A Phase 2 interventional study of Neoadjuvant chemoradiation and Drug Therapy with Temozolomide (benzolamide) (Standard of Care) in Glioblastoma, Surgery and High Grade Glioma, sponsored by Geisinger Clinic. Terminated at 2 sites in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-11-10.
Sponsored by Geisinger Clinic · Phase 2, Interventional, and Treatment
Preoperative therapy has not been well studied in resectable glioblastoma. This study attempts to prospectively assess the feasibility and efficacy of preoperative chemo radiation in improving local control, as this is the predominant mode of failure in these patients leading to poor outcomes.
This Phase II study design would be used to proceed with the study treatment after meeting pre-specified events in the initial phase, with goal being to determine whether the new treatment paradigm is sufficiently promising to warrant a major controlled clinical evaluation against the standard therapy.
Neo adjuvant, preoperative chemo radiation has consistently shown improvements in local disease control or organ preservation in many cancers including head and neck, esophageal, rectal, bladder cancers and sarcomas, leading to improvements in overall survival and limb or organ preservation.
This interventional study will be done in two phases using the Simon two-stage Phase II study design. The median progression-free survival of these patients with current standard of care therapy is in the range of 6-8 months (6.9 months in the standard of care). With the proposed trial of surgical resection of the tumor after chemotherapy and radiation the median progression free survival is anticipated to be approximately 11-12 months from subset analysis of available literature and based on prior data on other disease sites. In other words, the 7-month local progression rates is anticipated to decrease from 50% to 25%, or progression free survival improve from 50-75%
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 2 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Geisinger Clinic is the lead sponsor of 125 studies on the registry; 21 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Complete blood count (CBC)/differential obtained within 28 days prior to registration, with adequate bone marrow function defined as follows:
Adequate hepatic function within 28 days prior to registration, as defined below:
Exclusion Criteria:
Severe, active co-morbidity, defined as follows:
The experimental part of the study would be this selection of resectable patients and sequencing neoadjuvant chemoradiation prior to surgery.
Radiation: Neoadjuvant chemoradiation · Drug: Drug Therapy with Temozolomide (benzolamide) (Standard of Care) · Procedure: Surgery post Radiation and Temozolomide (benzolamide)
Intensity modulation radiation therapy (IMRT) with a simultaneous integrated boost with Fixed-gantry IMRT, helical tomotherapy, or Vesicular Modulated Arc Therapy (VMAT) can be used. All photon treatments shall be delivered with megavoltage machines of a minimum energy of 6 Megavolt (MV) photons. Selection of the appropriate photon energy(ies) should be based on optimizing the radiation dose distribution within the target volume and minimizing dose to non-target normal tissue.
Also known as: Standard adjuvant therapy
During Concomitant Radiation Therapy on the same day as the first fraction of radiotherapy. Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2 for a maximum of 49 days. The drug will be administered orally daily during radiotherapy, as best tolerated by the patient. During weekends without radiotherapy (Saturday and Sunday), the drug will be taken in the morning. The dose will be determined using actual body surface area (BSA) as calculated in square meters at the beginning of the concomitant treatment. The BSA will be calculated from the height obtained at the pretreatment visit. Capsules of temozolomide are available in 5, 20, 100, 140, 180, and 250 mg. The daily dose will be rounded to the nearest 5 mg.
Also known as: Neoadjuvant therapy
Surgical resection of GBM will be done after radiation and Temozolomide treatment.
No Study Related Undue Toxicity or Progression
Number of participants with no study related undue toxicity or progression within the limits of stage one patients. Toxicity is defined as: progression precluding surgery, unanticipated neurological decompensation, non-completion of neoadjuvant therapy (other than protocol defined dose adjustments or discontinuation), treatment related delay of \>6 weeks to surgery, and/or major unforeseen surgical complication requiring repeat surgical intervention including other than non-life-threatening infection like meningitis/encephalitis or septicemia.
Time frame: 7 months for each patient from registration
Progression Free Survival
Number of participants with Progression Free Survival/clinical progression with new or worsening neurological symptoms related to the tumor and not due to non-tumor or study related symptoms.
Time frame: 7 months after completion of therapy
| Milestone | Neoadjuvant Chemoradiation and Surgical Resection |
|---|---|
| Started | 2 |
| Completed | 1 |
| Not completed | 1 |
| Withdrew: Physician decision | 1 |
Number of participants with no study related undue toxicity or progression within the limits of stage one patients. Toxicity is defined as: progression precluding surgery, unanticipated neurological decompensation, non-completion of neoadjuvant therapy (other than protocol defined dose adjustments or discontinuation), treatment related delay of \>6 weeks to surgery, and/or major unforeseen surgical complication requiring repeat surgical intervention including other than non-life-threatening infection like meningitis/encephalitis or septicemia.
| Participants | Neoadjuvant Chemoradiation and Surgical Resection |
|---|---|
| No Study Related Undue Toxicity or Progression | 2 |
Number of participants with Progression Free Survival/clinical progression with new or worsening neurological symptoms related to the tumor and not due to non-tumor or study related symptoms.
| Participants | Neoadjuvant Chemoradiation and Surgical Resection |
|---|---|
| Progression Free Survival | 1 |
Collected over Through study completion, an average of 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Neoadjuvant Chemoradiation and Surgical Resection | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Event | Neoadjuvant Chemoradiation and Surgical Resection |
|---|---|
| Decrease in blood platelet countBlood and lymphatic system disorders | 2/2 |
| Grade 1 HemoglobinBlood and lymphatic system disorders | 1/2 |
| Grade 1 DermatitisBlood and lymphatic system disorders | 1/2 |
| DermatitisSkin and subcutaneous tissue disorders | 1/2 |
| Grade 3 Lymphocyte decreaseBlood and lymphatic system disorders | 1/2 |
| NauseaGeneral disorders | 1/2 |
| FatigueGeneral disorders | 1/2 |
| InfectionBlood and lymphatic system disorders | 1/2 |
| Age, Categorical(Participants) | Neoadjuvant Chemoradiation and Surgical Resection |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 0 |
| Age, Continuous(years) | Neoadjuvant Chemoradiation and Surgical Resection |
|---|---|
| Mean | 56.5 ± 7.5 |
| Sex: Female, Male(Participants) | Neoadjuvant Chemoradiation and Surgical Resection |
|---|---|
| Female | 1 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | Neoadjuvant Chemoradiation and Surgical Resection |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Neoadjuvant Chemoradiation and Surgical Resection |
|---|---|
| United States | 2 |
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