Trial · NCT01182350
Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG)
NCT01182350, Phase 2, Terminated, Karen D. Wright MD; results first posted 2019-09-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG). Trials, record NCT01182350. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01182350
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG)
- NCT number
- NCT01182350
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- Karen D. Wright MD
- Conditions
- Diffuse Intrinsic Pontine Glioma
- Interventions
- Bevacizumab, Erlotinib, Temozolomide, Radiation
- First posted
- 2010-08-16
- Last updated
- 2019-09-04
- Results first posted
- 2019-09-04
- Limitations and caveats
The study was terminated early having met the pre-specified stopping rule which required 3 or more cohorts with at least 10 patients each or 2 cohorts with at least 15 patients each in the first 50 patients with informative biopsies.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 9-month Overall Survival (OS) Rate | 9 months | 9-month overall survival is the percentage of participants remaining alive 9 months from registration. |
| Secondary | Rate of Lethal Complications From Surgery | 2 weeks | The rate of lethal complications from surgery is the percentage of participants dying as a result of surgery. |
| Secondary | Grade 3-4 Post-Procedural Surgery-Related Toxicity Rate | 2 weeks | Grade 3-4 post-procedural surgery-related toxicity rate is the percentage of participants experiencing at least one grade 3-4 adverse event (AE) during the post-procedural time frame of 14 days attributable to the surgical procedure based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4). |
| Secondary | Delay in Radiation Therapy Start | 3 weeks | The number of participants delaying the start of radiation therapy by more than 3 weeks due to complications as a result of surgical biopsy to obtain diagnostic tumor sample. |
| Secondary | Feasibility Rate of Molecular Approach to Therapy | 3 weeks | Feasibility rate of the molecular strategy is based on the percentage of participants either with inadequate tissue from surgical biopsy to confirm DIPG diagnosis and/or with uninterpretable results for identification of EGFR overexpression and MGMT methylation status. |
| Secondary | Number of Participants With Grade 3-4 Treatment-Related Toxicity Over Chemoradiation Therapy | Adverse events were routinely throughout treatment. Treatment duration was a median of 6.4 months (range 0.4-13.4 months) in this study cohort. | Counts any participant experiencing at least one treatment-related grade 3 or 4 adverse event (AE) with treatment attribution of possibly, probably or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) over chemoradiation therapy as reported on case report forms. |
| Secondary | Median Progression Free Survival (PFS) | Disease assessments using a standard CNS imaging protocol occurred chemoradiation cycles 1 and 2, every other maintenance cycle, every 3 months post-treatment year 1 then annually until PD or therapy change; In this study cohort, follow-up was up to 34m. | PFS based on the Kaplan-Meier method is defined as the duration of time \[months (m)\] from study entry to documented disease progression (PD) or death. Participants alive without PD are censored at the date of last disease assessment. For intrinsic pontine brainstem gliomas, only one lesion/mass is present at diagnosis. Comparisons of maximal 2-dimensional measurements, TxW (product of the longest diameter \[width (W)\] and its longest perpendicular diameter \[transverse (T)\]) are used to assess response for this target lesion. PD is 25% or more increase, taking as reference the smallest product observed since the start of treatment, or the appearance of one or more new lesions. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 9-month Overall Survival (OS) Rate | 9 months | The analysis population is comprised of the subset of participants who underwent biopsy, obtained a molecularly-based treatment assignment and started assigned chemoradiation therapy. | percentage of participants | NUMBER |
| SECONDARY | Rate of Lethal Complications From Surgery | 2 weeks | percentage of participants | NUMBER | |
| SECONDARY | Grade 3-4 Post-Procedural Surgery-Related Toxicity Rate | 2 weeks | The analysis dataset is comprised of all enrolled participants who underwent stereotactic biopsy. | percentage of participants | NUMBER |
| SECONDARY | Delay in Radiation Therapy Start | 3 weeks | The analysis dataset is comprised of all enrolled participants who underwent stereotactic biopsy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Feasibility Rate of Molecular Approach to Therapy | 3 weeks | The analysis dataset is comprised of all enrolled participants who underwent stereotactic biopsy. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Grade 3-4 Treatment-Related Toxicity Over Chemoradiation Therapy | Adverse events were routinely throughout treatment. Treatment duration was a median of 6.4 months (range 0.4-13.4 months) in this study cohort. | The analysis population is comprised of the subset of participants who underwent surgical biopsy, obtained a molecularly-based treatment assignment and started assigned chemoradiation therapy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Progression Free Survival (PFS) | Disease assessments using a standard CNS imaging protocol occurred chemoradiation cycles 1 and 2, every other maintenance cycle, every 3 months post-treatment year 1 then annually until PD or therapy change; In this study cohort, follow-up was up to 34m. | The analysis population is comprised of the subset of participants who underwent surgical biopsy, obtained a molecularly-based treatment assignment and started assigned chemoradiation therapy. The PFS was aggregated across cohorts per statistical analysis plan to evaluate the effect of the molecular strategy. | months | MEDIAN |
