Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced 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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The MTD was determined following a standard 3+3 design is as follows: Escalation at 0/3 DLTs, dose-reduction if \>1/3 DLT, and expansion to 6 if 1/3 DLTs. DLT is defined as the severe toxicity event that leads to the termination of the treatment as defined in section 5.5. The highest dose level where \<2/6 DLTs are observed will be declared MTD

All treated patients evaluable for DLTs

→

primary · POSTED

Number of patients that experienced a DLT, evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. DLTs are defined as the following adverse events if considered at least "possibly related" to a component of the study therapy and which occur from the start of treatment until completion of EBRT, prior to initiation of brachytherapy (i.e. the first 5 weeks if no treatments are missed): Any nausea, vomiting, diarrhea and elevation of serum creatinine level Grade 3 toxicity not resolved with maximal intervention to Grade 0-2 over 7 days (except alopecia and fatigue); Any nausea, vomiting, diarrhea and elevation of serum creatinine level Grade 4 toxicity; Any other non-hematologic toxicity ≥Grade 3; Any hematologic toxicity of ≥ Grade 4; Grade ≥3 dyspnea; Inability to deliver at least 20 of the scheduled 25 administrations of triapine at the planned dose, allowing for 2 weeks to make up missed radiation days. Inability to deliver

All treated patients evaluable for DLTs

→

primary · POSTED

The oral bioavailability of the oral form of the triapine will be measured as a numeric value using mass spectrophotometry.

Patients that had both PO and IV triapine PK samples

→

primary · POSTED

Maximum concentration

Treated patients for whom PK samples were able to be collected

→

primary · POSTED

Time to maximum concentration,

Treated patients for whom samples were able to be collected

→

primary · POSTED

Area Under the Concentration-Time Curve (AUC 0-last)

