A trial looking at two surgical treatments for early mouth cancer (SEND-001)

Cancer type:

Head and neck cancers

Mouth (oral) cancer

Status:

Results

Phase:

Phase 4

This trial compared two standard surgical treatments for mouth cancer, to see if one approach had a better outcome.

This was open for people to join between 2007 and 2015. These results were published in 2019.

Cancer Research UK supported the trial. For other funders see below.

More about this trial

Mouth cancer can sometimes spread to other parts of your body. The first place is usually the lymph glands in your neck on the same side as the mouth cancer. Doctors know that some people with early cancers in the mouth can have tiny cancers (secondaries) that have already spread to their neck lymph glands. But often the surgeons can’t see or feel these tiny cancers and they don’t show up on scans.

When you have your cancer removed the surgeon would also remove the glands if they know for certain they have cancer in them. This is called a neck dissection. But they can decide to remove the glands in the neck even if they can’t be certain there is cancer in them. This is called a Selective Elective Neck Dissection (SEND).

Because surgeons can’t tell when you have the tiny hidden secondaries, they might do the SEND procedure when your mouth cancer is removed. Or they may wait and only operate again if and when secondaries do develop. This research study was designed to help surgeons find out if one of these approaches was better than the other for their patients.

The aims of this trial were to find out:

If having SEND when the mouth cancer is removed increases the chances of the cancer never coming back
If having SEND when the mouth cancer is removed causes unnecessary physical harm or emotional harm and uses up more NHS time and other resources

Summary of results

Removing the lymph glands at the same time as the mouth cancer when there is no evidence that the cancer has spread to the glands increased the cure rate.

About this trial
596 people in 28 UK hospitals joined the trial.

For 230 people who had no signs of cancer in their neck glands neither they nor their doctor chose which type of surgery they had. They were put into 1 of the 2 groups at random. These were the randomised patients.

114 had their cancer and lymph glands removed.
116 had only their cancer removed.

Diagram 1

Also, as part of the study, 346 people chose which type of surgery they had with their surgeon. These patients were not randomised.

112 people had their cancer and lymph glands removed.
234 people had only their cancer removed.

Results
The researchers found that the results of the randomised patients were similar to those from the patients who had not been randomised. This strengthens the evidence and recommendations from this project.

In this summary we are providing the results for only the randomised patients.

The average follow up was just under 5 years (57 months).

The team looked at how many people were alive at 5 years after treatment. They found it was:

77 people out of every 100 (77.5%) who had their cancer and lymph glands removed
65 people out of every 100 (65.6%) who had only their cancer removed

This shows that people who have their cancer and lymph glands removed at the same time are more likely to be alive at 5 years after treatment than people who have only their cancer removed.

Graph 1

At 5 years after treatment they looked at the number of people who had no sign of their cancer coming back. They found it was:

64 people out of every 100 people (64.4%) who had their cancer and lymph glands removed
50 people out of every 100 (50.9%) who had only their cancer removed

This shows that people who have their cancer and lymph glands removed at the same time are more likely to stay alive and free of cancer than people who have only their cancer removed.

Graph 2

Quality of life
The quality of life Open a glossary item reported by both groups was similar overall.

Where it was statistically significant Open a glossary item the differences were:

people who had their cancer and lymph glands removed were more likely to experience a dry mouth compared to people who had only their cancer removed
people who had their cancer and lymph glands removed were less likely to feel nauseous compared to people who had only their cancer removed

Complications from surgery
People who had their cancer and lymph glands removed reported more complications. But the majority were not severe.

There was no major difference in the number of severe side effects reported by both groups.

The most common side effects reported by both groups were:

problems with the nerves in the neck causing a decrease in feeling and movement
swallowing problems

However these side effects were short lived and disappeared in most people.

Time in hospital
The researchers compared the average number of days in hospital after surgery. They found it was:

6 days for those who had their cancer and lymph glands removed
2 days for those who had only their cancer removed

Up to 2 years after the surgery the average number of days people were in hospital were:

4½ days for those who had their cancer and lymph glands removed
3 days for those who had only their cancer removed

The team also found there wasn’t much difference between the groups in the number of:

clinic (outpatient) appointments
GP visits

Conclusion
The team conclude these results provide clear evidence about the benefits and impact of surgery to remove the cancer and lymph glands in the same operation, even with the smallest mouth cancers.

They say this should remove the uncertainty in national guidelines about removing the cancer and lymph glands at the same time. They also provide measurable evidence between the 2 groups comparing:

quality of life
hospital stays
outpatient and GP visits
complications after surgery

All this information can help patients take a more active part in the decisions regarding their treatment.

The surgeons collected blood samples and samples of cancer tissue. They plan to do laboratory research to see if they can find factors in the samples such as genes that might tell them who would need SEND and who wouldn’t.

Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.