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Experimental Pre-Surgery treatment for brain cancer shows early hurdles

NCT ID NCT04209790

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

2 people

The number who actually took part.

Started

Apr 2020

Finished

Sep 2022

Lead sponsor

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

18 to 89 years

Sex

Anyone

Healthy volunteers

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

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

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • 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.