GlioblastomaPhase 1/2Tx-TreatmentNCT01120639
Phase 1-2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform
A Phase 1/2 study testing Temozolomide and Stereotactic Radiosurgery (SRS) in people with Glioblastoma and Cancer of Brain and Nervous System, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy plus the FDA-approved chemotherapy drug temozolomide Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Cancer of Brain and Nervous System, Glioblastoma Multiforme
- What is being tested?
- Temozolomide and Stereotactic Radiosurgery (SRS)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to 15 Nov 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed newly diagnosed glioblastoma multiforme. Diagnosis must be made by surgical biopsy or excision
- The tumor must be supratentorial in location
- The planning target volume (tumor plus margin) must measure ≤ 150 cm^3 in volume
- Age ≥ 18 years
- Life expectancy of at least 12 weeks
- Patient must have adequate organ function to tolerate temozolomide (details in the protocol)
Who cannot join
- Patients who have previously been treated with brain irradiation to the region that would result in overlap of the radiation fields
- Tumor foci detected below the tentorium
- Multifocal disease or leptomeningeal spread
- Prior allergic reaction to the study drugs involved in this protocol
- Patients with pacemaker will be allowed to undergo CT instead of MRI
- Pediatric patients (age < 18), pregnant women, and nursing patients will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase 1-2 Trial of Temozolomide and Hypofractionated Radiotherapy in Treatment of Supratentorial Glioblastoma Multiforme
The purpose of this study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy plus the FDA-approved chemotherapy drug temozolomide
Read the detailed description
Primary Objective: To determine the maximum tolerated dose (MTD), based on acute CNS toxicity at 30 days, of hypofractionated radiotherapy given in 5 fractions with temozolomide for the treatment of glioblastoma multiforme.
Secondary Objectives:
- Assess the short- and long-term adverse effects.
- Determine the radiographic response rate.
- Determine the overall survival rate.
- Assess quality of life during treatment
To determine the maximum tolerated dose (MTD) of hypofractionated (5 fractions) radiotherapy with temozolomide for the treatment of glioblastoma multiforme, patients will be evaluated by a multi-disciplinary team composed of radiation oncologists, neurosurgeons, and neuro-oncologists to assess for their eligibility. Patient's oncologic history, presenting symptoms, physical examination, pathology, and imaging studies will be reviewed. Patients will be evaluated for surgical candidacy and resectability. Patients who are surgical candidates will undergo a surgical resection prior to radiotherapy. Patients whose tumors are unresectable or are not good surgical candidates will undergo a biopsy for tissue diagnosis. Radiation will be delivered in five fractions.
- Being tested
- Temozolomide, Stereotactic Radiosurgery (SRS)
- Medical subject headings
- Glioblastoma, Brain Neoplasms, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodar, Temodal
75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
Stereotactic Radiosurgery (SRS)Procedure or surgery
Also called Hypofractionated stereotactic radiosurgery (h-SRS), Hypofractionated stereotactic radiotherapy, Cyberknife surgery
Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Radiosurgery (25 Gray x 5 fractions)+Temozolomide | Experimental | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Receives: Drug: Temozolomide; Procedure: Stereotactic Radiosurgery (SRS) |
| Stereotactic Radiosurgery (30 Gray x 5 fractions)+Temozolomide | Experimental | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Receives: Drug: Temozolomide; Procedure: Stereotactic Radiosurgery (SRS) |
| Stereotactic Radiosurgery (35 Gray x 5 fractions)+Temozolomide | Experimental | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Receives: Drug: Temozolomide; Procedure: Stereotactic Radiosurgery (SRS) |
| Stereotactic Radiosurgery (40 Gray x 5 fractions)+Temozolomide | Experimental | Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. Receives: Drug: Temozolomide; Procedure: Stereotactic Radiosurgery (SRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Dose-limiting Toxicities (DLTs)
The maximum-tolerated dose (MTD) of study treatment (temozolomid plus hypofractionated radiotherapy administered as 5 fractions) is defined as either:
- The highest radiation dose per protocol, or
- The radiation dose at which dose-limiting toxicities (DLTs) occurred in ≥ 2 of 3 participants at a dose level, and/or ≥ 2 of 6 participants, at a dose level.
