Trial · NCT01402063
PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
NCT01402063, Phase 2, Completed, Brown University; results first posted 2015-06-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation. Trials, record NCT01402063. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01402063
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
- NCT number
- NCT01402063
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- Brown University
- Conditions
- Glioblastoma Multiforme
- Interventions
- PPX (CT2103), Temozolomide
- First posted
- 2011-07-26
- Last updated
- 2020-02-17
- Results first posted
- 2015-06-11
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival PPX/RT Versus TMZ/RT for Patients With GBM Without Methylation | Q 3 months on study then Q3 months in f/u for yr 1, q 4 months yr 2, q 6 months for approximately 4 ys. | MRI response evaluated by RANO criteria * Complete Response (CR): Circumstance when the enhancing tumor is no longer seen by neuroimaging, with the patient off all steroids or on adrenal maintenance only; CR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan coding a response. * Partial Response (PR): Decrease of \> 50% in the product of two diameters. Patients should be receiving stable or decreasing doses of steroids. PR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan. * Progression (P): A \> 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. This will not need a confirmatory scan. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of XRT. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival PPX/RT Versus TMZ/RT for Patients With GBM Without Methylation | Q 3 months on study then Q3 months in f/u for yr 1, q 4 months yr 2, q 6 months for approximately 4 ys. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival PPX/RT Versus TMZ/RT for Patients With GBM Without Methylation | Radiation Plus PPX(CT2103 | 31 | participants | ||
| Progression Free Survival PPX/RT Versus TMZ/RT for Patients With GBM Without Methylation | Radiation + Temozolomide | 15 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Radiation Plus PPX(CT2103 | 42 | |
| Overall Study | STARTED | Radiation + Temozolomide | 21 | |
| Overall Study | COMPLETED | Radiation Plus PPX(CT2103 | 39 | |
| Overall Study | COMPLETED | Radiation + Temozolomide | 18 | |
| Overall Study | NOT COMPLETED | Radiation Plus PPX(CT2103 | 3 | |
| Overall Study | NOT COMPLETED | Radiation + Temozolomide | 3 |
Source ClinicalTrials.gov
Adverse events382
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 |
|---|---|---|---|---|---|---|
| other | abnormal blood prolactin | Investigations | Radiation Plus PPX and Maintenance | 1 | 41 | 1 |
| other | abnormal blood prolactin | Investigations | Radiation + Temozolomide and Maintenance | 0 | 18 | 0 |
| other | abrasions/lacerations: face, leg, finger | Investigations | Radiation Plus PPX and Maintenance | 3 | 41 | 3 |
| other | abrasions/lacerations: face, leg, finger | Investigations | Radiation + Temozolomide and Maintenance | 0 | 18 | 0 |
| other | Acute gastroenteritis | Investigations | Radiation Plus PPX and Maintenance | 1 | 41 | 1 |
| other | Acute gastroenteritis | Investigations | Radiation + Temozolomide and Maintenance | 0 | 18 | 0 |
| other | Acne On Face and B/L Inguinal Region | Investigations | Radiation Plus PPX and Maintenance | 1 | 41 | 1 |
| other | Acne On Face and B/L Inguinal Region | Investigations | Radiation + Temozolomide and Maintenance | 0 | 18 | 0 |
| other | Agitation | Investigations | Radiation Plus PPX and Maintenance | 2 | 41 | 2 |
| other | Agitation | Investigations | Radiation + Temozolomide and Maintenance | 0 | 18 | 0 |
1 to 10 of 382Source ClinicalTrials.gov
See all 382 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Radiation Plus PPX and Maintenance | ||
| Total, all-cause mortality | Radiation + Temozolomide and Maintenance | ||
| Total, other adverse events | Radiation Plus PPX and Maintenance | 40 | 41 |
| Total, other adverse events | Radiation + Temozolomide and Maintenance | 18 | 18 |
| Total, serious adverse events | Radiation Plus PPX and Maintenance | 13 | 41 |
| Total, serious adverse events | Radiation + Temozolomide and Maintenance | 7 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23388562 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Radiation Plus PPX(CT2103 vs Radiation + Temozolomide: Progression Free Survival PPX/RT Versus TMZ/RT for Patients With GBM Without Methylation | Trial comparisons |
| Radiation Plus PPX and Maintenance vs Radiation + Temozolomide and Maintenance: serious adverse events | Trial comparisons |
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/NCT01402063
GET https://conductscience.org/api/trials/v1/NCT01402063/events?page=2