced colorectal cancer, especially in older patients. The goal is to maintain the effectiveness of the treatment while potentially reducing side effects and improving the quality of life for patients.
Full-dose Chemotherapy
is the standard treatment being compared in this trial. It involves administering the usual amount of chemotherapy drugs to treat advanced colorectal cancer. This approach is being used as a benchmark to evaluate the effectiveness and safety of the dose-reduced chemotherapy.

What is already known about the treatment

Fluorouracil – This medication is typically administered intravenously and is used in the treatment of metastatic colorectal cancer. It is well-established in medical literature as a key component of chemotherapy regimens for this condition. The main therapeutic indication is to slow or stop the growth of cancer cells. At the molecular level, fluorouracil works by inhibiting the synthesis of DNA in cancer cells, thereby preventing their division and growth. It is classified as an antimetabolite in pharmacology.

Investigated diseases

Metastatic Colorectal Cancer – This is a type of cancer that begins in the colon or rectum and spreads to other parts of the body, such as the liver or lungs. It typically starts as a growth, called a polyp, on the inner lining of the colon or rectum. Over time, some polyps can turn into cancer. Once the cancer cells spread beyond the colon or rectum, they can travel through the bloodstream or lymphatic system to other organs. The progression of the disease can vary, with some patients experiencing rapid spread while others may have a slower progression. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort.