STUPP Regimen With or Without Lenvatinib for Newly Diagnosed Glioblastoma With MGMT Promoter Methylation

ConditionsGlioma Glioblastoma (GBM)MGMT-Methylated Glioblastoma

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorDongguan People's Hospital

About this trial

To compare the efficacy and safety of Lenvatinib combined with the standard Stupp regimen versus the standard Stupp regimen alone in the treatment of newly diagnosed glioblastoma with MGMT promoter methylation positive.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed GBM confirmed by post-op pathology/biopsy, MGMT promoter methylation positive, no prior RT or chemo.

Surgery/biopsy ≤ 21 days before enrollment.

Age 18-75 years any gender.

KPS ≥ 70.

Disqualifiers

Allergy to Lenvatinib, TMZ, or components.

Other malignancies within 5 years or concurrent, or prior anti-tumor therapy.

Concurrent participation in another clinical trial (except observational).

Grade 4 non-hematological toxicity (except hair loss, nausea, vomiting).

Trial design

Design model

Parallel

Treatments tested in this trial

Lenvatinib
Drug
Chemotherapy:Lenvatinib-TMZ Group: During RT, TMZ 75 mg/m² po QD and Lenvatinib 20 mg po QD; 4 weeks after RT, 6 cycles of TMZ maintenance; Lenvatinib continues at 20 mg QD post-RT until progression or intolerable toxicity.
TMZ (Temozolomide)
Drug
Chemotherapy: TMZ Group: During RT, TMZ 75 mg/m² po QD; 4 weeks after RT, 6 cycles
radiotherapy
Radiation
Starts 2-6 weeks post-op; total dose 60 Gy (2.0 Gy/fraction, 30 fractions) over 6-7 weeks.

Treatment groups

138 Participants

are divided into 2 treatment groups

Group A: experimental group：Lenvatinib + TMZ + radiotherapyExperimental treatment 3 interventions

Group B: control group：TMZ + radiotherapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

Progression-Free Survival（PFS）

defined as the time from enrollment to the first documented local-regional recurrence, distant metastasis, or death from any cause

Time frame

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Secondary outcomes

Overall survival (OS)

defined as the time from enrollment to death from any cause.

Time frame

From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 36 months

Best Overall Response (BOR)

determined by modified RANO criteria for patients with incomplete tumor resection and documented postoperative residual tumor.

Time frame

36 months

Safety evaluation

Adverse events (AE) and serious adverse events (SAE) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE V5.0).

Time frame

During the concurrent chemoradiotherapy phase; Weekly during maintenance chemotherapy cycles 1-6 (the worst result within each cycle will be recorded); At the end of treatment or disease progression. whichever came first, assessed up to 36 months.

Function quality of Life

Aassessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 ( (EORTC QLQ-C30) : Scores are converted to 0-100 scale. Higher scores indicate better functioning and quality of life for functional and global health/QoL domains, while higher symptom scores indicate greater symptom burden.

Time frame

Before the concurrent chemoradiotherapy phase; Weekly before maintenance chemotherapy cycles 1-6 (the worst result within each cycle will be recorded); At the end of treatment or disease progression. whichever came first, assessed up to 36 months.

Other outcomes

Exploratory Endpoints (optional)

Evaluate tumor tissue biomarkers: Using tumor tissue specimens provided during the screening period, explore the correlation between TERT promoter mutation, 1p/19q deletion, BRAF V600E gene status, as well as the expression levels of Lenvatinib-related targets (e.g., VEGFR 1-3, FGFR 1-4, PDGFRα/β) with the PFS and OS of the subjects through next-generation sequencing (NGS) or immunohistochemistry (IHC) techniques.

Time frame

Before the first dose, after the completion of radiotherapy, and at the time of disease progression, whichever came first, assessed up to 36 months.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dongguan People's Hospital

Lead sponsor

Source ClinicalTrials.gov

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