Trial · NCT00012012
Radiation Therapy and Cisplatin With or Without Amifostine for Patients With Stage IIIB or IVA Cervical Cancer
NCT00012012, Phase 1, Phase 2, Completed, Radiation Therapy Oncology Group; results first posted 2015-01-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Radiation Therapy and Cisplatin With or Without Amifostine for Patients With Stage IIIB or IVA Cervical Cancer. Trials, record NCT00012012. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00012012
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy and Cisplatin With or Without Amifostine for Patients With Stage IIIB or IVA Cervical Cancer
- NCT number
- NCT00012012
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Cervical Cancer, Radiation Toxicity
- Interventions
- Amifostine trihydrate, Cisplatin, Intracavitary brachytherapy, External beam radiation therapy
- First posted
- 2003-01-27
- Last updated
- 2015-01-07
- Results first posted
- 2015-01-07
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia) | From start of treatment to 90 days | To determine the feasibility and tolerance of extended-field external radiotherapy to the pelvis and para-aortic region and intracavitary irradiation combined with weekly cisplatin using the rate of acute grade 3/4 toxicity rate (excluding grade 3 leukopenia). The first part of this study was designed to determine the acute grade 3/4 toxicity rate (excluding grade 3 leukopenia), to have a starting point for the second part (second arm) of the study. |
| Primary | Number of Patients With Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia) | From start of treatment to 90 days | The second part of this study (second arm) was designed to detect a 40% relative reduction (absolute from 77% to 46%) in the acute grade 3/4 toxicity (excluding grade 3 leukopenia) rate, with the addition of amifostine. A one-sided alpha of 0.05 and 80% power required 16 evaluable patients to detect the hypothesized difference. If ≤ 8 had the toxicity, it would be concluded that adding amifostine decreased this toxicity rate by at least 40%. |
| Secondary | Pelvic Tumor Control | From registration to date of pelvic tumor failure or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. | |
| Secondary | Distant Metastases | From registration to date of distant mets or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. |
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 | Rate of Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia) | From start of treatment to 90 days | All eligible patients | percentage of participants | NUMBER |
| PRIMARY | Number of Patients With Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia) | From start of treatment to 90 days | All eligible patients | participants | NUMBER |
| SECONDARY | Pelvic Tumor Control | From registration to date of pelvic tumor failure or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. | |||
| SECONDARY | Distant Metastases | From registration to date of distant mets or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia) | Radiation Therapy Plus Cisplatin | 81 | 95% Confidence Interval 66 to 96 | percentage of participants | |
| Number of Patients With Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia) | Radiation Therapy Plus Cisplatin and Amifostine | 13 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Radiation Therapy Plus Cisplatin | 27 | |
| Overall Study | STARTED | Radiation Therapy Plus Cisplatin & Amifostine | 18 | |
| Overall Study | COMPLETED | Radiation Therapy Plus Cisplatin | 26 | |
| Overall Study | COMPLETED | Radiation Therapy Plus Cisplatin & Amifostine | 15 | |
| Overall Study | NOT COMPLETED | Radiation Therapy Plus Cisplatin | 1 | |
| Overall Study | NOT COMPLETED | Radiation Therapy Plus Cisplatin & Amifostine | 3 |
Source ClinicalTrials.gov
Adverse events140
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 | Hemoglobin decreased | Blood and lymphatic system disorders | Radiation Therapy Plus Cisplatin | 24 | 26 | |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Radiation Therapy Plus Cisplatin & Amifostine | 15 | 15 | |
| other | Hearing-Other | Ear and labyrinth disorders | Radiation Therapy Plus Cisplatin | 2 | 26 | |
| other | Hearing-Other | Ear and labyrinth disorders | Radiation Therapy Plus Cisplatin & Amifostine | 2 | 15 | |
| other | Abdominal pain NOS | Gastrointestinal disorders | Radiation Therapy Plus Cisplatin | 4 | 26 | |
| other | Abdominal pain NOS | Gastrointestinal disorders | Radiation Therapy Plus Cisplatin & Amifostine | 1 | 15 | |
| other | Constipation | Gastrointestinal disorders | Radiation Therapy Plus Cisplatin | 8 | 26 | |
| other | Constipation | Gastrointestinal disorders | Radiation Therapy Plus Cisplatin & Amifostine | 5 | 15 | |
| other | Diarrhea NOS | Gastrointestinal disorders | Radiation Therapy Plus Cisplatin | 15 | 26 | |
| other | Diarrhea NOS | Gastrointestinal disorders | Radiation Therapy Plus Cisplatin & Amifostine | 14 | 15 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Radiation Therapy Plus Cisplatin | ||
| Total, all-cause mortality | Radiation Therapy Plus Cisplatin & Amifostine | ||
| Total, other adverse events | Radiation Therapy Plus Cisplatin | 26 | 26 |
| Total, other adverse events | Radiation Therapy Plus Cisplatin & Amifostine | 15 | 15 |
| Total, serious adverse events | Radiation Therapy Plus Cisplatin | 20 | 26 |
| Total, serious adverse events | Radiation Therapy Plus Cisplatin & Amifostine | 12 | 15 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Radiation Therapy Plus Cisplatin vs Radiation Therapy Plus Cisplatin & Amifostine: 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/NCT00012012
GET https://conductscience.org/api/trials/v1/NCT00012012/events?page=2