TriangleNCT02466971 · STUDY IN CONTEXT
Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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 participants with hematologic toxicity during treatment period, where hematologic toxicity is defined as occurrence of any grade 3 or higher adverse events for neutropenia, leukopenia, lymphopenia, anemia, or thrombocytopenia. Adverse events are graded and categorized using CTCAE v4.0.
Number of participants with a maximum grade of 3 or higher that occurred during follow-up period. Adverse events are graded and categorized using CTCAE v4.0.
Peripheral blood methemoglobin collected at baseline and 1, 3, 5 and 24 hours after Triapine infusion on Day 1 in Arm II.
Estimate for probability of overall survival at 3 years by Kaplan-Meier method, where overall survival is defined as the time from randomization to time of death due to any cause or the date of last contact, whichever occurs first.
Estimate for probability of progression free at 3 years by Kaplan-Meier method, where progression-free survival is defined as the time from randomization to the date of first documented disease recurrence/progression, death from any cause or date of last contact, whichever occurs first. Recurrence is defined as clinical, radiological or histological evidence of recurrent disease post study treatment. Disease progression will be determined from the physical examinations, which were conducted during treatment (day 9, 16, 23, 30 and 37) and follow-up (1 and 3 months after completing protocol therapy, every 3 months for years 1 and 2, and every 6 months for years 3, 4 and 5), and the PET/CT scan conducted 3 months after the end of treatment. Please note that progression defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) is not required by the protocol.
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
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-cervical-cancer-mvasi-228add04
- nct id
- NCT02466971
- trial label
- Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- 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
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-mvasi-228add04
- nct id
- NCT02466971
- outcome key
- om-0003
- source section id
- NCT02466971-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants With Hematologic Toxicity During Treatment Period
- endpoint definition
- Number of participants with hematologic toxicity during treatment period, where hematologic toxicity is defined as occurrence of any grade 3 or higher adverse events for neutropenia, leukopenia, lymphopenia, anemia, or thrombocytopenia. Adverse events are graded and categorized using CTCAE v4.0.
- time origin
- Up to 30 days after completion of study treatment
- analysis role
- exploratory
- reporting status
- NOT_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-cervical-cancer-mvasi-228add04
- nct id
- NCT02466971
- outcome key
- om-0004
- source section id
- NCT02466971-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Adverse Events (Grade 3 or Higher) That Occurred During Follow-Up Period
- endpoint definition
- Number of participants with a maximum grade of 3 or higher that occurred during follow-up period. Adverse events are graded and categorized using CTCAE v4.0.
- time origin
- Up to 5 years
- analysis role
- exploratory
- reporting status
- NOT_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-cervical-cancer-mvasi-228add04
- nct id
- NCT02466971
- outcome key
- om-0005
- source section id
- NCT02466971-om-0005
- source outcome index
- 5
- endpoint
- Peripheral Blood Methemoglobin
- endpoint definition
- Peripheral blood methemoglobin collected at baseline and 1, 3, 5 and 24 hours after Triapine infusion on Day 1 in Arm II.
- time origin
- Baseline to 24 hours after triapine infusion
- analysis role
- exploratory
- reporting status
- NOT_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-cervical-cancer-mvasi-228add04
- nct id
- NCT02466971
- outcome key
- om-0000
- source section id
- NCT02466971-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival (OS) Rate at 3 Years
- endpoint definition
- Estimate for probability of overall survival at 3 years by Kaplan-Meier method, where overall survival is defined as the time from randomization to time of death due to any cause or the date of last contact, whichever occurs first.
- time origin
- At 3 years from randomization.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible participants
- 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-cervical-cancer-mvasi-228add04
- nct id
- NCT02466971
- outcome key
- om-0001
- source section id
- NCT02466971-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival (PFS) Rate at 3 Years
- endpoint definition
- Estimate for probability of progression free at 3 years by Kaplan-Meier method, where progression-free survival is defined as the time from randomization to the date of first documented disease recurrence/progression, death from any cause or date of last contact, whichever occurs first. Recurrence is defined as clinical, radiological or histological evidence of recurrent disease post study treatment. Disease progression will be determined from the physical examinations, which were conducted during treatment (day 9, 16, 23, 30 and 37) and follow-up (1 and 3 months after completing protocol therapy, every 3 months for years 1 and 2, and every 6 months for years 3, 4 and 5), and the PET/CT scan conducted 3 months after the end of treatment. Please note that progression defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) is not required by the protocol.
- time origin
- At 3 years from study randomization.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible participants
- 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-cervical-cancer-mvasi-228add04
- nct id
- NCT02466971
- outcome key
- om-0002
- source section id
- NCT02466971-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
- endpoint definition
- Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
- time origin
- During treatment period and up to 30 days after stopping the study treatment with a median treatment time as 53 days ranging from 1 to 189 days.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who received any study treatment
- 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-cervical-cancer-mvasi-228add04
- nct id
- NCT02466971
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm I (Cisplatin, IMRT or RT, Brachytherapy)
- regimen
- Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV External Beam Radiation Therapy: Undergo EBRT Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT
- analyzed count
- 224
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02466971-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-mvasi-228add04
- nct id
- NCT02466971
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
- regimen
- Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT Triapine: Given IV
- analyzed count
- 224
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02466971-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-mvasi-228add04
- nct id
- NCT02466971
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm I (Cisplatin, IMRT or RT, Brachytherapy)
- regimen
- Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV External Beam Radiation Therapy: Undergo EBRT Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT
- analyzed count
- 224
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02466971-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-mvasi-228add04
- nct id
- NCT02466971
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
- regimen
- Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT Triapine: Given IV
- analyzed count
- 224
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02466971-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-mvasi-228add04
- nct id
- NCT02466971
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm I (Cisplatin, IMRT or RT, Brachytherapy)
- regimen
- Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV External Beam Radiation Therapy: Undergo EBRT Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT
- analyzed count
- 208
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02466971-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-mvasi-228add04
- nct id
- NCT02466971
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
- regimen
- Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT Triapine: Given IV
- analyzed count
- 202
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02466971-om-0002#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-mvasi-228add04
- nct id
- NCT02466971
- harm key
- EG000
- source section id
- NCT02466971-ae
- event group key
- EG000
- event group label
- Arm I (Cisplatin, IMRT or RT, Brachytherapy)
- serious affected
- 45
- serious at risk
- 208
- other affected
- 198
- other at risk
- 208
- frequency threshold
- 0
- collection period
- All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
- event definition
- All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
- 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-cervical-cancer-mvasi-228add04
- nct id
- NCT02466971
- harm key
- EG001
- source section id
- NCT02466971-ae
- event group key
- EG001
- event group label
- Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
- serious affected
- 45
- serious at risk
- 202
- other affected
- 194
- other at risk
- 202
- frequency threshold
- 0
- collection period
- All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
- event definition
- All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
- 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