Experimental Pre-Surgery treatment for brain cancer shows early hurdles
NCT ID NCT04209790
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether giving chemotherapy and radiation before surgery could help control glioblastoma, a fast-growing brain tumor. Only 2 people enrolled before the study was stopped. The goal was to see if this approach was safe and could delay tumor regrowth.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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2 people
The number who actually took part.
- Started
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Apr 2020
- Finished
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Sep 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 89 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Newly diagnosed GBM with histopathological confirmation. 2. Surgically suitable for subtotal or gross total resection as determined by central review. 3. Karnofsky Performance Status (KPS)\>70 4. No contraindication for chemoradiation. 5. Complete blood count (CBC)/differential obtained within 28 days prior to registration, with adequate bone marrow function defined as follows: 1. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; 2. Platelets ≥ 100,000 cells/mm3; 3. Hemoglobin ≥ 8.0 g/dl (Note: the use of transfusion or other intervention to achieve Hgb ≥8.0 g/dl is acceptable) 6. Adequate hepatic function within 28 days prior to registration, as defined below: 1. Alanine Aminotransferase (ALT) and Aspartate transaminase (AST) ≤ 3 x ULN 2. Bilirubin ≤ 1.5 upper limit of normal (ULN) 7. Negative serum pregnancy test obtained for females of child-bearing potential within 28 days prior to step 2 registration. 8. Ability to get multiplanar contrast enhanced Magnetic Resonance Imaging (MRI) Exclusion Criteria: 1. Recurrent, unresectable or multifocal malignant gliomas. 2. Any site of distant disease (for example, drop metastases from the GBM tumor site) 3. Prior radiation or chemotherapy or radiosensitizers for cancers of the brain and head and neck region; note that prior chemotherapy for a different cancer is allowable (except temozolomide). 4. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. 5. Patents treated on any other therapeutic clinical protocols within 30 days prior to registration. 6. Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker, or severe claustrophobia). 7. Severe, active co-morbidity, defined as follows: 1. Transmural myocardial infarction within the last 6 months prior to registration 2. History of recent myocardial infarction 1month prior 3. New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 3 months prior to registration. 4. Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for surgical resection 5. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 6. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol. 7. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration 8. Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is because the treatments involved in this protocol may be significantly immunosuppressive with potentially fatal outcomes in patients already immunosuppressed. 9. Any other severe immuno-compromised condition. 10. Active connective tissue disorders, such as lupus or scleroderma that in the opinion of the treating physician may put the patient at high risk for radiation toxicity. 11. End-stage renal disease (i.e. on dialysis or dialysis has been recommended). 12. Any other major medical illnesses or psychiatric treatments that in the investigator's opinion will prevent administration or completion of protocol therapy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
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Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
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Other studies related to the condition(s) this trial covers.
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