| POST_HOC | 9-month Overall Survival (OS) Rate by Molecular Cohort | 9 months | The analysis population is comprised of the subset of participants who underwent surgical biopsy, obtained a molecularly-based treatment assignment and started assigned chemoradiation therapy. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 9-month Overall Survival (OS) Rate | All Patients Starting Assigned Chemoradiation | 64.4 | 90% Confidence Interval 51.1 to 76.3 | percentage of participants | |
| Rate of Lethal Complications From Surgery | All Biopsied Participants | 0.0 | 90% Confidence Interval 0.0 to 5.8 | percentage of participants | |
| Grade 3-4 Post-Procedural Surgery-Related Toxicity Rate | All Biopsied Participants | 10.0 | 90% Confidence Interval 4.1 to 19.9 | percentage of participants | |
| Delay in Radiation Therapy Start | All Biopsied Participants | 1 | Participants | ||
| Feasibility Rate of Molecular Approach to Therapy | All Biopsied Participants | 92.0 | 90% Confidence Interval 82.6 to 97.2 | percentage of participants | |
| Number of Participants With Grade 3-4 Treatment-Related Toxicity Over Chemoradiation Therapy | Cohort 1 MGMT-/EGFR- | 5 | Participants | ||
| Number of Participants With Grade 3-4 Treatment-Related Toxicity Over Chemoradiation Therapy | Cohort 2 MGMT-/EGFR+ | 5 | Participants | ||
| Number of Participants With Grade 3-4 Treatment-Related Toxicity Over Chemoradiation Therapy | Cohort 3: MGMT+/EGFR- | 0 | Participants | ||
| Number of Participants With Grade 3-4 Treatment-Related Toxicity Over Chemoradiation Therapy | Cohort 4. MGMT+/EGFR+ | 0 | Participants | ||
| Median Progression Free Survival (PFS) | All Patients Starting Assigned Chemoradiation | 8 | Full Range 1 to 16 | months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow25
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: MGMT-/EGFR- | 30 | |
| Overall Study | STARTED | Cohort 2: MGMT-/EGFR+ | 14 | |
| Overall Study | STARTED | Cohort 3 MGMT+/EGFR- | 3 | |
| Overall Study | STARTED | Cohort 4. MGMT+/EGFR+ | 3 | |
| Overall Study | STARTED | Ineligible for Direct Treatment Assignment | 3 | |
| Overall Study | Underwent Stereotactic Biopsy | Cohort 1: MGMT-/EGFR- | 30 | |
| Overall Study | Underwent Stereotactic Biopsy | Cohort 2: MGMT-/EGFR+ | 14 | |
| Overall Study | Underwent Stereotactic Biopsy | Cohort 3 MGMT+/EGFR- | 3 | |
| Overall Study | Underwent Stereotactic Biopsy | Cohort 4. MGMT+/EGFR+ | 3 | |
| Overall Study | Underwent Stereotactic Biopsy | Ineligible for Direct Treatment Assignment | 0 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events944
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 | Abdominal distension | Gastrointestinal disorders | Cohort 1 MGMT-/EGFR- | 3 | 30 | |
| other | Abdominal distension | Gastrointestinal disorders | Cohort 2 MGMT-/EGFR+ | 1 | 14 | |
| other | Abdominal distension | Gastrointestinal disorders | Cohort 3: MGMT+/EGFR- | 0 | 3 | |
| other | Abdominal distension | Gastrointestinal disorders | Cohort 4. MGMT+/EGFR+ | 0 | 3 | |
| other | Abdominal infection | Infections and infestations | Cohort 1 MGMT-/EGFR- | 1 | 30 | |
| other | Abdominal infection | Infections and infestations | Cohort 2 MGMT-/EGFR+ | 0 | 14 | |
| other | Abdominal infection | Infections and infestations | Cohort 3: MGMT+/EGFR- | 0 | 3 | |
| other | Abdominal infection | Infections and infestations | Cohort 4. MGMT+/EGFR+ | 0 | 3 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 1 MGMT-/EGFR- | 7 | 30 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 2 MGMT-/EGFR+ | 2 | 14 |
1 to 10 of 944Source ClinicalTrials.gov
See all 944 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 MGMT-/EGFR- | 29 | 30 |
| Total, all-cause mortality | Cohort 2 MGMT-/EGFR+ | 14 | 14 |
| Total, all-cause mortality | Cohort 3: MGMT+/EGFR- | 3 | 3 |
| Total, all-cause mortality | Cohort 4. MGMT+/EGFR+ | 2 | 3 |
| Total, other adverse events | Cohort 1 MGMT-/EGFR- | 30 | 30 |
| Total, other adverse events | Cohort 2 MGMT-/EGFR+ | 14 | 14 |
| Total, other adverse events | Cohort 3: MGMT+/EGFR- | 3 | 3 |
| Total, other adverse events | Cohort 4. MGMT+/EGFR+ | 3 | 3 |
| Total, serious adverse events | Cohort 1 MGMT-/EGFR- | 8 | 30 |
| Total, serious adverse events | Cohort 2 MGMT-/EGFR+ | 9 | 14 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29741745 | RESULT |
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 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/NCT01182350
GET https://conductscience.org/api/trials/v1/NCT01182350/flow?page=2