Trial · NCT00941070
Triapine, Cisplatin, and Radiation Therapy in Treating Patients With Cervical Cancer or Vaginal Cancer
NCT00941070, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Triapine, Cisplatin, and Radiation Therapy in Treating Patients With Cervical Cancer or Vaginal Cancer. Trials, record NCT00941070. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00941070
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Triapine, Cisplatin, and Radiation Therapy in Treating Patients With Cervical Cancer or Vaginal Cancer
- NCT number
- NCT00941070
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Recurrent Cervical Cancer, Recurrent Vaginal Cancer, Stage IB Cervical Cancer, Stage II Vaginal Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage III Vaginal Cancer, Stage IVA Cervical Cancer, Stage IVA Vaginal Cancer, Stage IVB Cervical Cancer, Stage IVB Vaginal Cancer, Therapy-related Toxicity
- Interventions
- triapine, cisplatin, external beam radiation therapy, quality-of-life assessment, questionnaire administration, fludeoxyglucose F 18, positron emission tomography, computed tomography
- First posted
- 2009-07-17
- Last updated
- 2017-11-17
- Results first posted
- 2013-05-13
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Fasting F-18 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) Imaging Complete Metabolic Response, Reported Following National Cancer Institute (NCI) and European Organization for Research and Treatment of Cancer (EORTC) Guidelines. | post therapy at 3 months | To quantitate change in pre-treatment standard uptake value (SUV) on PET/CT and posttreatment PET/CT or disease progression PET/CT. Change in PET/CT SUV will be associated with 3-month best overall clinical response. |
| Secondary | Clinical and Objective Response Assignment | post therapy at 3 months | Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study. |
| Secondary | Clinical and Objective Response Assignment | one month follow up assessment | Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study. |
| Secondary | Clinical and Objective Response Assignment | three month follow up assessment | Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study. |
| Secondary | Percent of Patients With Incidence of Grade 2 or Higher Gastrointestinal and Genitourinary Toxicity, Assessed Using CTCAE v3.0 Until December 31, 2010 and CTCAE v4.0 Beginning January 1, 2011 | After 5 weeks of radiation therapy | Information will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Frequency tables will be constructed to summarize observed incidence by severity and type of toxicity. |
| Secondary | Progression-free Survival | at 18 months from study entry | Percentage of patients that did not have disease progression. Estimates of progression-free survival will be computed using the product-limit estimate of Kaplan and Meier. |
| Secondary | PET/CT Scan Metabolic Activity | Baseline (pre-therapy) | Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses. |
| Secondary | PET/CT Scan Metabolic Activity | 3 months post-treatment | Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses. |
| Secondary | PET/CT Scan Metabolic Activity | Up to 5 years | Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses. |
| Secondary | Change in Sexual Function, Assessed Using the Sexual Function-Vaginal Changes Questionnaire | Baseline to up to 5 years |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Fasting F-18 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) Imaging Complete Metabolic Response, Reported Following National Cancer Institute (NCI) and European Organization for Research and Treatment of Cancer (EORTC) Guidelines. | post therapy at 3 months | 1 patient was non-compliant and received no therapy. Pt was excluded from analyses. 1 patient died from an unrelated health event after completing radiation and experimental chemotherapy and did not undergo 3-month F-18 FDG study. | Standard uptake value (SUV) | MEDIAN |
| SECONDARY | Clinical and Objective Response Assignment | post therapy at 3 months | Patients that completed the 3-month F-18 FDG study. | participants | NUMBER |
| SECONDARY | Clinical and Objective Response Assignment | one month follow up assessment | Patients that completed the the 3-month 18F-FDG PET/CT. One patient died from an unrelated health event after completing radiation and experimental chemotherapy and was excluded from analyse. | participants | NUMBER |
| SECONDARY | Clinical and Objective Response Assignment | three month follow up assessment | Patients that completed the the 3-month 18F-FDG PET/CT. One patient died from an unrelated health event after completing radiation and experimental chemotherapy and was excluded from analyse. | participants | NUMBER |
| SECONDARY | Percent of Patients With Incidence of Grade 2 or Higher Gastrointestinal and Genitourinary Toxicity, Assessed Using CTCAE v3.0 Until December 31, 2010 and CTCAE v4.0 Beginning January 1, 2011 | After 5 weeks of radiation therapy | All patients who receive at least one dose of Triapine® and cisplatin treatment. | percentage of patients | NUMBER |
| SECONDARY | Progression-free Survival | at 18 months from study entry | Patients that completed the the 3-month 18F-FDG PET/CT. | percentage of patients | NUMBER |
