RecruitingPhase IIInterventional

MonoGerm: A trial to test if using one chemotherapy drug is as good as using three chemotherapy drugs before radiotherapy for patients with germinoma brain tumours

The MonoGerm trial is for patients with a type of brain tumour called germinoma. We want to find out if using just one chemotherapy drug before radiotherapy works as well as the usual three-drug treatment. We're also checking if the one-drug treatment causes fewer side effects and helps patients feel better overall. Participants will receive either carboplatin or vinblastine for up to 12 weeks. We'll closely watch how the tumour responds with scans. If the one-drug treatment isn't working as expected, patients will switch to the standard three-drug chemotherapy. This trial aims to improve treatment with potentially less time in hospital and a better quality of life for patients.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

University of Birmingham

Enrolment target

Start

30 Jun 2025

Estimated completion

31 Jan 2030

Intracranial germinoma

What is this study about?

The MonoGerm trial is exploring new ways to treat a specific type of brain tumour called germinoma. Currently, people with germinomas usually receive three different chemotherapy drugs before having radiotherapy. This can be quite tough, with many side effects and a lot of time spent in the hospital.

This trial wants to see if we can get the same good results using just one chemotherapy drug instead of three. We're testing two different single drugs: carboplatin and vinblastine. Our main goal is to find out if these one-drug treatments are just as effective at shrinking the tumour, but also whether they cause fewer side effects and help patients have a better quality of life. If we can achieve similar results with less intensive treatment, it would be a big step forward for patients and their families.

For some patients whose tumour has spread (metastatic disease), the trial also aims to give a single chemotherapy drug (vinblastine) if there are delays in starting radiotherapy. This is to help control the tumour growth and potentially reduce the amount of radiotherapy needed later. We believe this could make the overall treatment process easier and more effective for these patients.

Key takeaways

Tests if one chemotherapy drug works as well as three for germinoma brain tumours.
Aims for fewer side effects and better quality of life.
Includes a safety scan to check response early on.
Patients switch to standard treatment if one drug isn't effective enough.
May offer vinblastine for metastatic disease to control growth.
It aims to reduce hospital visits and improve patient experience.

Who may be eligible?

This study is open to patients of any age who have been diagnosed with a germinoma brain tumour that is located in the brain and hasn't spread. Sometimes, if the tumour has spread, you might also be able to join.

For all patients, we'll need to check your blood and fluid around your brain and spine to make sure certain markers and your liver are working fine. If you can get pregnant, you'll need to use effective birth control during treatment and for six months after.

You also need to be willing to come to scheduled appointments and follow the study's plan. Before you can join, you'll need to give your written consent, meaning you agree to take part after understanding everything about the trial.

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.

Do I have a germinoma brain tumour confirmed by a doctor?
Has my doctor said my germinoma is only in my brain, or has spread?
Are my blood tests and liver function okay?
If I can get pregnant, am I able to use effective birth control during and after the trial?
Am I willing to attend all scheduled appointments for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the MonoGerm trial, you would receive either a single chemotherapy drug (carboplatin) every three weeks, or another single chemotherapy drug (vinblastine) every week. This treatment would last for up to 12 weeks. During this time, you'd have regular check-ups and a special scan (MRI) after about six weeks to see how the tumour is responding. If the scan shows the treatment isn't working as well as we’d expect, you would switch to the usual three-drug chemotherapy treatment.

After completing the chemotherapy part of the trial, you will then receive radiotherapy, which is the standard treatment. You may also be asked to complete some short questionnaires about your quality of life. We will also ask for some extra blood and, in some cases, extra fluid samples from around your brain and spine. These samples help researchers understand the drugs better. Wherever possible, these will be taken at the same time as your routine samples to minimise discomfort. The total duration of active treatment with chemotherapy is up to 12 weeks, followed by radiotherapy and then regular check-ups as part of your ongoing care.

Potential risks and benefits

The main benefit we hope for is a better quality of life for patients due to fewer side effects and less time spent in hospital, while still ensuring the treatment is effective against the tumour. The main risk is that the one-drug treatment might not be as effective as the standard three-drug treatment in some cases. However, we have a safety scan after six weeks to catch this early, and you would switch to the standard treatment if needed. Some patients might also have extra blood or fluid samples taken, or an additional lumbar puncture, though we aim to minimise discomfort. For those with metastatic disease, receiving chemotherapy before radiotherapy is a new step that carries potential side effects, but vinblastine is usually well-tolerated. Remember, you can choose to leave the study at any time, for any reason.

Locations (11)

Cambridge University Hospitals NHS Foundation Trust
City only
Cambridge, England
NHS Lothian
Approximate
Edinburgh, Scotland
University Hospitals Bristol and Weston NHS Foundation Trust
City only
Bristol, England
NHS Greater Glasgow and Clyde
City only
Glasgow, Scotland
Birmingham Women's and Children's NHS Foundation Trust
City only
Birmingham, England
The Royal Marsden Hospital (surrey)
City only
Sutton, England
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City only
Newcastle upon Tyne, England
Oxford University Hospitals NHS Foundation Trust
City only
Oxford, England
The Christie NHS Foundation Trust
City only
Manchester, England
University Hospitals Birmingham NHS Foundation Trust
City only
Birmingham, England
Leeds Teaching Hospitals NHS Trust
Unverified
Leeds, England

Common questions

What is a germinoma brain tumour?

It's a specific type of rare brain tumour that affects the brain.

What does 'monotherapy' mean?

It means using just one drug for treatment, rather than a combination of several drugs.

What happens if the one-drug chemotherapy isn't working?

You'll have a scan after six weeks, and if the tumour isn't responding well, you'll switch to the standard three-drug chemotherapy.

Will I still receive radiotherapy?

Yes, after the chemotherapy part of the trial, you will still receive radiotherapy, which is a standard treatment for germinomas.

Who is paying for this study?

The study is funded by the Little Princess Trust and the Children's Cancer Leukaemia Group (CCLG).

How to find out more

. Study Team

monogerm@trials.bham.ac.uk +44 121 4147851 Official trial record

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