Neoplasms

All Conditions

Symptoms and General Pathology

Rare Diseases

Glioblastoma

Disease Progression

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Disease Attributes

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Lomustine

Antineoplastic Agents, Alkylating

Alkylating Agents

Given at least 6 months after the end of prior radiotherapy

Reirradiation

EORTC

Meinhard Nevinny-Stickel, Univ. Prof. Dr. med.

Josef Pichler, MD

Matthias Preusser, Univ. Prof. Dr.

Clemens Seidel, PD Dr. Med.

Seidel Clemens, PD Dr. Med.

Ghazaleh Tabatabai, Prof. Dr. Med. Dr.

Matthijs Van der Meulen

Marjolein Geurts, Prof.

Matthias Preusser, Prof.

Giuseppe Minniti, Dr.

Despite comprehensive multimodal treatment of newly diagnosed glioblastoma, almost all patients suffer from tumour relapse. Currently, no standard of care exists to treat these tumour relapses. Treatment options include repeated surgery (if feasible), systemic therapy (bevacizumab, lomustine, temozolomide re-challenge), reirradiation and best supportive care. Currently, the superiority of combined chemoradiation versus chemotherapy alone remains unproven. Given that lomustine is the standard chemotherapeutic agent for the treatment of recurrent glioblastoma in Europe and the unclear efficacy of reirradiation, we want to explore whether combining lomustine and reirradiation may be a better treatment than lomustine alone. The results of the prospective randomized trial proposed here should demonstrate a significant improvement in overall survival when lomustine is combined with reirradiation in patients with recurrent glioblastoma compared to lomustine alone without adversely affecting quality of survival. The trial will be stopped based on overall survival in a preplanned futility and efficacy interim analysis.

Lomustine With and Without Reirradiation for First Progression of Glioblastoma: a Randomized Phase III Study

Changes in HRQoL from baseline in the GHQ/QoL, fatigue, nausea/vomiting, physical, role and social functioning scale scores assessed over time will be evaluated descriptively. Descriptive summaries such as median, range (minimum, maximum), IQR, mean and standard deviation will be provided for all the other scales from the QLQ-C30, QLQ-BN20 and the item list (IL46).

For functional and global HRQoL scales, higher scores represent a better level of functioning and are converted to a 0 to 100 scale. For symptom-oriented scales, a higher score represents more severe symptoms.

Defined as the number of days from date of enrolment to the date of death due to any cause

Events are progressions based on Response Assessment in Neuro Oncology (RANO) criteria as determined by the local investigator .

HRQoL will be assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3.

Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0 for toxicity and Serious Adverse Event reporting.

Neurocognitive functioning assessed by Mini Mental State Examination (MMSE)

A deterioration event is defined as ≥\>10-point worsening from baseline in the GHQ without further improvement (i.e., no subsequent ≥\>10 point improvement) or death due to any cause.

European Organisation for Research and Treatment of Cancer - EORTC

Blood and Lymph Conditions

Thrombocytopenia

Blood Platelet Disorders

Hematologic Diseases

Cytopenia

Subcutaneous administration of Romiplostim

Romiplostim

Emilie Le Rhun

Romiplostim for low platelets caused by lomustine chemotherapy in patients with first recurrence (growing back) of a brain tumor, glioblastoma that is MGMT methylated.

Lomustine is an anticancer drug often used to treat glioblastoma that grows back after initial treatment. This anticancer drug can cause side effects. The most frequent and potentially serious side effect of all is lowering of the blood platelets. Low platelets can cause bleedings in the the stomach and intestines, the skin, the brain and other systems and tissues.

Low platelets are also the main cause of delaying or prematurely (ending treatment before the planned end) stopping chemotherapy. There is no treatment for low platelets except platelet transfusions. Romiplostim is a drug that stimulates the production of platelets in the bone marrow. It is an approved drug in USA, Europe, Australia and Switzerland for a special type of blood disease in which the body breaks down its own blood platelets.

The purpose of the study is to start the treatment with romiplostim once low platelets are diagnosed in order to restore the platelet count and to prevent the platelet count from dropping again during the lomustine treatment.

Phase II Trial of Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-meth Glioblastoma

Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-methylated Glioblastoma: a Randomized Phase II Open Label Multicenter Study

This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, for adverse event reporting.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Lomustine With and Without Reirradiation for First Progression of Glioblastoma: a Randomized Phase III Study	NCT05904119	First Progressi...	Lomustine Reirradiation	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Phase II Trial of Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-meth Glioblastoma	NCT04933942	First Progressi...	Lomustine Romiplostim	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC

Spots Global Cancer Trial Database for first progression