Trial · NCT00590967
A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy
NCT00590967, Phase 2, Terminated, Washington University School of Medicine; results first posted 2016-08-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy. Trials, record NCT00590967. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00590967
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy
- NCT number
- NCT00590967
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 69 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Cervical Cancer
- Interventions
- IMRT extended field external beam radiation therapy, Brachytherapy, Cisplatin
- First posted
- 2008-01-11
- Last updated
- 2016-08-29
- Results first posted
- 2016-08-29
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity | 1 year post start of radiation therapy | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting. |
| Primary | Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher) | 30 days after completion of radiation therapy | |
| Primary | Efficacy of IMRT Extended-field Radiation Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by PET Scan Disease Status | 1st PET scan after completion of treatment (approximately month 6) | |
| Secondary | Efficacy of IMRT to the Para-aortic Lymph Nodes, IMRT External Beam Radiotherapy to the Pelvis, Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by the Frequency of Distant Metastasis | 5 years after completion of radiation therapy |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity | 1 year post start of radiation therapy | participants | NUMBER | |
| PRIMARY | Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher) | 30 days after completion of radiation therapy | participants | NUMBER | |
| PRIMARY | Efficacy of IMRT Extended-field Radiation Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by PET Scan Disease Status | 1st PET scan after completion of treatment (approximately month 6) | participants | NUMBER | |
| SECONDARY | Efficacy of IMRT to the Para-aortic Lymph Nodes, IMRT External Beam Radiotherapy to the Pelvis, Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by the Frequency of Distant Metastasis | 5 years after completion of radiation therapy | The data was not collected for this secondary outcome. Due to the the early termination of this study, only data for the primary outcomes were collected and analyzed. |
Source ClinicalTrials.gov
Results by group136
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | Neutropenia | 3 | participants | |
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | Neutropenia | 1 | participants | |
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | Anorexia | 1 | participants | |
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | Anorexia | 1 | participants | |
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | Diarrhea | 1 | participants | |
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | Diarrhea | 1 | participants | |
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | Hypomagnesemia | 1 | participants | |
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | Hypomagnesemia | 0 | participants | |
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | Leukopenia | 2 | participants | |
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | Leukopenia | 3 | participants |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | 44 | |
| Overall Study | STARTED | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | 25 | |
| Overall Study | COMPLETED | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | 41 | |
| Overall Study | COMPLETED | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | 20 | |
| Overall Study | NOT COMPLETED | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | 3 | |
| Overall Study | NOT COMPLETED | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | 5 |
Source ClinicalTrials.gov
Adverse events226
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 Group 1 (IMRT, Brachytherapy, Cisplatin) | 9 | 41 | |
| other | Abdominal pain | Gastrointestinal disorders | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | 4 | 20 | |
| other | Absolute neutrophil count (ANC) | Investigations | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | 10 | 41 | |
| other | Absolute neutrophil count (ANC) | Investigations | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | 11 | 20 | |
| other | Albumin | Metabolism and nutrition disorders | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | 3 | 41 | |
| other | Albumin | Metabolism and nutrition disorders | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | 3 | 20 | |
| other | Alkaline phosphatase | Investigations | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | 4 | 41 | |
| other | Alkaline phosphatase | Investigations | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | 6 | 20 | |
| other | Anorexia | Metabolism and nutrition disorders | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | 16 | 41 | |
| other | Anorexia | Metabolism and nutrition disorders | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | 16 | 20 |
1 to 10 of 226Source ClinicalTrials.gov
See all 226 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | ||
| Total, all-cause mortality | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | ||
| Total, other adverse events | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | 41 | 41 |
| Total, other adverse events | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | 20 | 20 |
| Total, serious adverse events | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | 10 | 41 |
| Total, serious adverse events | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | 4 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) vs Treatment Group 2 (IMRT, Brachytherapy, Cisplatin): 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/NCT00590967
GET https://conductscience.org/api/trials/v1/NCT00590967/results?page=2