MonoGerm

• Research type

  Research Study

• Full title

  MonoGerm: A phase II trial of carboplatin or vinblastine monotherapy induction prior to radiotherapy for patients with intracranial germinoma

• IRAS ID

  1009937

• Contact name

  Matthew Murray

• Contact email

  matthew.murray1@nhs.net

• Sponsor organisation

  University of Birmingham

• ISRCTN Number

  ISRCTN51537899

• Research summary

  MonoGerm is 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.
  We are trying to find out if germinomas respond to one-drug outpatient chemotherapy (‘monotherapy’) as well as three-drug chemotherapy, and does monotherapy cause fewer side-effects?
  As part of this trial, patients will receive up to 12 weeks of either carboplatin every 3-weeks (18 patients), or weekly vinblastine (18 patients). Disease response will be compared with the expected response to standard three-drug chemotherapy. After chemotherapy patients will receive radiotherapy as per current standard treatment.
  An early MRI scan after 6 weeks of treatment will be reviewed by experts and if disease response is not good enough, treatment will be switched to standard three-drug chemotherapy. The trial will be closely monitored against pre-agreed safety criteria and will be stopped if these are not met.
  We will also treat patients with metastatic disease as part of this trial. Currently, patients whose tumours have spread have radiotherapy to the whole brain and spine (no chemotherapy). Radiotherapy takes time to arrange, during which the tumour can grow. On this trial weekly vinblastine will be given, if delays are expected, to try and help shrink tumours to prevent complications. This treatment could potentially reduce the doses of radiotherapy required for these patients in the future.
  We hope that patients will have a better quality-of-life with fewer side effects, and will spend less time in hospital.

• REC name

  HSC REC A

• REC reference

  25/NI/0126

• Date of REC Opinion

  12 Nov 2025

• REC opinion

  Further Information Favourable Opinion