Trial · NCT02466971
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
NCT02466971, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2024-01-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT02466971. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02466971
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT02466971
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 450 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Advanced Vaginal Adenocarcinoma, Advanced Vaginal Adenosquamous Carcinoma, Advanced Vaginal Squamous Cell Carcinoma, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Stage IB2 Cervical Cancer AJCC v6 and v7, Stage II Cervical Cancer AJCC v7, Stage II Vaginal Cancer AJCC v6 and v7, Stage IIA Cervical Cancer AJCC v7, Stage IIB Cervical Cancer AJCC v6 and v7, Stage III Vaginal Cancer AJCC v6 and v7, Stage IIIB Cervical Cancer AJCC v6 and v7, Stage IV Vaginal Cancer AJCC v6 and v7, Stage IVA Cervical Cancer AJCC v6 and v7, Stage IVA Vaginal Cancer AJCC v6 and v7, Unresectable Vaginal Carcinoma, Vaginal Adenocarcinoma, Vaginal Adenosquamous Carcinoma, Vaginal Carcinoma, Vaginal Squamous Cell Carcinoma, Not Otherwise Specified
- Interventions
- Brachytherapy, Cisplatin, External Beam Radiation Therapy, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Radiation Therapy, Triapine
- First posted
- 2015-06-09
- Last updated
- 2026-10-22
- Results first posted
- 2024-01-05
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) Rate at 3 Years | At 3 years from randomization. | 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. |
| Secondary | Progression-free Survival (PFS) Rate at 3 Years | At 3 years from study randomization. | 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. |
| Secondary | Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period | 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. | Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0. |
| Other | Number of Participants With Hematologic Toxicity During Treatment Period | Up to 30 days after completion of study treatment | 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. |
| Other | Number of Participants With Adverse Events (Grade 3 or Higher) That Occurred During Follow-Up Period | Up to 5 years | 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. |
| Other | Peripheral Blood Methemoglobin | Baseline to 24 hours after triapine infusion | Peripheral blood methemoglobin collected at baseline and 1, 3, 5 and 24 hours after Triapine infusion on Day 1 in Arm II. |
| Other | Metabolic Complete Response (mCR) | Up to 3 months after completion of treatment | The assessment of metabolic complete response is based on the ratio of post 3-month therapy PET/CT maximum standardized update value (SUV) to pre-therapy PET/CT maximum SUV. The metabolic complete response is classified as complete response for a ratio of 0.33 or less, or partial response for a ratio between 0.34 and 0.75, or stable response for a ratio greater that 0.75 but less than 1.25, or progressive response for a ratio greater than 1.25. |
| Other | Intensity Modulated Radiation Therapy (IG-IMRT) | Up to 60 days. | Number of Participants with KBP IG-IMRT |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) Rate at 3 Years | At 3 years from randomization. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) Rate at 3 Years | At 3 years from study randomization. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period | 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. | Participants who received any study treatment | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Hematologic Toxicity During Treatment Period | Up to 30 days after completion of study treatment | |||
| OTHER_PRE_SPECIFIED | Number of Participants With Adverse Events (Grade 3 or Higher) That Occurred During Follow-Up Period | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Peripheral Blood Methemoglobin | Baseline to 24 hours after triapine infusion | |||
| OTHER_PRE_SPECIFIED | Metabolic Complete Response (mCR) | Up to 3 months after completion of treatment | |||
| OTHER_PRE_SPECIFIED | Intensity Modulated Radiation Therapy (IG-IMRT) | Up to 60 days. |
Source ClinicalTrials.gov
Results by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) Rate at 3 Years | Arm I (Cisplatin, IMRT or RT, Brachytherapy) | 78.1 | 95% Confidence Interval 70 to 84 | percentage of participants | |
| Overall Survival (OS) Rate at 3 Years | Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | 79.6 | 95% Confidence Interval 72 to 85 | percentage of participants | |
| Progression-free Survival (PFS) Rate at 3 Years | Arm I (Cisplatin, IMRT or RT, Brachytherapy) | 69.5 | 95% Confidence Interval 62 to 76 | percentage of participants | |
| Progression-free Survival (PFS) Rate at 3 Years | Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | 71.4 | 95% Confidence Interval 64 to 78 | percentage of participants | |
| Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period | Arm I (Cisplatin, IMRT or RT, Brachytherapy) | Anemia | 23 | Participants | |
| Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period | Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | Anemia | 18 | Participants | |
| Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period | Arm I (Cisplatin, IMRT or RT, Brachytherapy) | Other blood and lymphatic system disorders | 5 | Participants | |
| Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period | Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | Other blood and lymphatic system disorders | 7 | Participants | |
| Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period | Arm I (Cisplatin, IMRT or RT, Brachytherapy) | White blood cell count decreased | 19 | Participants | |
| Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period | Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | White blood cell count decreased | 17 | Participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Cisplatin, IMRT or RT, Brachytherapy) | 225 | |
| Overall Study | STARTED | Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | 225 | |
| Overall Study | COMPLETED | Arm I (Cisplatin, IMRT or RT, Brachytherapy) | 207 | |
| Overall Study | COMPLETED | Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | 202 | |
| Overall Study | NOT COMPLETED | Arm I (Cisplatin, IMRT or RT, Brachytherapy) | 18 | |
| Overall Study | NOT COMPLETED | Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | 23 |
Source ClinicalTrials.gov
Adverse events604
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thrombotic Thrombocytopenic Purpura | Blood and lymphatic system disorders | Arm I (Cisplatin, IMRT or RT, Brachytherapy) | 0 | 208 | |
| other | Thrombotic Thrombocytopenic Purpura | Blood and lymphatic system disorders | Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | 1 | 202 | |
| other | Lymph Node Pain | Blood and lymphatic system disorders | Arm I (Cisplatin, IMRT or RT, Brachytherapy) | 0 | 208 | |
| other | Lymph Node Pain | Blood and lymphatic system disorders | Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | 1 | 202 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm I (Cisplatin, IMRT or RT, Brachytherapy) | 2 | 208 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | 4 | 202 | |
| other | Blood And Lymphatic System Disorders - Other | Blood and lymphatic system disorders | Arm I (Cisplatin, IMRT or RT, Brachytherapy) | 1 | 208 | |
| other | Blood And Lymphatic System Disorders - Other | Blood and lymphatic system disorders | Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | 2 | 202 | |
| other | Anemia | Blood and lymphatic system disorders | Arm I (Cisplatin, IMRT or RT, Brachytherapy) | 105 | 208 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | 105 | 202 |
1 to 10 of 604Source ClinicalTrials.gov
See all 604 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Cisplatin, IMRT or RT, Brachytherapy) | 35 | 224 |
| Total, all-cause mortality | Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | 34 | 224 |
| Total, other adverse events | Arm I (Cisplatin, IMRT or RT, Brachytherapy) | 198 | 208 |
| Total, other adverse events | Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | 194 | 202 |
| Total, serious adverse events | Arm I (Cisplatin, IMRT or RT, Brachytherapy) | 45 | 208 |
| Total, serious adverse events | Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine) | 45 | 202 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Cisplatin, IMRT or RT, Brachytherapy) vs Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine): deaths from any cause | Trial comparisons |
| Arm I (Cisplatin, IMRT or RT, Brachytherapy) vs Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02466971
GET https://conductscience.org/api/trials/v1/NCT02466971/results?page=2