TriangleNCT01182350 · STUDY IN CONTEXT
Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG)
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
9-month overall survival is the percentage of participants remaining alive 9 months from registration.
The rate of lethal complications from surgery is the percentage of participants dying as a result of surgery.
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).
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- trial label
- Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG)
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 4
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- outcome key
- om-0000
- source section id
- NCT01182350-om-0000
- source outcome index
- 0
- endpoint
- 9-month Overall Survival (OS) Rate
- endpoint definition
- 9-month overall survival is the percentage of participants remaining alive 9 months from registration.
- time origin
- 9 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis population is comprised of the subset of participants who underwent biopsy, obtained a molecularly-based treatment assignment and started assigned chemoradiation therapy.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- outcome key
- om-0001
- source section id
- NCT01182350-om-0001
- source outcome index
- 1
- endpoint
- Rate of Lethal Complications From Surgery
- endpoint definition
- The rate of lethal complications from surgery is the percentage of participants dying as a result of surgery.
- time origin
- 2 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- outcome key
- om-0002
- source section id
- NCT01182350-om-0002
- source outcome index
- 2
- endpoint
- Grade 3-4 Post-Procedural Surgery-Related Toxicity Rate
- endpoint definition
- 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).
- time origin
- 2 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis dataset is comprised of all enrolled participants who underwent stereotactic biopsy.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- outcome key
- om-0003
- source section id
- NCT01182350-om-0003
- source outcome index
- 3
- endpoint
- Delay in Radiation Therapy Start
- endpoint definition
- 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.
- time origin
- 3 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis dataset is comprised of all enrolled participants who underwent stereotactic biopsy.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- outcome key
- om-0004
- source section id
- NCT01182350-om-0004
- source outcome index
- 4
- endpoint
- Feasibility Rate of Molecular Approach to Therapy
- endpoint definition
- 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.
- time origin
- 3 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis dataset is comprised of all enrolled participants who underwent stereotactic biopsy.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- outcome key
- om-0005
- source section id
- NCT01182350-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants With Grade 3-4 Treatment-Related Toxicity Over Chemoradiation Therapy
- endpoint definition
- 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.
- time origin
- 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.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- outcome key
- om-0000
- arm key
- OG000
- arm label
- All Patients Starting Assigned Chemoradiation
- regimen
- Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Treatment directed based on tumor biopsy results requires classification of patients into 1 of 4 potential cohorts: O\^6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status (negative versus positive) and epidermal growth factor receptor (EGFR) overexpression status (negative versus positive).
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01182350-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- outcome key
- om-0001
- arm key
- OG000
- arm label
- All Biopsied Participants
- regimen
- Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Treatment directed based on tumor biopsy results requires classification of patients into 1 of 4 potential cohorts: O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status (negative versus positive) and epidermal growth factor receptor (EGFR) overexpression status (negative versus positive).
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01182350-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- outcome key
- om-0002
- arm key
- OG000
- arm label
- All Biopsied Participants
- regimen
- Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Treatment directed based on tumor biopsy results requires classification of patients into 1 of 4 potential cohorts: O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status (negative versus positive) and epidermal growth factor receptor (EGFR) overexpression status (negative versus positive).
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01182350-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- outcome key
- om-0003
- arm key
- OG000
- arm label
- All Biopsied Participants
- regimen
- Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Treatment directed based on tumor biopsy results requires classification of patients into 1 of 4 potential cohorts: O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status (negative versus positive) and epidermal growth factor receptor (EGFR) overexpression status (negative versus positive).
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01182350-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- outcome key
- om-0004
- arm key
- OG000
- arm label
- All Biopsied Participants
- regimen
- Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Treatment directed based on tumor biopsy results requires classification of patients into 1 of 4 potential cohorts: O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status (negative versus positive) and epidermal growth factor receptor (EGFR) overexpression status (negative versus positive).
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01182350-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Cohort 1 MGMT-/EGFR-
- regimen
- Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01182350-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Cohort 2 MGMT-/EGFR+
- regimen
- Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01182350-om-0005#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- outcome key
- om-0005
- arm key
- OG002
- arm label
- Cohort 3: MGMT+/EGFR-
- regimen
- Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01182350-om-0005#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- outcome key
- om-0005
- arm key
- OG003
- arm label
- Cohort 4. MGMT+/EGFR+
- regimen
- Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01182350-om-0005#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- harm key
- EG000
- source section id
- NCT01182350-ae
- event group key
- EG000
- event group label
- Cohort 1 MGMT-/EGFR-
- serious affected
- 8
- serious at risk
- 30
- other affected
- 30
- other at risk
- 30
- frequency threshold
- 0
- collection period
- 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.
- event definition
- Maximum grade toxicity by type was first calculated within each arm. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term. The analysis population is comprised of the subset of participants who underwent surgical biopsy.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- harm key
- EG001
- source section id
- NCT01182350-ae
- event group key
- EG001
- event group label
- Cohort 2 MGMT-/EGFR+
- serious affected
- 9
- serious at risk
- 14
- other affected
- 14
- other at risk
- 14
- frequency threshold
- 0
- collection period
- 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.
- event definition
- Maximum grade toxicity by type was first calculated within each arm. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term. The analysis population is comprised of the subset of participants who underwent surgical biopsy.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- harm key
- EG002
- source section id
- NCT01182350-ae
- event group key
- EG002
- event group label
- Cohort 3: MGMT+/EGFR-
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- 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.
- event definition
- Maximum grade toxicity by type was first calculated within each arm. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term. The analysis population is comprised of the subset of participants who underwent surgical biopsy.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT01182350
- harm key
- EG003
- source section id
- NCT01182350-ae
- event group key
- EG003
- event group label
- Cohort 4. MGMT+/EGFR+
- serious affected
- 2
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- 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.
- event definition
- Maximum grade toxicity by type was first calculated within each arm. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term. The analysis population is comprised of the subset of participants who underwent surgical biopsy.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice