SCALOP-2

A phase 2 trial looking at chemotherapy and radiotherapy in locally advanced pancreatic cancer (SCALOP-2)

Full title: A multi-centre randomised study of induction chemotherapy followed by capecitabine ( /- nelfinavir) with high or standard dose radiotherapy for locally advanced non-metastatic pancreatic cancer

Why is this trial being carried out?

Pancreatic cancer that has started growing into organs or blood vessels around the pancreas, meaning it is not possible to remove the cancer with surgery, is called locally advanced pancreatic cancer. People with this type of cancer are usually treated with chemotherapy. Some people are offered chemoradiotherapy, which is a combination chemotherapy and radiotherapy. The aim of chemoradiotherapy is for the chemotherapy drugs to make the cancer cells more sensitive to the radiotherapy, so that it is more effective. This treatment may help to control the cancer and slow down its growth.

SCALOP-2 aims to learn more about combining nelfinavir, capecitabine and radiotherapy, and to see which combination benefits patients most. Nelfinavir is an antiretroviral drug commonly used in the treatment of HIV. Research has shown that it can also boost the effects of radiotherapy. 

This is a two-part trial. Researchers have already completed stage 1 of this trial, which aimed to find out a safe dose of nelfinavir to give alongside chemoradiotherapy.

Researchers are now recruiting for the second stage of the trial. They will test whether increasing the dose of radiotherapy, adding nelfinavir, or a combination of the two will make the chemoradiotherapy more effective.

Who is the trial suitable for?

The SCALOP-2 trial may be suitable for you if you have:

• locally advanced, inoperable cancer that hasn’t spread to other parts of the body
• a tumour that measures 6 cm or less
• had another cancer that has been successfully treated, and has not come back in the last three years
• had tests that show you are fit encough to take part in this trial – the trial centre will provide information on this.

It is not suitable for you if you have:

• pancreatic cancer that can be removed by surgery (operable cancer)
• cancer that has spread from the pancreas to other parts of the body (advanced or metastatic pancreatic cancer)
• had other serious health conditions – speak to the trial team about this
• any other medical condition that might affect your safety during the trial
• had previous radiotherapy to your upper abdomen (tummy area)
• had previous pancreatic cancer that has come back after surgery.

There may be other reasons for not being able to take part in a trial. It is important to speak to your consultant about whether this trial might be suitable for you.

Recruitment start date for Stage 2: April 2017

Recruitment end date for Stage 2: October 2019

Published May 2016

Review date May 2018