A trial of treatment for children and adults with rhabdomyosarcoma (FAR-RMS)

The trial team hope to find 1,250 children and adults to join this trial. 

The team are looking at:

• initial chemotherapy to get rid of sarcoma (induction treatment)
• radiotherapy 
• chemotherapy to get rid of any traces of cancer that are leftover from previous treatment or to keep the sarcoma under control for longer (maintenance treatment)
• adding regorafenib to chemotherapy for sarcoma that has come back

Your doctor will tell you about the treatment group you might be suitable to join. And how this treatment may differ from standard treatment . You may be able to join more than 1 part of the trial. 
         
The team tell you when you have treatment and for how long.

We have included a brief summary of each treatment group.

Dose finding group (for newly diagnosed RMS)
This part is for people whose cancer has spread to the lymph nodes or elsewhere in the body. This part of the trial is open to recruitment. 

Researchers think adding a drug called irinotecan to standard chemotherapy might improve treatment. A standard combination of chemotherapy includes the drugs ifosfamide, vincristine and actinomycin D (IVA).

Irinotecan is a chemotherapy drug which is already used to treat many different types of cancer. In this group you have irinotecan alongside IVA chemotherapy. 

The first few people have a low dose of irinotecan. If they don’t have any side effects the next few people have a higher dose and so on until they find the best dose. This is a dose finding study. 

When they find the best dose then the initial chemotherapy groups can open. These are groups CT1a and CT1b. 

Initial chemotherapy – very high risk group (CT1a)
This part of the trial opens when they find the best dose of irinotecan in the dose finding study. This part of the trial isn’t open yet. 

The team are looking at adding irinotecan to standard chemotherapy. A usual treatment for this group is a combination of chemotherapy called IVADo.

You are put into a treatment group at random. You have 1 of the following:

• ifosfamide, vincristine, actinomycin D and doxorubicin (IVADo) – standard treatment 
• irinotecan, ifosfamide, vincristine and actinomycin D (IRIVA) – new combination of treatment

The aim is to see which treatment works best. You have 9 cycles of chemotherapy .

Initial chemotherapy – high risk group (CT1b)
This part of the trial opens when they find the best dose of irinotecan in the dose finding study. This part of the trial isn’t open yet. 

The team are looking at adding irinotecan to standard chemotherapy. A standard treatment for this group is a combination of chemotherapy called IVA. 

You are put into a treatment group at random . You have 1 of the following:

• ifosfamide, vincristine, actinomycin D (IVA)
• irinotecan, ifosfamide, vincristine and actinomycin D (IRIVA)

The aim is to see which treatment works best. You have 9 cycles of  chemotherapy. 

Maintenance chemotherapy – very high risk group (CT2a)
This part of the trial is for people who are having maintenance chemotherapy that includes the drugs vinorelbine and cyclophosphamide. This part of the trial is open to recruitment. 

The team are looking at whether giving maintenance therapy for longer works better. 

Everyone has 12 cycles of chemotherapy as usual. This is standard for this group. You have the drugs vinorelbine and cyclophosphamide (VC). Towards the end of this treatment you are put into a treatment group at random. 

You:

• either stop maintenance chemotherapy or
• have 12 extra cycles of chemotherapy

Maintenance chemotherapy – high risk group (CT2b)
This part of the trial is for people who are having maintenance chemotherapy that includes the drugs vinorelbine and cyclophosphamide. This part of the trial is open to recruitment.

The team are looking at whether giving maintenance therapy for longer works better. 
Everyone has 6 cycles of chemotherapy as usual. This is standard for this group. Towards the end of this treatment you are put into a treatment group at random. You:

• either stop maintenance chemotherapy or
• have 6 extra cycles

    

Chemotherapy for sarcoma that has come back (CT3)
This part of the trial is for people whose sarcoma has come back (relapsed) after treatment. And they are now due to have more chemotherapy.

This part of the trial is open to recruitment.

The standard chemotherapy for relapsed sarcoma is a combination of three chemotherapy drugs. They are called vincristine, irinotecan and temozolomide (VIT). The trial team want to see if a newer combination of drugs works better. They think that replacing temozolomide with a drug called regorafenib will improve treatment. 

You are put into a treatment group at random. You have one of the following:

• vincristine, irinotecan and temozolomide (standard treatment)
• vincristine, irinotecan and regorafenib

You have up to 12 cycles of treatment.

Radiotherapy for sarcoma that can be removed by surgery (Groups RT1a and RT1b)
This part of the trial is for people who have already had chemotherapy as part of this trial or as part of their standard care.

This part of the trial is open to recruitment.

It is usual to have radiotherapy after surgery for sarcoma. The trial team want to see if radiotherapy before surgery works better. And if a higher dose works better than the standard dose. 

You are put into a treatment group at random. You have 1 of the following:

• radiotherapy before surgery
• radiotherapy after surgery

Some people have a higher risk of their sarcoma coming back. If this risk applies to you, you also enter a second randomisation. This determines the dose of chemotherapy you have. You have 1 of the following: 

• standard dose radiotherapy
• high dose radiotherapy 

Radiotherapy for sarcoma that can’t be removed by surgery (Group RT1c)
This part of the trial is for people who have already had chemotherapy as part of this trial or as part of their standard care. And whose cancer hasn’t spread elsewhere in the body.

This part of the trial is open to recruitment. 

You are put into a treatment group at random. You have 1 of the following:

• standard dose radiotherapy
• high dose radiotherapy

 
Radiotherapy for sarcoma that has spread elsewhere in the body (Group RT2)
This part of the trial is for people who have already had chemotherapy as part of this trial or as part of their standard care.

This part of the trial is open to recruitment. 

Cancer that has spread elsewhere in the body is called metastatic cancer. This part of the trial is looking at which sites in the body to give radiotherapy to.
You are put into a group at random. You have 1 of the following:

• radiotherapy to where the sarcoma started and lymph nodes with cancer cells in them
• radiotherapy to where the sarcoma started, lymph nodes with cancer cells and other areas of cancer spread in the body

The researchers want to find out which method of giving radiotherapy works best. 

Quality of life
For some groups the trial team ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.