| SECONDARY | PET/CT Scan Metabolic Activity | Baseline (pre-therapy) | Patients that completed the 3-month 18F-FDG PET/CT | Standard Uptake Value (SUV) | MEDIAN |
| SECONDARY | PET/CT Scan Metabolic Activity | 3 months post-treatment | Patients that completed 3-month 18F-FDG PET/CT | Standard Uptake Value (SUV) | MEDIAN |
| SECONDARY | PET/CT Scan Metabolic Activity | Up to 5 years | Data were not collected as the study was terminated prior to the time period for collection. | ||
| SECONDARY | Change in Sexual Function, Assessed Using the Sexual Function-Vaginal Changes Questionnaire | Baseline to up to 5 years | Data were not collected as the study was terminated prior to the time period for collection. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Fasting F-18 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) Imaging Complete Metabolic Response, Reported Following National Cancer Institute (NCI) and European Organization for Research and Treatment of Cancer (EORTC) Guidelines. | Treatment (Cisplatin, Triapine, Radiation Therapy) | Pretherapy SUV | 14.6 | Inter-Quartile Range 12.1 to 17.7 | Standard uptake value (SUV) |
Fasting F-18 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) Imaging Complete Metabolic Response, Reported Following National Cancer Institute (NCI) and European Organization for Research and Treatment of Cancer (EORTC) Guidelines. | Treatment (Cisplatin, Triapine, Radiation Therapy) | Posttherapy SUV | 2.6 | Inter-Quartile Range 2.0 to 3.4 | Standard uptake value (SUV) |
| Clinical and Objective Response Assignment | Treatment (Cisplatin, Triapine, Radiation Therapy) | 21 | participants | ||
| Clinical and Objective Response Assignment | Treatment (Cisplatin, Triapine, Radiation Therapy) | 23 | participants | ||
| Clinical and Objective Response Assignment | Treatment (Cisplatin, Triapine, Radiation Therapy) | 23 | participants | ||
| Percent of Patients With Incidence of Grade 2 or Higher Gastrointestinal and Genitourinary Toxicity, Assessed Using CTCAE v3.0 Until December 31, 2010 and CTCAE v4.0 Beginning January 1, 2011 | Treatment (Cisplatin, Triapine, Radiation Therapy) | 0 | percentage of patients | ||
| Progression-free Survival | Treatment (Cisplatin, Triapine, Radiation Therapy) | 67 | 95% Confidence Interval 56 to 78 | percentage of patients | |
| PET/CT Scan Metabolic Activity | Treatment (Cisplatin, Triapine, Radiation Therapy) | 14.6 | Inter-Quartile Range 12.1 to 17.7 | Standard Uptake Value (SUV) | |
| PET/CT Scan Metabolic Activity | Treatment (Cisplatin, Triapine, Radiation Therapy) | 2.6 | Inter-Quartile Range 2.0 to 3.4 | Standard Uptake Value (SUV) | |
| Change in Smoking Behavior, Assessed Using the Smoking Questionnaire and Cessation Counseling | Treatment (Cisplatin, Triapine, Radiation Therapy) | Non-Smokers | 9 | participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Cisplatin, Triapine, Radiation Therapy) | 26 | |
| Overall Study | COMPLETED | Treatment (Cisplatin, Triapine, Radiation Therapy) | 25 | |
| Overall Study | NOT COMPLETED | Treatment (Cisplatin, Triapine, Radiation Therapy) | 1 |
Source ClinicalTrials.gov
Adverse events69
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 | Abdominal pain | Gastrointestinal disorders | Treatment (Cisplatin, Triapine, Radiation Therapy) | 3 | 25 | |
| other | Alanine transaminase (ALT) increased | Investigations | Treatment (Cisplatin, Triapine, Radiation Therapy) | 6 | 25 | |
| other | Alkaline phosphatase increased | Investigations | Treatment (Cisplatin, Triapine, Radiation Therapy) | 3 | 25 | |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Cisplatin, Triapine, Radiation Therapy) | 24 | 25 | |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Cisplatin, Triapine, Radiation Therapy) | 3 | 25 | |
| other | Aspartate aminotransferase (AST) increased | Investigations | Treatment (Cisplatin, Triapine, Radiation Therapy) | 3 | 25 | |
| other | Chest Pain (non-cardiac) | General disorders | Treatment (Cisplatin, Triapine, Radiation Therapy) | 2 | 25 | |
| other | Constipation | Gastrointestinal disorders | Treatment (Cisplatin, Triapine, Radiation Therapy) | 10 | 25 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Treatment (Cisplatin, Triapine, Radiation Therapy) | 2 | 25 | |
| other | Depression | Psychiatric disorders | Treatment (Cisplatin, Triapine, Radiation Therapy) | 2 | 25 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Cisplatin, Triapine, Radiation Therapy) | ||
| Total, other adverse events | Treatment (Cisplatin, Triapine, Radiation Therapy) | 25 | 25 |
| Total, serious adverse events | Treatment (Cisplatin, Triapine, Radiation Therapy) | 9 | 25 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| P30CA043703 | Case Comprehensive Cancer Center Support Grant | SCHWARTZ, GARY K | CASE WESTERN RESERVE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1987 to 2025 | NIH RePORTER |
| U01CA062502 | Early Clinical Trials of New Anti-Cancer Agents with Phase I Emphasis | DOWLATI, AFSHIN | CASE WESTERN RESERVE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1994 to 2013 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00941070
GET https://conductscience.org/api/trials/v1/NCT00941070/events?page=2