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Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers

This study is looking at a new way to treat advanced cervical or vaginal cancer. It's comparing the standard treatment, which uses radiation therapy and a chemotherapy drug called cisplatin, with a new approach that adds an experimental drug called Triapine to the standard treatment. The main goal is to find out if adding Triapine helps people live longer and if it's better at stopping the cancer from growing or coming back. Researchers will also look at any side effects people might have with the new combination compared to the standard treatment. This information will help doctors understand the best ways to treat these cancers in the future.

At a glance

Results

Results from this study

Posted January 2024

Results have been published for this study.

Primary outcome
Overall Survival (OS) Rate at 3 Years
Estimate for probability of overall survival at 3 years by Kaplan-Meier method, where overall survival is defined as the time from randomization to time of death due to any cause or the date of last contact, whichever occurs first.
Full results on the registry

What is this study about?

Imagine you or someone you know has cervical or vaginal cancer that's at an advanced stage. Doctors already have ways to treat this, usually involving radiation therapy – which uses strong energy to kill cancer cells – combined with a chemotherapy drug called cisplatin. Chemotherapy drugs work by stopping cancer cells from growing and spreading.

This study is like a comparison, trying to find an even better way to fight these cancers. It's looking at whether adding a new drug called Triapine to the usual radiation and cisplatin treatment makes a difference. Triapine is thought to work by blocking important things cancer cells need to grow. By putting these two groups side-by-side, researchers can see if the group receiving Triapine, along with the standard treatment, has better outcomes.

The main idea is to see if adding Triapine helps people with these cancers live longer. The study will also be carefully checking for any side effects and how they compare between the two treatment groups. This vital research helps us learn if new treatments can improve how we care for people with cervical and vaginal cancers.

Key takeaways

  • New study for advanced cervical or vaginal cancer.
  • Compares standard treatment to standard treatment plus a new drug, Triapine.
  • Aims to see if Triapine improves how long people live and prevents cancer recurrence.
  • Careful monitoring for side effects in all participants.
  • Participation involves regular hospital visits for treatments and tests.

Who may be eligible?

This study is looking for women newly diagnosed with certain advanced stages of cervical or vaginal cancer. This includes specific types like squamous cell, adenocarcinoma, or adenosquamous carcinoma, and the cancer shouldn't be treatable by surgery alone. Doctors will check if your cancer has spread to nearby lymph nodes in your abdomen using a special scan, and if it has, you might not be able to join.

To be considered, you'll need to be generally well enough to take part in the study activities, as determined by your doctors. Your blood tests, liver function, and kidney function will need to be within a healthy range, as these are important for receiving chemotherapy safely. You should also have a good estimated life expectancy.

There are also a few things that would mean you couldn't join. For example, if you have diabetes that isn't under control, or if cancer has spread to your brain. You also can't be part of the study if you have HIV and are on certain medications, due to potential interactions.

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. Are you a woman with a new diagnosis of advanced cervical or vaginal cancer?
  2. Is your cancer not able to be treated by surgery alone?
  3. Do you generally feel well enough for regular treatments?
  4. Are your blood tests, kidney, and liver function generally healthy?
  5. Have you discussed your overall health with your doctor regarding suitability for a study like this?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be put into one of two groups by chance (like flipping a coin). One group will receive the standard treatment: radiation therapy and the chemotherapy drug cisplatin. The other group will receive radiation therapy, cisplatin, and the new drug, Triapine.

Your treatment will involve regular visits for radiation therapy. This might include different types of radiation, such as external beams or internal radiation called brachytherapy. You'll also receive cisplatin, likely through an IV, and if you're in the Triapine group, you'll receive that as well.

Throughout the study, you'll have various tests, including blood samples to check your health and how the treatment is affecting you, and special scans to monitor your cancer. Doctors will be very careful to monitor any side effects you might experience. The total duration of your active treatment period will depend on your specific cancer and how you respond, followed by regular check-ups to see how you're doing in the long term.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new drug that could be more effective than standard treatment, although this is not guaranteed. All treatments, including those in this study, have side effects. Doctors will carefully monitor you for any problems. You will have full access to your medical care while in the study and you can choose to leave the study at any time, for any reason, without it affecting your future medical care.

Locations (382)

  • University of Alabama at Birmingham Cancer Center
    Verified postcode
    Birmingham, United States
  • Anchorage Associates in Radiation Medicine
    Verified postcode
    Anchorage, United States
  • Alaska Breast Care and Surgery LLC
    Verified postcode
    Anchorage, United States
  • Alaska Oncology and Hematology LLC
    Verified postcode
    Anchorage, United States
  • Alaska Women's Cancer Care
    Verified postcode
    Anchorage, United States
  • Anchorage Oncology Centre
    Verified postcode
    Anchorage, United States
  • Katmai Oncology Group
    Verified postcode
    Anchorage, United States
  • Providence Alaska Medical Center
    Verified postcode
    Anchorage, United States
  • Fairbanks Memorial Hospital
    Verified postcode
    Fairbanks, United States
  • Banner University Medical Center - Tucson
    Verified postcode
    Tucson, United States
  • University of Arizona Cancer Center-North Campus
    Verified postcode
    Tucson, United States
  • CHI Saint Vincent Cancer Center Hot Springs
    Verified postcode
    Hot Springs, United States

Common questions

What is Triapine and how does it work?

Triapine is a new drug being tested that might stop cancer cells from growing by blocking certain things they need to survive.

What kind of cancers is this study for?

This study is for women with advanced stages of cervical or vaginal cancer that can't be fully removed with surgery.

Will I definitely get the new drug Triapine?

No, it's a 'randomised' study, meaning you'll be put into one of two groups by chance. One group gets Triapine, the other doesn't.

What are doctors hoping to learn from this study?

They want to know if adding Triapine helps people live longer and if it's better at stopping the cancer from coming back, compared to the usual treatment.

What happens if I decide I don't want to continue the study?

You can leave the study at any time, and it won't affect the care you receive from your doctors.

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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