Trial · NCT01466686
Low Dose Radiation Therapy for Glioblastoma Multiforme
NCT01466686, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2023-07-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Low Dose Radiation Therapy for Glioblastoma Multiforme. Trials, record NCT01466686. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01466686
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Low Dose Radiation Therapy for Glioblastoma Multiforme
- NCT number
- NCT01466686
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- High Grade Glioma
- Interventions
- Low Dose Fractionated Radiation Therapy (LDFRT), Temozolomide
- First posted
- 2011-11-08
- Last updated
- 2023-07-03
- Results first posted
- 2023-07-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate | 3, 6 and 12 month follow-up after therapy has been completed | To estimate the response rate to salvage temozolomide plus LDFRT. |
| Primary | Overall Survival Rate | up to 12 months after completion of temozolomide (48 weeks of treatment) | Overall survival rate is calculated as the median number of months that patients were alive for the cohort |
| Secondary | Progression Free Survival Rate | up to 12 months after completion of temozolomide (48 weeks of treatment) | Progression free survival rate is calculated as the median number of months for the cohort until patient's disease worsened/progressed |
| Secondary | Number of Patients With Hematologic Toxicities | Approximately every month from study start until 48 weeks, and then up to 12 months after completion of temozolomide at 3, 6, and 12 months follow up | The number of patients with grade 3+ hematologic toxicities. |
| Secondary | Number of Patients With Neurologic Toxicity | Approximately every month from study start until 48 weeks, and then up to 12 months after completion of temozolomide at 3, 6, and 12 months follow up | The number of patients with reported grade 3+ neurologic toxicities |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate | 3, 6 and 12 month follow-up after therapy has been completed | This data was not collected | ||
| PRIMARY | Overall Survival Rate | up to 12 months after completion of temozolomide (48 weeks of treatment) | months | MEDIAN | |
| SECONDARY | Progression Free Survival Rate | up to 12 months after completion of temozolomide (48 weeks of treatment) | months | MEDIAN | |
| SECONDARY | Number of Patients With Hematologic Toxicities | Approximately every month from study start until 48 weeks, and then up to 12 months after completion of temozolomide at 3, 6, and 12 months follow up | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients With Neurologic Toxicity | Approximately every month from study start until 48 weeks, and then up to 12 months after completion of temozolomide at 3, 6, and 12 months follow up | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival Rate | Temozolomide With Low Dose Fractionated Radiation Therapy | 9.6 | 95% Confidence Interval 7.0 to 15.4 | months | |
| Progression Free Survival Rate | Temozolomide With Low Dose Fractionated Radiation Therapy | 7.3 | 95% Confidence Interval 5.6 to 11.0 | months | |
| Number of Patients With Hematologic Toxicities | Temozolomide With Low Dose Fractionated Radiation Therapy | 8 | Participants | ||
| Number of Patients With Neurologic Toxicity | Temozolomide With Low Dose Fractionated Radiation Therapy | 6 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Temozolomide With Low Dose Fractionated Radiation Therapy | 31 | |
| Overall Study | COMPLETED | Temozolomide With Low Dose Fractionated Radiation Therapy | 30 | |
| Overall Study | NOT COMPLETED | Temozolomide With Low Dose Fractionated Radiation Therapy | 1 |
Source ClinicalTrials.gov
Adverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Temozolomide With Low Dose Fractionated Radiation Therapy | 1 | 30 | |
| serious | Death (Disease Progression) | General disorders | Temozolomide With Low Dose Fractionated Radiation Therapy | 19 | 30 | |
| serious | Death (NOS) | General disorders | Temozolomide With Low Dose Fractionated Radiation Therapy | 4 | 30 | |
| serious | Aphasia | Nervous system disorders | Temozolomide With Low Dose Fractionated Radiation Therapy | 1 | 30 | |
| serious | Disease Progression | General disorders | Temozolomide With Low Dose Fractionated Radiation Therapy | 6 | 30 | |
| serious | Fatigue | General disorders | Temozolomide With Low Dose Fractionated Radiation Therapy | 1 | 30 | |
| serious | Intraparenchymal Hemorrhage of Brain | Nervous system disorders | Temozolomide With Low Dose Fractionated Radiation Therapy | 1 | 30 | |
| serious | Lymphocyte Count Decrease | Investigations | Temozolomide With Low Dose Fractionated Radiation Therapy | 1 | 30 | |
| serious | Personality/Behavioral CTC | Psychiatric disorders | Temozolomide With Low Dose Fractionated Radiation Therapy | 1 | 30 | |
| serious | ALT increased | Investigations | Temozolomide With Low Dose Fractionated Radiation Therapy | 2 | 30 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Temozolomide With Low Dose Fractionated Radiation Therapy | 28 | 30 |
| Total, other adverse events | Temozolomide With Low Dose Fractionated Radiation Therapy | 0 | 0 |
| Total, serious adverse events | Temozolomide With Low Dose Fractionated Radiation Therapy | 30 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01466686
GET https://conductscience.org/api/trials/v1/NCT01466686/events?page=2