Dose-limiting toxicity (DLT) was defined as a treatment-related (with possible, probable or definite attribution) Grade 3 to 5 CNS toxicity [Common Terminology Criteria for Adverse Events (CTCAE) v4] occurring within 30 days of stereotactic radiosurgery (SRS).
The non-stratified outcome is reported as the number of DLTs observed in by radiation dose and by strata (Planning Target Volume (PTV) < 60 cm³ and from 60 to 150 cm³).
Measured: 30 days
Secondary outcomes (9)
Number of Acute Toxicity Within 30 Days
Acute toxicity is defined as treatment-related adverse events that occur within 30 days of receiving radiotherapy. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 is used to grade adverse events. The non-stratified outcome is reported as number of treatment-related adverse events observed for each radiotherapy dose level.
Acute toxicity is based on radiotherapy dose level not tumor volume, and is reported by radiotherapy dose level only.
Measured: 30 days
Long-term Toxicity After More Than 30 Days
Long-term toxicity is defined as treatment-related adverse events (any grade or any Body System) that occur ≥ 30 days after receiving radiotherapy. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 is used to grade adverse events. The non-stratified outcome is reported as number of treatment-related adverse events observed for each dose level.
Long-term toxicity is based on radiotherapy dose level not tumor volume, and is reported by radiotherapy dose level only.
Measured: 12 months
Percent of Participants With Radiographic Response
Radiographic response rate was assessed following radiotherapy until disease progression. Response is considered to be the sum and proportion participants that achieved a complete response (CR); partial response (PR); or minor response (MR). The outcome is expressed as a number without dispersion for each cohort.
CR: Tumor is no longer detected by computed tomography (CT) or magnetic resonance imaging (MRI).
PR: Decrease in the product of the two greatest diameters > 50%, as determined by CT or MRI, with no new lesions, and the same or lower dose of dexamethasone.
MR: Decrease in the product of the two greatest diameters < 50%, as determined by CT or MRI, and neither PR nor PD.
PD: New tumor lesion, or > 25% increase in the product of the two greatest diameters of target lesion, as determined by CT or MRI, provided that within 2 months of completion of radiotherapy, the participant has not had a decrease in steroid dose since the last evaluation.
Measured: 6 months
Progression-free Survival
Progression-free survival (PFS) following radiotherapy, measured in months. Progressive disease (PD) is defined as: New tumor lesion, or > 25% increase in the product of the 2 greatest diameters of target lesion, as determined by computed tomography (CT) or magnetic resonance imaging (MRI), provided that within 2 months of completion of radiotherapy, the participant has not had a decrease in steroid dose since the last evaluation. The outcome is expressed as the median with 95% confidence interval for each cohort.
Measured: 18 Months.
Overall Survival (OS)
Overall survival (OS) was assessed as those participants remaining alive with any tumor status following radiotherapy after 20 months. The outcome is stratified by Planning Target Volume (PTV) < 60 cm³ or 60 to 150 cm³, and expressed as the median value with 95% confidence interval.
Measured: 20 Months.
Quality of Life by European Organisation for Research and Treatment of Cancer (EORTC-QLQ C30) Survey
European Organization for Research and Treatment of Cancer (EORTC-QLQ C30) quality of life surveys were administered at study entry and 12 months after treatment initiation to assess health-related quality of life (HR-QOL). The EORTC-QLQ C30 survey has 30 questions and responses are on scale of 1 to 4 with 1 indicating "not at all" and 4 indicating "very much". The total score can range from 30 to 120. The outcome is stratified by Planning Target Volume (PTV) < 60 cm³ or 60 to 150 cm³, and is expressed as the mean of the difference from baseline to 12 months, with 95% confidence interval.
Measured: 12 Months
Quality of Life by Brain-20 Survey
Brain-20 (BN-20) quality of life surveys were administered at study entry and 12 months after treatment initiation to assess health-related quality of life (HR-QOL). The Brain-20 (BN-20) quality of life survey has 20 questions and responses are on scale of 1 to 4 with 1 indicating "not at all" (most favorable) and 4 indicating "very much" (least favorable). The total score can range from 20 to 80, and the result is expressed as the difference from baseline (study entry) to 12 months after the start of treatment. The outcome is stratified by Planning Target Volume (PTV) < 60 cm³ or 60 to 150 cm³, and expressed as the mean with 95% confidence interval.
Measured: 12 months
Quality of Life by MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Survey
MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) quality of life surveys were administered at study entry and 12 months after treatment initiation to assess health-related quality of life (HR-QOL). MDASI-BT quality of life survey has 23 questions and responses are on scale of 0 to 10 with 0 indicating "did not interfere" (most favorable) and 10 indicating "interfered completely" (least favorable). A participant's overall score is computed as the mean of that participant's individual scores, and can range 0 to 10. The outcome is stratified by Planning Target Volume (PTV) < 60 cm³ or 60 to 150 cm³, and expressed as the mean difference from baseline with 95% confidence interval. A positive value for the mean indicates worsening quality of life.
Measured: 12 months
Treatment Failure Analysis
Treatment failure in individual participants, ie, tumor recurrence or metastasis, can be described by the location relative to the first treatment failure (ie, infield, marginal, or distal), as further defined below.
Failure pattern is defined as tumor recurrence or metastasis relative to the primary lesion that is
- Infield: at tumor or within 5 mm
- Marginal: > 5 mm or ≤ 20 mm from tumor
- Distal: > 20 mm from tumor
The outcome will be reported as the number of participants who failed treatment for each type of failure, ie, infield, marginal, or distal failure.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2016
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose-escalation with 2-level stratification
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Soltys, Stanford University
- Investigators
- Scott Gerard Soltys, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120639
- Sponsor's protocol ID
- IRB-17774
- Other IDs
- SU-04202010-5726, BRN0012, IRB-17774
- Acronym
- Tx-Treatment
- Status last verified
- Aug 2021
- First submitted
- 7 May 2010
- Last updated
- 6 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1-2 Trial of Temozolomide and Hypofractionated Radiotherapy in Treatment of Supratentorial Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT01120639
- Acronym / sponsor ID
- Tx-Treatment / IRB-17774
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Nov 2016 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 11 May 2010 (estimated)
- Results
- Posted 31 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy plus the FDA-approved chemotherapy drug temozolomide
Detailed description
Primary Objective: To determine the maximum tolerated dose (MTD), based on acute CNS toxicity at 30 days, of hypofractionated radiotherapy given in 5 fractions with temozolomide for the treatment of glioblastoma multiforme.
Secondary Objectives:
- Assess the short- and long-term adverse effects.
- Determine the radiographic response rate.
- Determine the overall survival rate.
- Assess quality of life during treatment
To determine the maximum tolerated dose (MTD) of hypofractionated (5 fractions) radiotherapy with temozolomide for the treatment of glioblastoma multiforme, patients will be evaluated by a multi-disciplinary team composed of radiation oncologists, neurosurgeons, and neuro-oncologists to assess for their eligibility. Patient's oncologic history, presenting symptoms, physical examination, pathology, and imaging studies will be reviewed. Patients will be evaluated for surgical candidacy and resectability. Patients who are surgical candidates will undergo a surgical resection prior to radiotherapy. Patients whose tumors are unresectable or are not good surgical candidates will undergo a biopsy for tissue diagnosis. Radiation will be delivered in five fractions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Dose-escalation with 2-level stratification
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Radiosurgery (25 Gray x 5 fractions)+Temozolomide | Experimental | Drug: Temozolomide, Procedure: Stereotactic Radiosurgery (SRS)Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. |
| Stereotactic Radiosurgery (30 Gray x 5 fractions)+Temozolomide | Experimental | Drug: Temozolomide, Procedure: Stereotactic Radiosurgery (SRS)Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. |
| Stereotactic Radiosurgery (35 Gray x 5 fractions)+Temozolomide | Experimental | Drug: Temozolomide, Procedure: Stereotactic Radiosurgery (SRS)Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. |
| Stereotactic Radiosurgery (40 Gray x 5 fractions)+Temozolomide | Experimental | Drug: Temozolomide, Procedure: Stereotactic Radiosurgery (SRS)Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histopathologically confirmed newly diagnosed glioblastoma multiforme. Diagnosis must be made by surgical biopsy or excision
- The tumor must be supratentorial in location
- The planning target volume (tumor plus margin) must measure ≤ 150 cm^3 in volume
- Age ≥ 18 years
- Life expectancy of at least 12 weeks
Key exclusion criteria (6 listed)
- Patients who have previously been treated with brain irradiation to the region that would result in overlap of the radiation fields
- Tumor foci detected below the tentorium
- Multifocal disease or leptomeningeal spread
- Prior allergic reaction to the study drugs involved in this protocol
- Patients with pacemaker will be allowed to undergo CT instead of MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemozolomideAlso: Temodar, Temodal75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy. | Drug | Stereotactic Radiosurgery (25 Gray x 5 fractions)+Temozolomide, Stereotactic Radiosurgery (30 Gray x 5 fractions)+Temozolomide, Stereotactic Radiosurgery (35 Gray x 5 fractions)+Temozolomide, Stereotactic Radiosurgery (40 Gray x 5 fractions)+Temozolomide |
| Stereotactic Radiosurgery (SRS)Also: Hypofractionated stereotactic radiosurgery (h-SRS), Hypofractionated stereotactic radiotherapy, Cyberknife surgeryStandard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy) | Procedure or surgery | Stereotactic Radiosurgery (25 Gray x 5 fractions)+Temozolomide, Stereotactic Radiosurgery (30 Gray x 5 fractions)+Temozolomide, Stereotactic Radiosurgery (35 Gray x 5 fractions)+Temozolomide, Stereotactic Radiosurgery (40 Gray x 5 fractions)+Temozolomide |
Primary outcome
Number of Dose-limiting Toxicities (DLTs)
Time frame: 30 days
The maximum-tolerated dose (MTD) of study treatment (temozolomid plus hypofractionated radiotherapy administered as 5 fractions) is defined as either: * The highest radiation dose per protocol, or * The radiation dose at which dose-limiting toxicities (DLTs) occurred in ≥ 2 of 3 participants at a dose level, and/or ≥ 2 of 6 participants, at a dose level. Dose-limiting toxicity (DLT) was defined as a treatment-related (with possible, probable or definite attribution) Grade 3 to 5 CNS toxicity [Common Terminology Criteria for Adverse Events (CTCAE) v4] occurring within 30 days of stereotactic radiosurgery (SRS). The non-stratified outcome is reported as the number of DLTs observed in by radiation dose and by strata (Planning Target Volume (PTV) < 60 cm³ and from 60 to 150 cm³).
9 secondary outcomes
Number of Acute Toxicity Within 30 Days
Time frame: 30 days
Long-term Toxicity After More Than 30 Days
Time frame: 12 months
Percent of Participants With Radiographic Response
Time frame: 6 months
Progression-free Survival
Time frame: 18 Months.
Overall Survival (OS)
Time frame: 20 Months.
Quality of Life by European Organisation for Research and Treatment of Cancer (EORTC-QLQ C30) Survey
Time frame: 12 Months
Quality of Life by Brain-20 Survey
Time frame: 12 months
Quality of Life by MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Survey
Time frame: 12 months
Treatment Failure Analysis
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Gerard Soltys, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Temozolomide and Stereotactic Radiosurgery (SRS) in people with Glioblastoma and Cancer of Brain and Nervous System, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Dose-limiting Toxicities (DLTs) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.