Health TrialsbyHealthPanel

Tamoxifen Versus Etoposide After First Recurrence in GBM Patients

ConditionGlioblastoma Multiforme
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAHS Cancer Control Alberta

About this trial

The investigator propose a single-center randomized phase II controlled study designed to compare the management of first recurrence of GBM using etoposide versus tamoxifen.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically proven GBM with progression after previous first line chemoradiotherapy with temozolomide.

Progression documented by MRI with at least one bi-dimensionally measurable target lesion with one diameter of at least 10 mm, visible on two or more axial slices 5 mm apart.

Not received radiotherapy within the three months before the diagnosis of progression.

Stable or decreasing dose of corticosteroids prior to randomization: corticosteroids (dexamethasone) should be given at the lowest dose needed to control symptoms arising from increased intracerebral edema.

Disqualifiers

History of another malignancy or a concurrent malignancy (exceptions include patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ.

Uncontrolled hypertension (systolic blood pressure >150 mm Hg or diastolic blood pressure >100 mm Hg).

Any arterial or venous thrombosis up to 6 months before registration.

Evidence of recent hemorrhage on brain MRI.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tamoxifen

    Drug

    Tamoxifen 20 mg daily for 3 days then 20 mg BID for 3 days then increase by 20 mg daily every 3 days until 100 mg BID continuously

  • Etoposide

    Drug

    etoposide 50mg/m2 daily

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: EtoposideActive comparator 1 intervention
Group B: TamoxifenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

3 month progression-free survival

Time between randomization and radiographic or clinical progression leading to change in therapy for recurrent disease or death due to any cause.

Time frame
3 months

Secondary outcomes

1

One-year progression-free survival

Time between randomization and radiographic or clinical progression leading to change in therapy for recurrent disease or death due to any cause.

Time frame
12 months
2

Overall survival

Time between randomization and death due to any cause. Patients without an event will be censored the last time they were known to be alive.

Time frame
Median, 6-month, 1-year, and 2-year OS rates will be measured
3

Health-related quality-of-life status

Health-related quality-of-life will be assessed using the EORTC QLQ-BN20 brain tumor module questionnaire. This is a self-report questionnaire consisting of 20 items that assess future uncertainty, visual disorder, motor dysfunction, and communication deficit in brain tumor patients

Time frame
Throughout study completion, up to 5 years.
4

Adverse events

This includes fatigue, hematologic toxicities (neutropenia, thrombocytopenia, leukopenia, anemia), liver toxicities, hypertension, diarrhea, seizures and thrombosis and will all be recorded.

Time frame
Throughout the whole duration of the trial, up to 5 years

Other outcomes

Sponsors and contacts

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

AHS Cancer Control Alberta

Lead sponsor

Source ClinicalTrials.gov
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