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A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma
Phase 2 trial testing High Dose Radiation in Glioma in 26 participants. Completed in 18 November 2020.
| Lead sponsor | University of Michigan Rogel Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 22 September 2016 |
| Primary completion | 6 February 2020 |
| Estimated completion | 18 November 2020 |
| Sites | 1 location across United States |
University of Michigan Rogel Cancer Center
18 and older, any sex, with Glioma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of patients alive at 12 months after completion of chemoradiation
| Group | Value | 95% CI |
|---|---|---|
| High Dose Chemoradiation | 74 | 56 – 92 |
| Group | Value | 95% CI |
|---|---|---|
| High Dose Chemoradiation | 92 | 78 – 100 |
Median overall survival in months
| Group | Value | 95% CI |
|---|---|---|
| High Dose Chemoradiation | 20 | 14 – 29 |
| Group | Value | 95% CI |
|---|---|---|
| High Dose Chemoradiation | 20 | 18 – 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 progr
| Group | Value | 95% CI |
|---|---|---|
| High Dose Chemoradiation | 10 | 7 – 17 |
| Group | Value | 95% CI |
|---|---|---|
| High Dose Chemoradiation | 12 | 10 – 17 |
Tumor volume will be measured by diffusion MRI and perfusion MRI before treatment start and at mid-treatment.
| Group | Value | 95% CI |
|---|---|---|
| High Dose Chemoradiation | -2.9 | -5.3 – -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 Muc
| Group | Value | 95% CI |
|---|---|---|
| High Dose Chemoradiation | 26 |
| Group | Value | 95% CI |
|---|---|---|
| High Dose Chemoradiation | 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.
| Group | Value | 95% CI |
|---|---|---|
| High Dose Chemoradiation | 31 |
| Group | Value | 95% CI |
|---|---|---|
| High Dose Chemoradiation | 69 |
Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | All Enrolled Patients |
|---|---|---|
| Nervous system disorders - Other | Nervous system disorders | — |
| Confusion | Psychiatric disorders | — |
| Thromboembolic event | Vascular disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Localized edema | General disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Wound infection | Infections and infestations | — |
| Muscle weakness left-sided | Musculoskeletal and connective tissue disorders | — |
| Muscle weakness right-sided | Musculoskeletal and connective tissue disorders | — |
| Headache | Nervous system disorders | — |
| Reaction | System | All Enrolled Patients |
|---|---|---|
| Fatigue | General disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Headache | Nervous system disorders | — |
| Platelet count decreased | Investigations | — |
| Dizziness | Nervous system disorders | — |
| Insomnia | Psychiatric disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| General disorders and administration site conditions - Other | General disorders | — |
| Pain | General disorders | — |
| Muscle weakness right-sided | Musculoskeletal and connective tissue disorders | — |
| Paresthesia | Nervous system disorders | — |
| Depression | Psychiatric disorders | — |
| Eye disorders - Other | Eye disorders | — |
| Allergic reaction | Immune system disorders | — |
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Dysarthria | Nervous system disorders | — |
| Seizure | Nervous system disorders | — |
| Anxiety | Psychiatric disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Hearing impaired | Ear and labyrinth disorders | — |
| Blurred vision | Eye disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Edema face | General disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Investigations - Other | Investigations | — |
| Lymphocyte count decreased | Investigations | — |
| Weight gain | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | — |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Dysphasia | Nervous system disorders | — |
| Confusion | Psychiatric disorders | — |
| Urinary frequency | Renal and urinary disorders | — |
| Ventricular tachycardia | Cardiac disorders | — |
| Ear and labyrinth disorders - Other | Ear and labyrinth disorders | — |
Most-reported serious reactions: Nervous system disorders - Other, Confusion, Thromboembolic event, Nausea, Localized edema, Urinary tract infection, Wound infection, Muscle weakness left-sided.
Data from ClinicalTrials.gov NCT02805179 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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