Trial · NCT00262821
Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer
NCT00262821, Phase 3, Terminated, National Cancer Institute (NCI); results first posted 2017-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer. Trials, record NCT00262821. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00262821
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer
- NCT number
- NCT00262821
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 402 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Cervical Adenocarcinoma, Cervical Adenosquamous Cell Carcinoma, Cervical Squamous Cell Carcinoma, Stage IB Cervical Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage IVA Cervical Cancer
- Interventions
- cisplatin, tirapazamine
- First posted
- 2005-12-07
- Last updated
- 2019-07-23
- Results first posted
- 2017-07-02
- Limitations and caveats
- Premature closure due to lack of study drug leading to small number of subjects analyzed.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival - Percentage of Patients Alive and Progression Free | From study entry until first disease progression, death or date of last contact, up to 6 years | Patients' progression status based on clinical, radiological or pathological (histological) evidence of disease after study therapy. Progression includes any death without evidence of disease progression. Progression-free Survival (PFS) is defined as time in month from study enrollment to disease progression, death or date of last contact. |
| Secondary | Overall Survival | From study entry to death or last contact, up to 6 years | The observed length of life from entry into the study to death or date of last contact. |
| Secondary | Adverse Events (Grade 3 or Higher) During Treatment Period | All Adverse Events (AEs) occuring during treatment and up to 30 days after stopping the study treatment are reported | Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival - Percentage of Patients Alive and Progression Free | From study entry until first disease progression, death or date of last contact, up to 6 years | Eligible and evaluable patients | percentage of patients | NUMBER |
| SECONDARY | Overall Survival | From study entry to death or last contact, up to 6 years | Eligible and evaluable patients | percentage of patients alive | NUMBER |
| SECONDARY | Adverse Events (Grade 3 or Higher) During Treatment Period | All Adverse Events (AEs) occuring during treatment and up to 30 days after stopping the study treatment are reported | All Treated Patients | participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Progression-free Survival - Percentage of Patients Alive and Progression Free | Concurrent Cisplatin and Radiation | 64.4 | percentage of patients | ||
| Progression-free Survival - Percentage of Patients Alive and Progression Free | Concurrent Cisplatin, Tirapazamine and Radiation | 63.0 | percentage of patients | ||
| Overall Survival | Concurrent Cisplatin and Radiation | 70.6 | percentage of patients alive | ||
| Overall Survival | Concurrent Cisplatin, Tirapazamine and Radiation | 70.5 | percentage of patients alive | ||
| Adverse Events (Grade 3 or Higher) During Treatment Period | Concurrent Cisplatin and Radiation | Number Participants Analyzed | 190 | participants | |
| Adverse Events (Grade 3 or Higher) During Treatment Period | Concurrent Cisplatin, Tirapazamine and Radiation | Number Participants Analyzed | 180 | participants | |
| Adverse Events (Grade 3 or Higher) During Treatment Period | Concurrent Cisplatin and Radiation | Leukopenia | 51 | participants | |
| Adverse Events (Grade 3 or Higher) During Treatment Period | Concurrent Cisplatin, Tirapazamine and Radiation | Leukopenia | 53 | participants | |
| Adverse Events (Grade 3 or Higher) During Treatment Period | Concurrent Cisplatin and Radiation | Thrombocytopenia | 8 | participants | |
| Adverse Events (Grade 3 or Higher) During Treatment Period | Concurrent Cisplatin, Tirapazamine and Radiation | Thrombocytopenia | 6 | 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 | Concurrent Cisplatin and Radiation | 198 | |
| Overall Study | STARTED | Concurrent Cisplatin, Tirapazamine and Radiation | 204 | |
| Overall Study | COMPLETED | Concurrent Cisplatin and Radiation | 194 | |
| Overall Study | COMPLETED | Concurrent Cisplatin, Tirapazamine and Radiation | 185 | |
| Overall Study | NOT COMPLETED | Concurrent Cisplatin and Radiation | 4 | |
| Overall Study | NOT COMPLETED | Concurrent Cisplatin, Tirapazamine and Radiation | 19 |
Source ClinicalTrials.gov
Adverse events642
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 | Allergy/Immunology - Other | Immune system disorders | Concurrent Cisplatin and Radiation | 0 | 190 | |
| other | Allergy/Immunology - Other | Immune system disorders | Concurrent Cisplatin, Tirapazamine and Radiation | 1 | 180 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Concurrent Cisplatin and Radiation | 4 | 190 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Concurrent Cisplatin, Tirapazamine and Radiation | 6 | 180 | |
| other | Rhinitis | Immune system disorders | Concurrent Cisplatin and Radiation | 3 | 190 | |
| other | Rhinitis | Immune system disorders | Concurrent Cisplatin, Tirapazamine and Radiation | 4 | 180 | |
| other | Auditory/Ear - Other | Ear and labyrinth disorders | Concurrent Cisplatin and Radiation | 3 | 190 | |
| other | Auditory/Ear - Other | Ear and labyrinth disorders | Concurrent Cisplatin, Tirapazamine and Radiation | 2 | 180 | |
| other | Hearing (Without Monitoring Program) | Ear and labyrinth disorders | Concurrent Cisplatin and Radiation | 1 | 190 | |
| other | Hearing (Without Monitoring Program) | Ear and labyrinth disorders | Concurrent Cisplatin, Tirapazamine and Radiation | 4 | 180 |
1 to 10 of 642Source ClinicalTrials.gov
See all 642 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Concurrent Cisplatin and Radiation | ||
| Total, all-cause mortality | Concurrent Cisplatin, Tirapazamine and Radiation | ||
| Total, other adverse events | Concurrent Cisplatin and Radiation | 187 | 190 |
| Total, other adverse events | Concurrent Cisplatin, Tirapazamine and Radiation | 179 | 180 |
| Total, serious adverse events | Concurrent Cisplatin and Radiation | 42 | 190 |
| Total, serious adverse events | Concurrent Cisplatin, Tirapazamine and Radiation | 65 | 180 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24395863 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| U10CA027469 | Gynecologic Oncology Group | DISAIA, PHILIP J. | GYNECOLOGIC ONCOLOGY GROUP | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Concurrent Cisplatin and Radiation vs Concurrent Cisplatin, Tirapazamine and Radiation: serious adverse events |
Source 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/NCT00262821
GET https://conductscience.org/api/trials/v1/NCT00262821/results?page=2