CompletedPhase IIInterventional

PRIMUS001: A study looking at two different treatments for pancreatic cancer that has spread to other parts of the body

The PRIMUS 001 trial is testing two chemotherapy combinations for people with pancreatic cancer that has spread (metastatic pancreatic cancer). The goal is to see which combination works best at shrinking tumours and slowing cancer growth. Participants are placed into one of two treatment groups by chance. One group receives a standard combination called AG (nab-paclitaxel and gemcitabine). The other group receives a newer combination known as FOLFOX-A, which brings together several chemotherapy drugs. Doctors will also study tumour tissue samples taken from participants. By looking closely at the genes inside cancer cells, researchers hope to understand why certain treatments work better for some people. This study is open to adults who are well enough for treatment and have not had chemotherapy for advanced pancreatic cancer before. Taking part helps doctors improve treatments and discover more tailored care options for future patients.

At a glance

Status

Completed

Phase

Phase II

Sponsor

NHS Greater Glasgow and Clyde

Enrolment target

460

Start

01 Sep 2017

Estimated completion

31 Dec 2024

Metastatic pancreatic cancer

What is this study about?

Pancreatic cancer can be difficult to treat, especially when it has spread beyond the pancreas to other parts of the body. Standard chemotherapy can help slow down the disease and ease symptoms, but doctors want to find more effective drug combinations to give patients more time and a better quality of life.

The PRIMUS 001 trial is comparing two different chemotherapy approaches to see which one works better. One group of patients receives a standard treatment called AG, which is a pair of drugs called nab-paclitaxel and gemcitabine. The other group receives FOLFOX-A, which combines nab-paclitaxel with a well-established group of chemotherapy drugs called FOLFOX. Researchers want to see if FOLFOX-A helps patients live longer or keeps the tumour from growing for longer.

This trial is also part of a wider UK research project called Precision-Panc. As part of the study, researchers examine small samples of tumour tissue to look at the cancer's genetic make-up. Learning how different tumours respond to different medicines helps doctors move towards personalised medicine, where treatments can be matched to the unique features of each person's cancer.

Key takeaways

The trial compares two chemotherapy combinations for pancreatic cancer that has spread.
It aims to find out which treatment is better at shrinking tumours and slowing cancer growth.
The study includes genetic testing of tumour tissue to support personalised cancer care.
You must be 16 or older, fairly active, and new to chemotherapy for advanced disease.
Taking part is voluntary, and you can stop treatment or leave the study at any time.

Who may be eligible?

This trial is for adults aged 16 and over who have been diagnosed with pancreatic cancer that has spread to other areas of the body (advanced or metastatic cancer). To take part, you must also be enrolled in a broader UK study called Precision-Panc, which checks whether a sample of your cancer tissue is suitable for detailed genetic analysis.

You must be generally well enough to manage your daily self-care and get about, and you must not have received chemotherapy for advanced pancreatic cancer in the past. If you had chemotherapy after surgery in the past to stop cancer returning, you may still be able to join as long as at least six months have passed and you have recovered from any side effects.

Doctors will also run routine blood tests to make sure your liver, kidneys, and bone marrow are working safely before you begin. Women who could become pregnant will need a negative pregnancy test, and both men and women will need to use effective contraception during the study and for six months after finishing 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.

I am aged 16 or over.
I have been diagnosed with pancreatic cancer that has spread to other parts of my body.
I have not had chemotherapy for advanced (spread) pancreatic cancer before.
I am well enough to carry out daily self-care and light activities.
I am enrolled in, or willing to join, the Precision-Panc Master Protocol.

Answer every question to see your result.

What does participation involve?

If you take part, a computer will randomly choose whether you receive the standard AG chemotherapy or the FOLFOX-A combination. Both treatments are given as drips into a vein at the hospital day clinic. You will have regular hospital visits for your treatments, routine blood tests, and check-ups with your care team to see how you are feeling. Every few months, you will have CT or MRI scans to check how the cancer is responding. Treatment continues for as long as it is helping and the side effects are manageable. After your treatment ends, your care team will continue to check on your health during routine follow-up visits.

Potential risks and benefits

Taking part may help shrink your tumour, control your cancer, or provide valuable findings that help future patients. However, there is no guarantee that either treatment will work better than standard care. Like all chemotherapy, these medicines can cause side effects such as tiredness, sickness, hair thinning, a higher risk of infection, and numbness or tingling in your fingers or toes. Your medical team will monitor you closely and provide medicines to help manage side effects. Joining the study is completely up to you, and you can change your mind and leave at any time without your regular NHS care being affected.

Locations (31)

Beatson West of Scotland Cancer Centre
City only
Glasgow, Scotland
Addenbrooke's Hospital
Approximate
Cambridge, England
Bristol Haematology and Oncology Centre
City only
Bristol, England
The Christie NHS Foundation Trust
City only
Manchester, England
Guy's Hospital
Approximate
London, England
Ninewells Hospital
Unverified
Dundee, Scotland
Northern Ireland Cancer Centre
Unverified
Belfast, Northern Ireland
Royal Marsden Hospital
Unverified
Sutton, England
St George's Hospital
Unverified
London, England
University College Hospital
Unverified
London, England
University Hospital Southampton
Unverified
Southampton, England
Castle Hill Hospital
Unverified
Cottingham, England

Common questions

How is it decided which treatment I will get?

A computer selects your treatment group at random. This makes sure the trial is fair and gives a reliable comparison between the two chemotherapy combinations.

What is the Precision-Panc project?

Precision-Panc is a UK-wide research programme that studies tumour samples to help find the most effective, personalised cancer treatments for each patient.

How often will I need to visit the hospital?

You will need to visit the hospital day unit regularly for chemotherapy infusions, blood tests, and scans. Your hospital team will give you a clear schedule of your visits.

What happens if I get difficult side effects?

Your doctors can lower your dose, pause your treatment, or prescribe medicines to help ease your symptoms. Your comfort and safety always come first.

Can I leave the study if I decide it is not right for me?

Yes, you are free to leave the trial at any point. Your doctors will simply talk through other available treatment options with you.

How to find out more

Laura Cunningham

laura.cunningham.2@glasgow.ac.uk +44 (0)141 301 7246 Official trial record

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