All studies
Active not recruitingPHASE2, PHASE3INTERVENTIONAL

Individualized Treatment Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA

This study investigates ways to improve treatment for nasopharyngeal cancer that has not spread far. All patients first receive standard chemotherapy and radiation. After this, a blood test checks for genetic material from the Epstein-Barr virus (EBV). If no EBV is found, patients either continue with standard chemotherapy or are just observed. If EBV is still detected, patients are randomly assigned to receive either standard chemotherapy or a different chemotherapy combination. We are trying to find out if these tailored approaches, based on the EBV blood test, can help patients live longer and keep the cancer from coming back. The study also looks at side effects and quality of life.

At a glance

Status
Active not recruiting
Phase
PHASE2, PHASE3
Sponsor
NRG Oncology
Enrolment target
685
Start
21 Apr 2014
Estimated completion
01 Feb 2031

What is this study about?

This study is for people with nasopharyngeal cancer that hasn't spread to distant parts of the body. Nasopharyngeal cancer is a type of cancer that starts in the upper part of the throat, behind the nose.

The main idea behind this research is to see if we can use a blood test to help doctors choose the best treatment for each person. This blood test looks for traces of the Epstein-Barr virus (EBV) DNA. EBV is a common virus, but it's linked to nasopharyngeal cancer. All patients in this study will first receive the usual treatment, which is a combination of chemotherapy and radiation therapy. Chemotherapy uses medicines to kill cancer cells, and radiation therapy uses high-energy X-rays to destroy them.

After this initial treatment, a blood sample will be taken to check for EBV DNA. Depending on whether EBV DNA is still found in the blood, patients will then be put into different treatment groups. If no EBV DNA is found, we want to know if continuing with standard chemotherapy or simply watching carefully is better. If EBV DNA is still present, we will compare the standard chemotherapy drugs with a different combination of chemotherapy drugs. We hope to learn if these personalised approaches can lead to better outcomes for patients, by preventing the cancer from returning and improving their overall health and quality of life.

Key takeaways

  • This study evaluates personalised treatment for nasopharyngeal cancer based on a blood test.
  • All participants receive initial standard chemotherapy and radiation.
  • An EBV blood test after initial treatment guides further care.
  • The study aims to improve cancer outcomes and reduce recurrence.
  • Participation involves close monitoring and regular assessments.

Who may be eligible?

To join this study, you must have nasopharyngeal cancer that has been confirmed by a biopsy. This cancer should be at stages II, III, IVA, or IVB, meaning it's not yet spread to distant parts of your body. You also need to be at least 18 years old.

Before you can officially join, several tests are required. These include a physical exam, an assessment by a specialist doctor like an oncologist, and imaging scans such as an MRI or CT scan of your head and neck to understand the cancer's exact location. You will also need chest and abdominal scans to ensure the cancer hasn't spread elsewhere.

Crucially, your blood will be tested for the Epstein-Barr virus (EBV) DNA. For a specific part of the study, you must have detectable EBV DNA found in your blood before you start treatment.

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 nasopharyngeal cancer confirmed by a biopsy?
  2. Is my cancer at stage II, III, IVA, or IVB, and not spread to distant body parts?
  3. Am I 18 years old or older?
  4. Have I had or can I get an MRI or CT scan of my head and neck?
  5. Am I willing to have blood tests to check for the EBV virus?
Answer every question to see your result.

What does participation involve?

If you join this study, you will first undergo standard treatment, which includes radiation therapy five days a week for about six and a half weeks, along with a chemotherapy drug called cisplatin given once a week. After this initial chemotherapy and radiation, a blood sample will be taken to check for EBV DNA.

What happens next depends on your EBV DNA test results. If no EBV DNA is found, you will be randomly assigned to either receive more standard chemotherapy (cisplatin and fluorouracil) or to be closely observed without further chemotherapy. If EBV DNA is still detected, you will be randomly assigned to receive either standard chemotherapy (cisplatin and fluorouracil) or a different chemotherapy combination (gemcitabine and paclitaxel).

Throughout the study, you will have regular visits for check-ups, blood tests, and imaging scans to monitor your health and the cancer. There will also be assessments to understand your quality of life. The total duration of participation will depend on which treatment group you are in and how you respond to treatment, and will include follow-up appointments after your main treatment ends.

Potential risks and benefits

Participating in this study might offer potential benefits, as you would be receiving close monitoring and potentially a treatment tailored to your specific cancer, which could be more effective. However, there are also potential risks involved, including side effects from the chemotherapy and radiation, which can range from mild to severe, and the possibility that the new treatment approaches may not be better than standard care. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (215)

  • University of Alabama at Birmingham Cancer Center
    Verified postcode
    Birmingham, United States
  • The Kirklin Clinic at Acton Road
    Verified postcode
    Birmingham, United States
  • Banner University Medical Center - Tucson
    Verified postcode
    Tucson, United States
  • Sutter Cancer Centers Radiation Oncology Services-Auburn
    Verified postcode
    Auburn, United States
  • Alta Bates Summit Medical Center-Herrick Campus
    Verified postcode
    Berkeley, United States
  • Mills-Peninsula Medical Center
    Verified postcode
    Burlingame, United States
  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
    Verified postcode
    Cameron Park, United States
  • City of Hope Comprehensive Cancer Center
    Verified postcode
    Duarte, United States
  • Kaiser Permanente Dublin
    Verified postcode
    Dublin, United States
  • Fresno Cancer Center
    Verified postcode
    Fresno, United States
  • UC San Diego Moores Cancer Center
    Verified postcode
    La Jolla, United States
  • Memorial Medical Center
    Verified postcode
    Modesto, United States

Common questions

What is nasopharyngeal cancer?

It's a type of cancer that starts in the upper part of the throat, behind your nose.

What is EBV DNA and why is it important?

EBV DNA is genetic material from the Epstein-Barr virus. For this study, finding it in your blood helps doctors decide which treatment might be best for you.

Will I definitely get a new treatment if I join?

Not necessarily. If your blood test shows no EBV DNA after initial treatment, you might be observed, or get standard chemotherapy. If EBV is found, you'll be randomly chosen for either standard chemotherapy or a new combination.

What kind of side effects might I experience?

Chemotherapy and radiation can cause different side effects like tiredness, sickness, hair loss, or mouth sores. Your care team will discuss these with you.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any point without it affecting your standard 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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