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Active not recruitingPHASE3INTERVENTIONAL

Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.

This research study is for people with advanced bowel cancer that has spread to other parts of the body (known as metastatic colorectal cancer). It's designed for those who can't have very strong chemotherapy treatments. The study is comparing two different treatment combinations. One group will receive a new drug called S95005, alongside a medicine called bevacizumab. The other group will receive an existing cancer drug, capecitabine, also with bevacizumab. Doctors want to find out if the S95005 combination is more effective at treating the cancer than the capecitabine combination. This is a 'Phase 3' study, which means it's one of the final steps before a new treatment might become available to more patients, if it proves to be better.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Institut de Recherches Internationales Servier
Enrolment target
856
Start
21 Mar 2019
Estimated completion
31 Dec 2026

What is this study about?

This study is looking into new ways to treat advanced bowel cancer (also called colorectal cancer) that has spread to other parts of the body. This stage of cancer is known as 'metastatic'. It's specifically for people who, for various health reasons, can't have the usual very strong chemotherapy treatments like those containing irinotecan or oxaliplatin. It's also for those whose cancer has spread and can't be completely removed by surgery.

The main goal of this particular study is to see if a new combination of medicines works better than a common existing treatment. Both combinations include a drug called bevacizumab. One group of patients will receive bevacizumab along with a new experimental medicine called S95005. The other group will receive bevacizumab with a well-known chemotherapy drug called capecitabine. By comparing these two approaches, doctors hope to find a more effective treatment option for this group of patients.

This is a 'Phase 3' clinical trial, which means it's a large and important step in testing new medicines. If the new combination proves to be significantly better than the current standard, it could potentially become a new treatment option for people with advanced bowel cancer who cannot tolerate more intensive therapies. Your participation could help improve future treatments for many others.

Key takeaways

  • Tests a new combination treatment (S95005 + bevacizumab) for advanced bowel cancer.
  • Compares it to a standard treatment (capecitabine + bevacizumab).
  • Aimed at patients who cannot have intensive chemotherapy.
  • This is a Phase 3 study, a key step in approving new treatments.
  • Participation contributes to new medical knowledge.
  • Always discuss with your doctor to understand if it's right for you.

Who may be eligible?

To join this study, you need to have bowel cancer that has been confirmed by a lab test and has spread to other parts of your body. Your doctors also need to know the specific type of your cancer cells (called 'RAS status'). This study is for you if you cannot have stronger chemotherapy treatments or surgery that would completely remove the cancer that has spread. You also shouldn't have had any other cancer drug treatment for your advanced bowel cancer before.

There are also some general health requirements. Your doctors will check that your blood, kidney, liver, and blood clotting functions are all working well enough. You also need to be able to carry out most of your normal daily activities without too much difficulty, as assessed by a score called ECOG performance status of 2 or less. This study is open to both men and women, aged 18 and over.

There are certain reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or might become pregnant during the study. You also can't have serious symptoms from cancer in your brain or have had major surgery recently (within 4 weeks). If you've had a bad reaction to similar medicines in the past, or if the study medicines (S95005, bevacizumab, capecitabine) have specific warnings or contraindications that apply to you, you wouldn't be able to participate. You also can't be involved in another similar medical study at the same time.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do I have bowel cancer that has spread?
  2. Can I not have very strong chemotherapy or surgery to remove all the spread cancer?
  3. Have I not yet received any drug treatment for my current advanced bowel cancer?
  4. Am I generally well enough to manage most daily activities?
  5. Am I not pregnant or breastfeeding, and not planning to become pregnant during the study?
  6. Do I currently have good kidney, liver, blood, and clotting function?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely have regular visits to the hospital or clinic. These visits will involve various checks and tests, such as blood tests, scans, and physical examinations, to monitor your health and how well the treatment is working. You will receive one of the two treatment combinations being compared, which will involve taking medication, possibly both as pills and through a drip (infusion).

The exact schedule of visits and tests will be explained to you by the study team, but generally, they will be more frequent at the beginning of the study and might become less frequent over time. The study will continue as long as the treatment is helping you and you are not experiencing significant side effects. There will also be a follow-up period after you finish the treatment to see how you are doing long-term. The total duration of your participation, including follow-up, will vary depending on your individual response to treatment.

Potential risks and benefits

Participating in this study might offer some potential benefits. You would receive a new treatment combination that could be more effective than existing options for your type of bowel cancer, or a standard treatment if you are in the control group, with very close monitoring of your health. You would also be contributing important information that could help doctors find better treatments for future patients with similar conditions. However, like all medical treatments, there are potential risks and side effects associated with the study medications. These can vary widely, and the study team will explain all known or expected side effects of S95005, bevacizumab, and capecitabine. It's important to weigh these potential risks against the potential benefits. Remember, joining a clinical trial is always voluntary. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (190)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Centro de Oncología e Investigación de Buenos Aires COIBA
    Verified postcode
    Berazategui, Argentina
  • Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit
    Verified postcode
    Buenos Aires, Argentina
  • Fundación Favaloro Oncology Unit
    Verified postcode
    Buenos Aires, Argentina
  • Instituto Alexander Fleming
    Verified postcode
    Buenos Aires, Argentina
  • Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales
    Verified postcode
    Buenos Aires, Argentina
  • Centro Oncológico Riojano Integral CORI Fundación CORI para la Investigación y Prevención del Cáncer
    Verified postcode
    La Rioja, Argentina
  • Fundación COIR Centro Oncológico de Interación Regional
    Verified postcode
    Mendoza, Argentina
  • Centro Médico San Roque
    Verified postcode
    San Miguel de Tucumán, Argentina
  • Instituto de Oncología de Rosario
    Verified postcode
    Santa Fe, Argentina
  • ISIS Centro especializado
    Verified postcode
    Santa Fe, Argentina
  • Blacktown Hospital Cancer and Haematology Centre
    Verified postcode
    Blacktown, Australia
  • Frankston Private Peninsula and Southeast Oncology Group
    Verified postcode
    Frankston, Australia

Common questions

What is 'metastatic colorectal cancer'?

It means bowel cancer that has spread from where it started to other parts of your body.

Why is this study for people who can't have intensive therapy?

This study is looking for gentler yet effective treatments for patients who might be too unwell or have other health conditions that prevent them from having stronger chemotherapy.

What is S95005?

S95005 is an experimental medicine being tested in this study to see if it works well against advanced bowel cancer.

Will I know which treatment I'm getting?

In some 'Phase 3' studies, patients are randomly assigned to a treatment group, and often neither you nor your doctor will know which treatment you are receiving until the study is over. The study team will explain how this works for this specific trial.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason. Your decision will not affect your ongoing medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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