TriangleNCT04526886 · STUDY IN CONTEXT
Clinical Trial of a Novel Dose Adjustment Algorithm for Preventing Cytopenia-Related Delays During FOLFOX Chemotherapy
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
Number of patients with any interruption of chemotherapy leading to a cycle length of \>18 days that is not anticipated as of day 3 of the preceding treatment cycle.
Number of patients meeting the composite endpoint of 1) febrile neutropenia (grade 3 or 4), 2) major bleeding with concurrent grade 3 thrombocytopenia (platelet count \<50,000/mm3), 3) CTCAE grade 4 neutropenia (ANC \<500/mm3), and/or 4) CTCAE grade 4 thrombocytopenia (platelet count \<25,000/mm3)
Relative dose intensity (RDI) of chemotherapy. RDI is defined as (planned cumulative dose/cumulative administered dose)\*(actual duration/planned duration). RDI will be calculated separately for each component of the FOLFOX regimen (5-FU bolus, 5-FU infusion, oxaliplatin).
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-malignant-appendix-neoplasm
- nct id
- NCT04526886
- trial label
- Clinical Trial of a Novel Dose Adjustment Algorithm for Preventing Cytopenia-Related Delays During FOLFOX Chemotherapy
- 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
- 3
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT04526886
- outcome key
- om-0000
- source section id
- NCT04526886-om-0000
- source outcome index
- 0
- endpoint
- Unplanned Chemotherapy Treatment Delay
- endpoint definition
- Number of patients with any interruption of chemotherapy leading to a cycle length of \>18 days that is not anticipated as of day 3 of the preceding treatment cycle.
- time origin
- Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days)
- 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-malignant-appendix-neoplasm
- nct id
- NCT04526886
- outcome key
- om-0001
- source section id
- NCT04526886-om-0001
- source outcome index
- 1
- endpoint
- Composite Safety Endpoint
- endpoint definition
- Number of patients meeting the composite endpoint of 1) febrile neutropenia (grade 3 or 4), 2) major bleeding with concurrent grade 3 thrombocytopenia (platelet count \<50,000/mm3), 3) CTCAE grade 4 neutropenia (ANC \<500/mm3), and/or 4) CTCAE grade 4 thrombocytopenia (platelet count \<25,000/mm3)
- time origin
- Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days)
- 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-malignant-appendix-neoplasm
- nct id
- NCT04526886
- outcome key
- om-0002
- source section id
- NCT04526886-om-0002
- source outcome index
- 2
- endpoint
- Relative Dose Intensity of Chemotherapy
- endpoint definition
- Relative dose intensity (RDI) of chemotherapy. RDI is defined as (planned cumulative dose/cumulative administered dose)\*(actual duration/planned duration). RDI will be calculated separately for each component of the FOLFOX regimen (5-FU bolus, 5-FU infusion, oxaliplatin).
- time origin
- Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days)
- 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT04526886
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Evaluable Participants
- regimen
- All study participants evaluable for the primary outcome
- analyzed count
- 48
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04526886-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT04526886
- outcome key
- om-0001
- arm key
- OG000
- arm label
- All Enrolled Participants
- regimen
- All participants enrolled in the study - includes participants who were not evaluable for the primary study outcome
- analyzed count
- 52
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04526886-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT04526886
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Participants Completing Six Cycles of FOLFOX
- regimen
- Participants completing six cycles of FOLFOX (evaluable population for relative dose intensity)
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04526886-om-0002#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-appendix-neoplasm
- nct id
- NCT04526886
- harm key
- EG000
- source section id
- NCT04526886-ae
- event group key
- EG000
- event group label
- All Enrolled Participants
- serious affected
- 0
- serious at risk
- 52
- other affected
- 4
- other at risk
- 52
- frequency threshold
- 5
- collection period
- Adverse event data were collected between the date of registration and the day 1 of the cycle 6 of FOLFOX chemotherapy (14-day planned cycle length).
- 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