Trial · NCT00274937
Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
NCT00274937, Phase 3, Completed, Children's Oncology Group; results first posted 2017-01-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer. Trials, record NCT00274937. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00274937
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
- NCT number
- NCT00274937
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 111 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
Stage I Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, Stage I Nasopharyngeal Undifferentiated Carcinoma AJCC v7, Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, Stage II Nasopharyngeal Undifferentiated Carcinoma AJCC v7, Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, Stage III Nasopharyngeal Undifferentiated Carcinoma AJCC v7, Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7
- Interventions
- Amifostine, Cisplatin, Fluorouracil, Laboratory Biomarker Analysis, Radiation Therapy
- First posted
- 2006-01-11
- Last updated
- 2022-10-25
- Results first posted
- 2017-01-19
- Limitations and caveats
- Data was and never will never be collected for Outcome Measure #2 and Outcome Measure #3. Funding was not obtained and results will never be reported for Outcome Measure #4.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Two Year Event-free Survival (EFS) | Up to Two Year After Enrollment | The two-year event-free survival will be compared with a standard established from adult oncology data and the results of POG-9486. The two-year Kaplan-Meier estimate of event-free survival will be compared with 70% using a 1-sided test of size 0.05 using the asymptotic distribution of the complementary log-log distribution of the estimate. |
| Secondary | Predictive Value of Epstein-Barr Virus (EBV) DNA as Measured by Quantitative Detection at Enrollment on EFS 2 Years After Treatment | At study enrollment | Presence of EBV DNA in serum. |
| Secondary | Prognostic Significance of EBV Viral Load | At study enrollment | Viral load in blood. |
| Secondary | Predictive Value of the Detection of EBV DNA in the Peripheral Blood | Up to 6 years | The prognostic value of the presence of EBV DNA will be assessed using the log-rank test, adjusted by initial stage of disease, if appropriate. The proposed analysis will take place at the analytic endpoint of the clinical trial. |
| Secondary | Protective Effects of Amifostine Assessed Primarily by Sialometry | At study enrollment | Weight of stimulated saliva production in grams. |
| Secondary | Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams. | At study enrollment | Weight of unstimulated saliva production in grams. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Two Year Event-free Survival (EFS) | Up to Two Year After Enrollment | No patients were enrolled to Stratum 1. | Estimated probability | NUMBER |
| SECONDARY | Predictive Value of Epstein-Barr Virus (EBV) DNA as Measured by Quantitative Detection at Enrollment on EFS 2 Years After Treatment | At study enrollment | Data was and never will be collected. | ||
| SECONDARY | Prognostic Significance of EBV Viral Load | At study enrollment | Data was and never will be collected. | ||
| SECONDARY | Predictive Value of the Detection of EBV DNA in the Peripheral Blood | Up to 6 years | Funding was not obtained and results will never be reported. | ||
| SECONDARY | Protective Effects of Amifostine Assessed Primarily by Sialometry | At study enrollment | Twenty-six patients in stratum 2 were evaluated at both study enrollment and at the end of consolidation for the weight of stimulated saliva production. This outcome measure was only collected for patients in Stratum 2. | Grams of saliva | MEAN |
| SECONDARY | Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams. | At study enrollment | Twenty-nine patients in stratum 2 were evaluated at both study enrollment and at the end of consolidation for the weight of unstimulated saliva production. This outcome measure was only collected for patients in Stratum 2. | Grams of saliva | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Two Year Event-free Survival (EFS) | Stratum II | 0.87 | 95% Confidence Interval 0.79 to 0.92 | Estimated probability | |
| Protective Effects of Amifostine Assessed Primarily by Sialometry | Stratum II | At study Enrollment | 4.97 | Standard Deviation 5.44 | Grams of saliva |
| Protective Effects of Amifostine Assessed Primarily by Sialometry | Stratum II | At end of consolidation | 3.39 | Standard Deviation 4.71 | Grams of saliva |
| Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams. | Stratum II | At study Enrollment | 3.37 | Standard Deviation 4.49 | Grams of saliva |
| Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams. | Stratum II | At end of consolidation | 2.30 | Standard Deviation 3.90 | Grams of saliva |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stratum II | 111 | |
| Overall Study | COMPLETED | Stratum II | 91 | |
| Overall Study | NOT COMPLETED | Stratum II | 20 |
Source ClinicalTrials.gov
Adverse events115
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 | Constipation | Gastrointestinal disorders | Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy) | 1 | 111 | |
| other | Diarrhea | Gastrointestinal disorders | Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy) | 1 | 111 | |
| other | Dizziness | Nervous system disorders | Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy) | 1 | 111 | |
| other | Dysgeusia | Nervous system disorders | Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy) | 1 | 111 | |
| other | Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy) | 1 | 111 | |
| other | Ear pain | Ear and labyrinth disorders | Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy) | 1 | 111 | |
| other | Esophageal pain | Gastrointestinal disorders | Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy) | 1 | 111 | |
| other | Fever | General disorders | Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy) | 3 | 111 | |
| other | Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy) | 1 | 111 | |
| other | Headache | Nervous system disorders | Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy) | 1 | 111 |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy) | ||
| Total, other adverse events | Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy) | 36 | 111 |
| Total, serious adverse events | Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy) | 79 | 111 |
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 |
|---|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 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/NCT00274937
GET https://conductscience.org/api/trials/v1/NCT00274937/events?page=2