TriangleNCT02162732 · STUDY IN CONTEXT
Molecular-Guided Therapy for Childhood Cancer
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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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
The definition of feasibility is: Enrollment onto study, genomic profile, analysis and report generation completed, tumor board held with treatment decision, treatment review completed, start of treatment, and completion of 1 cycle of therapy.
To determine the safety of allowing a molecular tumor board to determine individualized treatment plans
To determine the activity of treatments chosen based on Overall response rate (ORR) using RESIST criteria. The assessment of response will include the initial measurable targets and will be performed after cycle 2, then after every other cycle. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI imaging and/or by MIBG or PET scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, At least a 20% increase in the sum of the disease measurements for measurable lesions, Stable Disease, Neither sufficient decrease to qualify for PR or sufficient increase to qualify for PD from study entry. Overall Response (OR) = CR + PR.
Time to progression (PFS), defined as the period from the start of the treatment until the criteria for progression are met taking as reference the screening measurements. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment (nadir), and minimum 5 mm increase over the nadir or the appearance of one or more new lesions or appearance of positive bone marrow.
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-ewing-sarcoma
- nct id
- NCT02162732
- trial label
- Molecular-Guided Therapy for Childhood Cancer
- 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- 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
- 4
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT02162732
- outcome key
- om-0000
- source section id
- NCT02162732-om-0000
- source outcome index
- 0
- endpoint
- Days to Treatment Will be Used in Order to Determine Feasibility of Using Tumor Samples to Assess Genomic Sequencing Using Predictive Modeling to Make Real-time Treatment Decisions for Children With Relapsed/Refractory Cancers.
- endpoint definition
- The definition of feasibility is: Enrollment onto study, genomic profile, analysis and report generation completed, tumor board held with treatment decision, treatment review completed, start of treatment, and completion of 1 cycle of therapy.
- time origin
- 2 years
- analysis role
- primary
- 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-ewing-sarcoma
- nct id
- NCT02162732
- outcome key
- om-0001
- source section id
- NCT02162732-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants With an Unexpected Adverse Events as a Measure of Safety
- endpoint definition
- To determine the safety of allowing a molecular tumor board to determine individualized treatment plans
- time origin
- Adverse Events were collected starting with the date of the first dose of study drug until 30 days after last dose of study drug, ongoing related adverse events were continued to be followed until resolution, on average of 4 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All subjects that received at least one dose of study 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-ewing-sarcoma
- nct id
- NCT02162732
- outcome key
- om-0002
- source section id
- NCT02162732-om-0002
- source outcome index
- 2
- endpoint
- Overall Response Rate (ORR) of Participants by the Presence of Radiologically Assessable Disease by Cross-sectional CT or MRI Imaging and/or by MIBG or PET Scans.
- endpoint definition
- To determine the activity of treatments chosen based on Overall response rate (ORR) using RESIST criteria. The assessment of response will include the initial measurable targets and will be performed after cycle 2, then after every other cycle. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI imaging and/or by MIBG or PET scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, At least a 20% increase in the sum of the disease measurements for measurable lesions, Stable Disease, Neither sufficient decrease to qualify for PR or sufficient increase to qualify for PD from study entry. Overall Response (OR) = CR + PR.
- time origin
- Followed until off therapy, generally 4 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Having at least one disease evaluation following completion of at least one cycle of molecular-guided 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-ewing-sarcoma
- nct id
- NCT02162732
- outcome key
- om-0003
- source section id
- NCT02162732-om-0003
- source outcome index
- 3
- endpoint
- Progression Free Survival (PFS) Interval Will be Measured by Days and Compared to the PFS of Previous Chemotherapy Regimens Since Relapse for Each Patient.
- endpoint definition
- Time to progression (PFS), defined as the period from the start of the treatment until the criteria for progression are met taking as reference the screening measurements. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment (nadir), and minimum 5 mm increase over the nadir or the appearance of one or more new lesions or appearance of positive bone marrow.
- time origin
- From date of start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Time on study was measured in days from the date of initial biopsy to date of last administration of study therapy. For subjects with \>1 biopsies and \>1 MGT regimens, the off-therapy date from their last treatment was used.
- 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-ewing-sarcoma
- nct id
- NCT02162732
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Neuroblastoma
- regimen
- Subjects on study with a diagnosis of Neuroblastoma
- analyzed count
- 31
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02162732-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT02162732
- outcome key
- om-0000
- arm key
- OG001
- arm label
- CNS Tumors
- regimen
- Subjects on study with a diagnosis of a CNS Tumor which included, but was not limited to, Ependymoma, Glioblastoma, Diffuse Midline Glioma, and Other CNS Tumors.
- analyzed count
- 41
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02162732-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT02162732
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Rare Tumors
- regimen
- Subjects on study with a diagnosis of a rare solid tumor which included, but was not limited to, Rhabdomyosarcoma, Ewing Sarcoma, Osteosarcoma, and Other Rare Tumors.
- analyzed count
- 72
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02162732-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT02162732
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Guided Therapy
- regimen
- A total of 200 neuroblastoma, brain tumor, and rare tumor patients will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles). Guided Therapy: A total of 200 neuroblastoma, brain tumor, and rare tumor patients will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
- analyzed count
- 144
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02162732-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT02162732
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Neuroblastoma
- regimen
- Subjects on study with a diagnosis of Neuroblastoma
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02162732-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT02162732
- outcome key
- om-0002
- arm key
- OG001
- arm label
- CNS Tumors
- regimen
- Subjects on study with a diagnosis of a CNS Tumor which included, but was not limited to, Ependymoma, Glioblastoma, Diffuse Midline Glioma, and Other CNS Tumors.
- analyzed count
- 37
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02162732-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT02162732
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Rare Tumors
- regimen
- Subjects on study with a diagnosis of a rare solid tumor which included, but was not limited to, Rhabdomyosarcoma, Ewing Sarcoma, Osteosarcoma, and Other Rare Tumors.
- analyzed count
- 60
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02162732-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT02162732
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Neuroblastoma
- regimen
- Subjects on study with a diagnosis of Neuroblastoma
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02162732-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT02162732
- outcome key
- om-0003
- arm key
- OG001
- arm label
- CNS Tumors
- regimen
- Subjects on study with a diagnosis of a CNS Tumor which included, but was not limited to, Ependymoma, Glioblastoma, Diffuse Midline Glioma, and Other CNS Tumors.
- analyzed count
- 37
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02162732-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT02162732
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Rare Tumors
- regimen
- Subjects on study with a diagnosis of a rare solid tumor which included, but was not limited to, Rhabdomyosarcoma, Ewing Sarcoma, Osteosarcoma, and Other Rare Tumors.
- analyzed count
- 60
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02162732-om-0003#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT02162732
- harm key
- EG000
- source section id
- NCT02162732-ae
- event group key
- EG000
- event group label
- Guided Therapy
- serious affected
- 0
- serious at risk
- 144
- other affected
- 6
- other at risk
- 144
- frequency threshold
- 0
- collection period
- Adverse Events were collected starting with the date of the first dose of study drug until 30 days after last dose of study drug, ongoing related adverse events were continued to be followed until resolution, on average of 4 years.
- event definition
- Source null
- 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