Recruiting

Study on the Safety of Trifluridine/Tipiracil for Patients with Dihydropyrimidine Dehydrogenase Deficiency and Metastatic Colorectal or Gastroesophageal Cancer

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What is this trial about?

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

This clinical trial is focused on studying the safety of a medication called Trifluridine/tipiracil in patients diagnosed with metastatic colorectal cancer or gastroesophageal cancer. These patients have a specific condition known as dihydropyrimidine dehydrogenase deficiency, which affects how their body processes certain chemotherapy drugs. The study aims to evaluate if Trifluridine/tipiracil can be a safer alternative to traditional chemotherapy drugs like 5-fluorouracil and capecitabine for these patients.

Participants in the study will receive Trifluridine/tipiracil as part of their first-line treatment for their cancer. The study will monitor the safety of this treatment over a period of time, specifically looking for any severe side effects. The trial will also assess how well the treatment controls the cancer, including measuring the disease control rate after two months of treatment. Other medications involved in the study include Nivolumab, Panitumumab, Bevacizumab, Trastuzumab, and Oxaliplatin, which may be used in combination with Trifluridine/tipiracil depending on the specific needs of the patient.

The study will last for several years, with regular assessments to check the health-related quality of life of the participants. This will be done using specific questionnaires designed for patients with colorectal or gastroesophageal cancer. The goal is to ensure that the treatment not only controls the cancer effectively but also maintains a good quality of life for the patients involved in the trial.

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
Initial treatment phase
The treatment begins with the administration of trifluridine/tipiracil as a replacement for traditional chemotherapy. This medication is taken orally in the form of film-coated tablets.
The dosage and frequency of the medication will be determined by the healthcare provider based on individual patient needs and medical condition.
Step 2
First evaluation
After two months of treatment, an evaluation is conducted to assess the disease control rate. This involves checking the response of the cancer to the treatment.
The evaluation will also monitor for any specific toxicities, such as digestive issues or neutropenia, which is a low level of a type of white blood cell.
Step 3
Ongoing treatment and monitoring
The treatment continues with regular monitoring for adverse events and treatment-related side effects. This includes serious adverse events and any changes in health status.
The healthcare team will assess the dose intensity of the treatment and make adjustments as necessary to ensure the best possible outcomes.
Step 4
Quality of life assessments
Throughout the trial, health-related quality of life is assessed using specific questionnaires. These assessments occur at the start of the trial and every two months thereafter.
The questionnaires are designed to evaluate the impact of the treatment on daily life and overall well-being.
Step 5
End of treatment evaluation
At the end of the treatment period, a final evaluation is conducted to determine the overall efficacy of the treatment.
This includes measuring progression-free survival, overall survival, and the objective response rate to the treatment.

Who can join the trial?

13 criteria

The patient must have signed a written consent form before any trial procedures. If the patient cannot sign, a trusted person can confirm the patient's consent in writing.
Women who can have children must have a negative pregnancy test within 7 days before starting the study treatment. Women who cannot have children include those who are postmenopausal or have had permanent sterilization (like tubal occlusion, hysterectomy, or removal of both fallopian tubes).
Women who can have children and men must agree to use effective birth control during the study and for up to 7 months after finishing the treatment.
The patient must be willing and able to attend scheduled visits, follow the treatment plan, and complete laboratory tests and other study procedures.
The patient must be part of the Social Security System or an equivalent system.
The patient must have a type of cancer called **adenocarcinoma** of the colon, rectum, or gastroesophageal area, which is confirmed by a test showing **proficient mismatch repair** or **microsatellite stable** (pMMR/MSS).
The cancer must be **metastatic**, meaning it has spread to other parts of the body, and cannot be removed by surgery.
There must be at least one measurable tumor according to specific guidelines called RECIST v1.1.
The patient must not have had any previous treatment for metastatic disease.
The patient must have a known **DPD deficiency**, which is a condition defined by a specific level of a substance called **plasma uracil** in the blood.
The patient must be at least 18 years old.
The patient must have an **ECOG performance status** of 0 or 1, which is a scale used to assess how well a patient can perform daily activities.
The patient must have adequate bone marrow, kidney, and liver function, as shown by laboratory tests done within 7 days before starting the study treatment.

Who cannot join the trial?

7 criteria

Patients who do not have a type of cancer called **metastatic adenocarcinoma** of the colon, rectum, or certain parts of the stomach and esophagus.
Patients who do not have a known **dihydropyrimidine dehydrogenase (DPD) deficiency**. This is a condition where the body has trouble breaking down certain medicines.
Patients who are not undergoing their first treatment for their cancer.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not male or female, as both genders are included in the study.
Patients who are not considered part of a vulnerable population, which means they might need extra protection or care.

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Verified sites

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

Centre Hospitalier Lyon Sud
Verified
Pierre Benite, France
Centre Hospitalier Universitaire Amiens Picardie
Verified
Amiens, France
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Trifluridine/tipiracil is a medication used in this clinical trial as an alternative chemotherapy option. It is being tested for its safety and effectiveness in patients with metastatic colorectal or gastroesophageal cancer who have a deficiency in an enzyme called dihydropyrimidine dehydrogenase (DPD). This medication is considered as a replacement for other chemotherapy drugs like 5-fluorouracil and capecitabine, which are typically used in treating these types of cancers. The trial aims to see if Trifluridine/tipiracil can be a safer and effective option for these patients.

Trifluridine

What is already known about the treatment

Trifluridine/Tipiracil – This medication is administered orally in tablet form. It is currently being studied in clinical trials as a potential alternative to traditional chemotherapy for certain types of metastatic colorectal and gastroesophageal cancers, particularly in patients with a deficiency in the enzyme dihydropyrimidine dehydrogenase (DPD). The main therapeutic indication is for patients with specific genetic profiles of these cancers who cannot tolerate standard chemotherapy. At the molecular level, Trifluridine works by incorporating into DNA and interfering with its function, while Tipiracil helps maintain Trifluridine's activity by inhibiting its breakdown. It is classified as an antineoplastic agent, specifically a nucleoside metabolic inhibitor.

Investigated diseases

Metastatic Colorectal Adenocarcinoma
This is a type of cancer that begins in the colon or rectum and has spread to other parts of the body. It typically progresses through stages, starting from the inner lining of the colon or rectum and potentially moving to nearby lymph nodes and distant organs. The disease can cause symptoms such as changes in bowel habits, blood in the stool, and abdominal discomfort. As it advances, it may lead to more severe symptoms depending on the organs affected by metastasis.
Metastatic Gastroesophageal Adenocarcinoma
This cancer originates in the lower esophagus, gastroesophageal junction, or stomach and spreads to other areas of the body. It often begins in the glandular cells lining these regions and can invade nearby tissues and lymph nodes. The progression of the disease can result in symptoms like difficulty swallowing, weight loss, and chest pain. As it metastasizes, it may affect other organs, leading to additional complications and symptoms.