Active not recruitingPHASE3INTERVENTIONAL

Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer

This study is testing a new way to treat certain bile duct (cholangiocarcinoma) and gallbladder cancers after surgery. Doctors want to see if a combination of chemotherapy drugs, gemcitabine and cisplatin, works better than the current standard treatment. The standard treatment is either observation for some patients or another chemotherapy drug called capecitabine. Both gemcitabine and cisplatin are commonly used cancer drugs. The aim is to find out if this newer combination can reduce the chances of the cancer coming back and help people live longer after their operation. This is a large study involving many hospitals, and people will be randomly assigned to receive either the new combination or the standard treatment.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrolment target

789

Start

01 Apr 2014

Estimated completion

01 Dec 2025

Cholangiocarcinoma Gall Bladder Carcinoma

What is this study about?

When people have surgery for certain bile duct or gallbladder cancers, doctors often give them extra treatment afterwards. This is called 'adjuvant therapy' and it's designed to kill any tiny cancer cells that might have been left behind, even if they can't be seen. The aim is to reduce the chance of the cancer coming back in the future. Until recently, sometimes after surgery, patients were just observed, or given a chemotherapy drug called capecitabine. Now, doctors are looking into whether a different combination of chemotherapy drugs, gemcitabine and cisplatin, might be more effective.

This study, called ACTICCA-1, wants to compare these two main approaches: the gemcitabine and cisplatin combination versus the standard treatment (which is either observation or capecitabine, depending on the situation). Both gemcitabine and cisplatin are established chemotherapy drugs used to treat various cancers, including some types of bile duct cancer. The trial aims to see if giving gemcitabine and cisplatin after surgery helps people stay cancer-free for longer and improves their overall health.

To make sure the study is fair, patients will be randomly assigned to one of the treatment groups – like flipping a coin. Neither you nor your doctor can choose which group you join. This helps researchers compare the treatments accurately. The study will last for 24 weeks, which means you'll receive treatment for about six months, and doctors will carefully monitor your progress throughout.

Key takeaways

A study for certain bile duct or gallbladder cancers after surgery.
Compares a new chemotherapy combination to standard treatment.
Aims to see if the new combination works better at preventing cancer return.
Participants will be randomly assigned to a treatment group.
Treatment lasts for 24 weeks with regular monitoring.

Who may be eligible?

To join this study, you would generally need to have been diagnosed with certain types of bile duct (cholangiocarcinoma) or gallbladder cancer that has been completely removed by surgery. The surgery must have happened recently, within 16 weeks before starting the chemotherapy treatment for the study. Your general health needs to be good enough to cope with chemotherapy, meaning you can look after yourself and are active for most of the day.

You also need to be at least 18 years old. Important body functions, like your blood, liver, and kidneys, need to be working well. You shouldn't have any serious ongoing infections or other types of cancer within the last three years (apart from very common and easily treated skin cancers or very early cervical cancer). Heart problems that are serious or uncontrolled would also prevent you from joining. The doctors leading the study will carefully check all these requirements to make sure it's safe for you to take part.

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.

Have you had surgery for bile duct or gallbladder cancer recently?
Is your general health good enough for chemotherapy treatment?
Are you 18 years old or older?
Are your kidney, liver, and blood functions within normal limits?
Do you have any other serious medical conditions like uncontrolled heart problems?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive chemotherapy treatment for 24 weeks (about six months). This will involve regular visits to the hospital for your chemotherapy drugs. You will also have scans or other imaging tests every 12 weeks throughout the treatment period to monitor your progress and check how the treatment is working. One of the treatment options, capecitabine, is a tablet you take at home, while gemcitabine and cisplatin are given as infusions in the hospital.

Your doctors will ask you to keep a diary of your treatments and any side effects you experience. After the 24-week treatment period, you will continue to have regular check-ups and monitoring for a longer time to see how the treatment affects your health in the long run. The total duration of your involvement in the study, including follow-up, will be explained by the study team.

Potential risks and benefits

Taking part in a clinical trial means you might have access to a new treatment combination that could potentially be more effective than current standard care. However, new treatments can also have side effects that aren't fully known or might be more severe than existing treatments. Chemo drugs like gemcitabine, cisplatin, and capecitabine can all cause tiredness, sickness, hair loss (less common with capecitabine), and other side effects. Your doctor will discuss the known risks and potential benefits with you carefully. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (67)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Bankstown Hospital
Verified postcode
Bankstown, Australia
Nepean Hospital Cancer Care
Verified postcode
Kingswood, Australia
St. George Hospital
Verified postcode
Kogarah, Australia
Prince of Wales Hospital
Verified postcode
Randwick, Australia
Calvary Mater Newcastle
Verified postcode
Waratah, Australia
Townsville Hospital
Verified postcode
Douglas, Australia
Royal Brisbane and Women's Hospital
Verified postcode
Herston, Australia
Princess Alexandra Hospital
Verified postcode
Woolloongabba, Australia
Flinders Medical Centre
Verified postcode
Bedford Park, Australia
Fiona Stanley Hospital Perth
Verified postcode
Murdoch, Australia
Sir Charles Gairdner Hospital
Verified postcode
Nedlands, Australia
St. John of God
Verified postcode
Subiaco, Australia

Common questions

What types of cancer is this study for?

This study is for certain types of bile duct cancer (cholangiocarcinoma) and gallbladder cancer that have been removed by surgery.

What is 'adjuvant chemotherapy'?

It's extra chemotherapy given after surgery to try and kill any remaining cancer cells and reduce the chance of the cancer coming back.

Will I be able to choose my treatment?

No, you will be randomly assigned to one of the treatment groups – like a lottery – to keep the study fair.

How long will the treatment part of the study last?

The chemotherapy treatment will last for 24 weeks, which is about six months.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time without it affecting your regular medical care.