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Tamoxifen Versus Etoposide After First Recurrence in GBM Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04765098
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : April 6, 2022
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: Tamoxifen Drug: Etoposide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Tamoxifen Versus Etoposide for Patients With First Recurrence of Glioblastoma Multiforme
Actual Study Start Date : January 28, 2022
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : December 2026

Arm Intervention/treatment
Active Comparator: Etoposide Drug: Etoposide
etoposide 50mg/m2 daily

Experimental: Tamoxifen Drug: Tamoxifen
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

Primary Outcome Measures :
  1. 3 month progression-free survival [ Time Frame: 3 months ]
    Time between randomization and radiographic or clinical progression leading to change in therapy for recurrent disease or death due to any cause.

Secondary Outcome Measures :
  1. One-year progression-free survival [ Time Frame: 12 months ]
    Time between randomization and radiographic or clinical progression leading to change in therapy for recurrent disease or death due to any cause.

  2. Overall survival [ Time Frame: Median, 6-month, 1-year, and 2-year OS rates will be measured ]
    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.

  3. Health-related quality-of-life status [ Time Frame: Throughout study completion, up to 5 years. ]
    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

  4. Adverse events [ Time Frame: Throughout the whole duration of the trial, up to 5 years ]
    This includes fatigue, hematologic toxicities (neutropenia, thrombocytopenia, leukopenia, anemia), liver toxicities, hypertension, diarrhea, seizures and thrombosis and will all be recorded.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically proven GBM with progression after previous first line chemoradiotherapy with temozolomide.
  2. 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.
  3. Not received radiotherapy within the three months before the diagnosis of progression.
  4. 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.
  5. ECOG performance 0-2 (Appendix 2).
  6. Age from 18-65 years.
  7. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes.
  8. Patients of childbearing / reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period and for a period of 60 days after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.

    Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.

  9. Laboratory evaluation obtained within 7 days prior to randomization, with adequate function as defined below:

    • ANC ≥ 1.5 x 109/L
    • Platelets ≥ 100 x 109/L
    • Serum creatinine ≤ 1.5 times ULN
    • Total serum bilirubin ≤ 1.5 times ULN
    • ALT < 3 times ULN
    • AST < 3 times ULN
    • Alkaline phosphatase < 3 times ULN
  10. Patient must understand and sign an informed consent prior to study registration.

Exclusion Criteria:

  1. 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.
  2. Uncontrolled hypertension (systolic blood pressure >150 mm Hg or diastolic blood pressure >100 mm Hg).
  3. Any arterial or venous thrombosis up to 6 months before registration.
  4. Evidence of recent hemorrhage on brain MRI.
  5. Substantial cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (> New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04765098

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Contact: Jacob Easaw, MD, PhD, FRCPC 780-432-8290

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Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada
Sponsors and Collaborators
AHS Cancer Control Alberta
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Responsible Party: AHS Cancer Control Alberta Identifier: NCT04765098    
Other Study ID Numbers: IIT-0014
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Disease Attributes
Pathologic Processes
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents