A Phase 2 interventional study of High Dose Radiation and Temozolomide in Glioma, sponsored by University of Michigan Rogel Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-15.
Sponsored by University of Michigan Rogel Cancer Center · Phase 2, Interventional, and Treatment
This is a study to determine the safety and effectiveness of high-dose radiation therapy (RT) with concurrent temozolomide in patients with newly diagnosed glioblastoma.
After analysis demonstrated the improved prognostic value of identifying both hypercellular tumor (TVHCV) based on high b-value diffusion-weighted magnetic resonance imaging (DW-MRI) and hyperperfused tumor (TVCBV) based on dynamic contrast-enhanced MRI (DCE-MRI), the study was amended and later-enrolled patients boosted to both TVHCV and TVCBV.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 26 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
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Exclusion Criteria:
Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide.
Radiation: High Dose Radiation · Drug: Temozolomide
Radiation will be delivered once daily for a total of 30 fractions, five days per week.
Patients will receive concurrent temozolomide (75 mg/m\^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m\^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.
Overall Survival at 12 Months
Percentage of patients alive at 12 months after completion of chemoradiation
Time frame: 12 months after completion of chemoradiation
Median Overall Survival
Median overall survival in months
Time frame: Median follow-up time was 26 months
Median Progression-free Survival
From start of RT until disease progression or death, or until date of last imaging follow-up, estimated using Kaplan-Meier. Progression is defined by any of the following: \>= 25% increase in sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids; a significant increase in T2/FLAIR non-enhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy, not due to comorbid events; appearance of any new lesions; clear progression of non-measurable lesions; or definite clinical deterioration not attributable to causes other than tumor, or to decrease in corticosteroid dose. When pathologic confirmation was unavailable, progression was defined as worsening enhancement based on imaging with or without adjunctive advanced imaging including perfusion MRI or magnetic resonance spectroscopy, when clinically indicated.
Time frame: Median follow-up time was 26 months
Median Change in Tumor Volume From Baseline to Mid-radiation Treatment (Week 4)
Tumor volume will be measured by diffusion MRI and perfusion MRI before treatment start and at mid-treatment.
Time frame: Baseline to Week 4
Percentage of Patients That Experienced Deterioration in Quality of Life (QOL)
Percentage of patients that experienced deterioration in QOL per the European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-C30). EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.
Time frame: Baseline to 1 and 7 months
Percentage of Patients With Failure; Central or In-field vs. Marginal or Distant
Failures will be classified as central or in-field, marginal or distant based on previously published criteria. 1) "central," in which 95% or more of the recurrent tumor volume (Vrecur) was within D95, the region treated to high dose (95% of the prescription dose); 2) "in-field," in which 80% or more of Vrecur was within the D95 isodose surface; 3) "marginal," when between 20 and 80% of Vrecur was inside the D95 surface; 4) "outside," in which less than 20% of Vrecur was inside the D95 surface.
Time frame: Median 26 months
| Milestone | All Participants |
|---|---|
| Started | 26 |
| Eligible patients that started dose-intensified chemo-radiation | 23 |
| Subset of participants, boosted to both high b-value diffusion and perfusion | 13 |
| Completed | 23 |
| Not completed | 3 |
Percentage of patients alive at 12 months after completion of chemoradiation
| percentage of participants | High Dose Chemoradiation |
|---|---|
| all eligible patients who completed dose-intensified chemo-radiation | 74 (56 to 92) |
| only patients who were boosted to both diffusion and perfusion | 92 (78 to 100) |
Median overall survival in months
| months | High Dose Chemoradiation |
|---|---|
| all eligible patients who completed dose-intensified chemo-radiation | 20 (14 to 29) |
| only patients who were boosted to both diffusion and perfusion | 20 (18 to NA) |
From start of RT until disease progression or death, or until date of last imaging follow-up, estimated using Kaplan-Meier. Progression is defined by any of the following: \>= 25% increase in sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids; a significant increase in T2/FLAIR non-enhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy, not due to comorbid events; appearance of any new lesions; clear progression of non-measurable lesions; or definite clinical deterioration not attributable to causes other than tumor, or to decrease in corticosteroid dose. When pathologic confirmation was unavailable, progression was defined as worsening enhancement based on imaging with or without adjunctive advanced imaging including perfusion MRI or magnetic resonance spectroscopy, when clinically indicated.
| months | High Dose Chemoradiation |
|---|---|
| all eligible patients who completed dose-intensified chemo-radiation | 10 (7 to 17) |
| only patients who were boosted to both diffusion and perfusion | 12 (10 to 17) |
Tumor volume will be measured by diffusion MRI and perfusion MRI before treatment start and at mid-treatment.
| cubic centimeters | High Dose Chemoradiation |
|---|---|
| Median Change in Tumor Volume From Baseline to Mid-radiation Treatment (Week 4) | -2.9 (-5.3 to -1.8) |
Percentage of patients that experienced deterioration in QOL per the European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-C30). EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.
| percentage of participants | High Dose Chemoradiation |
|---|---|
| at 1 month | 26 |
| at 7 months | 33 |
Failures will be classified as central or in-field, marginal or distant based on previously published criteria. 1) "central," in which 95% or more of the recurrent tumor volume (Vrecur) was within D95, the region treated to high dose (95% of the prescription dose); 2) "in-field," in which 80% or more of Vrecur was within the D95 isodose surface; 3) "marginal," when between 20 and 80% of Vrecur was inside the D95 surface; 4) "outside," in which less than 20% of Vrecur was inside the D95 surface.
| percentage of participants | High Dose Chemoradiation |
|---|---|
| central or in-field | 31 |
| non-central/non-in-field (marginal or distant) | 69 |
Collected over Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Enrolled Patients | 21/26 (80.8%) | 8/26 (30.8%) | 25/26 (96.2%) |
| Event | All Enrolled Patients |
|---|---|
| Nervous system disorders - OtherNervous system disorders | 2/26 |
| ConfusionPsychiatric disorders | 2/26 |
| Thromboembolic eventVascular disorders | 2/26 |
| NauseaGastrointestinal disorders | 1/26 |
| Localized edemaGeneral disorders | 1/26 |
| Urinary tract infectionInfections and infestations | 1/26 |
| Wound infectionInfections and infestations | 1/26 |
| Muscle weakness left-sidedMusculoskeletal and connective tissue disorders | 1/26 |
| Muscle weakness right-sidedMusculoskeletal and connective tissue disorders | 1/26 |
| HeadacheNervous system disorders | 1/26 |
| Event | All Enrolled Patients |
|---|---|
| FatigueGeneral disorders | 20/26 |
| NauseaGastrointestinal disorders | 11/26 |
| ConstipationGastrointestinal disorders | 9/26 |
| HeadacheNervous system disorders | 8/26 |
| Platelet count decreasedInvestigations | 7/26 |
| DizzinessNervous system disorders | 7/26 |
| InsomniaPsychiatric disorders | 7/26 |
| AlopeciaSkin and subcutaneous tissue disorders | 6/26 |
| General disorders and administration site conditions - OtherGeneral disorders | 5/26 |
| PainGeneral disorders | 5/26 |
| Age, Continuous(years) | High Dose Chemoradiation |
|---|---|
| Mean | 62 (50 to 77) |
| Sex: Female, Male(Participants) | High Dose Chemoradiation |
|---|---|
| Female | 10 |
| Male | 16 |
| Ethnicity (NIH/OMB)(Participants) | High Dose Chemoradiation |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 26 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | High Dose Chemoradiation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 24 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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University of Michigan Rogel Cancer Center