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

Spots Global Cancer Trial Database for first progression of glioblastoma