Treated patients for whom samples were able to be collected

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-keytruda-d88e44f2
nct id: NCT02595879
trial label: Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer
applicability: unclear
applicability note: Attached because the study's own record describes locally advanced 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-keytruda-d88e44f2
nct id
NCT02595879
outcome key
om-0000
source section id
NCT02595879-om-0000
source outcome index
0
endpoint
Maximum Tolerated Dose (MTD)
endpoint definition
The MTD was determined following a standard 3+3 design is as follows: Escalation at 0/3 DLTs, dose-reduction if \>1/3 DLT, and expansion to 6 if 1/3 DLTs. DLT is defined as the severe toxicity event that leads to the termination of the treatment as defined in section 5.5. The highest dose level where \<2/6 DLTs are observed will be declared MTD
time origin
Up to 5 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All treated patients evaluable for DLTs
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-keytruda-d88e44f2
nct id
NCT02595879
outcome key
om-0001
source section id
NCT02595879-om-0001
source outcome index
1
endpoint
Number of Patients Who Experienced a DLT
endpoint definition
Number of patients that experienced a DLT, evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. DLTs are defined as the following adverse events if considered at least "possibly related" to a component of the study therapy and which occur from the start of treatment until completion of EBRT, prior to initiation of brachytherapy (i.e. the first 5 weeks if no treatments are missed): Any nausea, vomiting, diarrhea and elevation of serum creatinine level Grade 3 toxicity not resolved with maximal intervention to Grade 0-2 over 7 days (except alopecia and fatigue); Any nausea, vomiting, diarrhea and elevation of serum creatinine level Grade 4 toxicity; Any other non-hematologic toxicity ≥Grade 3; Any hematologic toxicity of ≥ Grade 4; Grade ≥3 dyspnea; Inability to deliver at least 20 of the scheduled 25 administrations of triapine at the planned dose, allowing for 2 weeks to make up missed radiation days. Inability to deliver
time origin
Up to 5 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All treated patients evaluable for DLTs
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-keytruda-d88e44f2
nct id
NCT02595879
outcome key
om-0002
source section id
NCT02595879-om-0002
source outcome index
2
endpoint
Bioavailability of Triapine
endpoint definition
The oral bioavailability of the oral form of the triapine will be measured as a numeric value using mass spectrophotometry.
time origin
Up to 2 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients that had both PO and IV triapine PK samples
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-keytruda-d88e44f2
nct id
NCT02595879
outcome key
om-0003
source section id
NCT02595879-om-0003
source outcome index
3
endpoint
Cmax
endpoint definition
Maximum concentration
time origin
Up to 24 hours after dosing
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Treated patients for whom PK samples were able to be collected
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-keytruda-d88e44f2
nct id
NCT02595879
outcome key
om-0004
source section id
NCT02595879-om-0004
source outcome index
4
endpoint
Tmax
endpoint definition
Time to maximum concentration,
time origin
Up to 24 hours after dosing
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Treated patients for whom samples were able to be collected
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-keytruda-d88e44f2
nct id
NCT02595879
outcome key
om-0005
source section id
NCT02595879-om-0005
source outcome index
5
endpoint
AUC
endpoint definition
Area Under the Concentration-Time Curve (AUC 0-last)
time origin
Up to 24 hours after dosing
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Treated patients for whom samples were able to be collected
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-keytruda-d88e44f2
nct id
NCT02595879
outcome key
om-0000
arm key
OG000
arm label
All Participants
regimen
Patients who received at least 80% of PO triapine (either at 100mg or 150mg) and 80% of chemoradiation.
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595879-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT02595879
outcome key
om-0001
arm key
OG000
arm label
Triapine (100mg) + Chemoradiation)
regimen
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 100mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30).
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595879-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT02595879
outcome key
om-0001
arm key
OG001
arm label
Triapine (150mg) + Chemoradiation)
regimen
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 150mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30).
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595879-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT02595879
outcome key
om-0002
arm key
OG000
arm label
Triapine (100mg) + Chemoradiation)
regimen
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up. Biospecimen Collection: Undergo collection of blood samples Brachytherapy: Undergo LDR brachytherapy Cisplatin: Given IV Computed Tomography: Undergo FDG-PET/CT External Beam Radiation Therapy: Undergo pelvic EBRT Fludeoxyglucose F-18: Undergo FDG-PET/CT High-Dose Rate Brachytherapy: Undergo HDR brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT Magnetic Resonance Imaging: Undergo MRI Pharmacological Study: Correlative studies Positron Emission Tomography: Undergo FDG-PET/CT Triapine: Given IV and PO
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595879-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT02595879
outcome key
om-0002
arm key
OG001
arm label
Triapine (150mg) + Chemoradiation)
regimen
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595879-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT02595879
outcome key
om-0003
arm key
OG000
arm label
Triapine (100mg) + Chemoradiation)
regimen
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up. Biospecimen Collection: Undergo collection of blood samples Brachytherapy: Undergo LDR brachytherapy Cisplatin: Given IV Computed Tomography: Undergo FDG-PET/CT External Beam Radiation Therapy: Undergo pelvic EBRT Fludeoxyglucose F-18: Undergo FDG-PET/CT High-Dose Rate Brachytherapy: Undergo HDR brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT Magnetic Resonance Imaging: Undergo MRI Pharmacological Study: Correlative studies Positron Emission Tomography: Undergo FDG-PET/CT Triapine: Given IV and PO
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595879-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT02595879
outcome key
om-0003
arm key
OG001
arm label
Triapine (150mg) + Chemoradiation)
regimen
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595879-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT02595879
outcome key
om-0004
arm key
OG000
arm label
Triapine (100mg) + Chemoradiation)
regimen
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up. Biospecimen Collection: Undergo collection of blood samples Brachytherapy: Undergo LDR brachytherapy Cisplatin: Given IV Computed Tomography: Undergo FDG-PET/CT External Beam Radiation Therapy: Undergo pelvic EBRT Fludeoxyglucose F-18: Undergo FDG-PET/CT High-Dose Rate Brachytherapy: Undergo HDR brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT Magnetic Resonance Imaging: Undergo MRI Pharmacological Study: Correlative studies Positron Emission Tomography: Undergo FDG-PET/CT Triapine: Given IV and PO
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595879-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT02595879
outcome key
om-0004
arm key
OG001
arm label
Triapine (150mg) + Chemoradiation)
regimen
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595879-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT02595879
outcome key
om-0005
arm key
OG000
arm label
Triapine (100mg) + Chemoradiation)
regimen
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up. Biospecimen Collection: Undergo collection of blood samples Brachytherapy: Undergo LDR brachytherapy Cisplatin: Given IV Computed Tomography: Undergo FDG-PET/CT External Beam Radiation Therapy: Undergo pelvic EBRT Fludeoxyglucose F-18: Undergo FDG-PET/CT High-Dose Rate Brachytherapy: Undergo HDR brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT Magnetic Resonance Imaging: Undergo MRI Pharmacological Study: Correlative studies Positron Emission Tomography: Undergo FDG-PET/CT Triapine: Given IV and PO
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595879-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT02595879
outcome key
om-0005
arm key
OG001
arm label
Triapine (150mg) + Chemoradiation)
regimen
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595879-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-d88e44f2
nct id
NCT02595879
harm key
EG000
source section id
NCT02595879-ae
event group key
EG000
event group label
Triapine (100mg) + Chemoradiation)
serious affected
8
serious at risk
17
other affected
17
other at risk
17
frequency threshold
0
collection period
Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
event definition
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
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-keytruda-d88e44f2
nct id
NCT02595879
harm key
EG001
source section id
NCT02595879-ae
event group key
EG001
event group label
Triapine (150mg) + Chemoradiation)
serious affected
2
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
event definition
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
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