Trial Outcomes & Findings for Neoadjuvant Chemoradiation for Resectable Glioblastoma (NCT NCT04209790)

NCT ID: NCT04209790

Last Updated: 2025-11-10

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

7 months for each patient from registration

Results posted on

2025-11-10

Participant Flow

Participant milestones

Participant milestones
Measure	Neoadjuvant Chemoradiation and Surgical Resection Neoadjuvant chemoradiation: 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. Drug Therapy with Temozolomide (benzolamide) (Standard of Care): 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. Surgery post Radiation and Temozolomide (benzolamide): Surgical resection of GBM will be done after radiation and Temozolomide treatment.
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Neoadjuvant Chemoradiation and Surgical Resection Neoadjuvant chemoradiation: 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. Drug Therapy with Temozolomide (benzolamide) (Standard of Care): 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. Surgery post Radiation and Temozolomide (benzolamide): Surgical resection of GBM will be done after radiation and Temozolomide treatment.
Overall Study Physician Decision	1

Baseline Characteristics

Neoadjuvant Chemoradiation for Resectable Glioblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neoadjuvant Chemoradiation and Surgical Resection n=2 Participants Neoadjuvant chemoradiation: 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. Drug Therapy with Temozolomide (benzolamide) (Standard of Care): 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. Surgery post Radiation and Temozolomide (benzolamide): Surgical resection of GBM will be done after radiation and Temozolomide treatment.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	56.5 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 months for each patient from registration

Outcome measures

Outcome measures
Measure	Neoadjuvant Chemoradiation and Surgical Resection n=2 Participants Neoadjuvant chemoradiation: 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. Drug Therapy with Temozolomide (benzolamide) (Standard of Care): 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. Surgery post Radiation and Temozolomide (benzolamide): Surgical resection of GBM will be done after radiation and Temozolomide treatment.
No Study Related Undue Toxicity or Progression	2 Participants

PRIMARY outcome

Timeframe: 7 months after completion of therapy

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.

Outcome measures

Outcome measures
Measure	Neoadjuvant Chemoradiation and Surgical Resection n=2 Participants Neoadjuvant chemoradiation: 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. Drug Therapy with Temozolomide (benzolamide) (Standard of Care): 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. Surgery post Radiation and Temozolomide (benzolamide): Surgical resection of GBM will be done after radiation and Temozolomide treatment.
Progression Free Survival	1 Participants

Adverse Events

Neoadjuvant Chemoradiation and Surgical Resection

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Neoadjuvant Chemoradiation and Surgical Resection n=2 participants at risk Neoadjuvant chemoradiation: 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. Drug Therapy with Temozolomide (benzolamide) (Standard of Care): 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. Surgery post Radiation and Temozolomide (benzolamide): Surgical resection of GBM will be done after radiation and Temozolomide treatment.
Blood and lymphatic system disorders Grade 1 Hemoglobin	50.0% 1/2 • Number of events 1 • Through study completion, an average of 2 years
Blood and lymphatic system disorders Grade 1 Dermatitis	50.0% 1/2 • Number of events 1 • Through study completion, an average of 2 years
Skin and subcutaneous tissue disorders Dermatitis	50.0% 1/2 • Number of events 1 • Through study completion, an average of 2 years
Blood and lymphatic system disorders Decrease in blood platelet count	100.0% 2/2 • Number of events 2 • Through study completion, an average of 2 years
Blood and lymphatic system disorders Grade 3 Lymphocyte decrease	50.0% 1/2 • Number of events 1 • Through study completion, an average of 2 years
General disorders Nausea	50.0% 1/2 • Number of events 1 • Through study completion, an average of 2 years
General disorders Fatigue	50.0% 1/2 • Number of events 1 • Through study completion, an average of 2 years
Blood and lymphatic system disorders Infection	50.0% 1/2 • Number of events 1 • Through study completion, an average of 2 years

Additional Information

Regulatory Project Manager

Geisinger

Phone: 570-214-2462

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place