Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

No patients were enrolled to Stratum 1.

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secondary · POSTED

Presence of EBV DNA in serum.

Data was and never will be collected.

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secondary · POSTED

Viral load in blood.

Data was and never will be collected.

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secondary · POSTED

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.

Funding was not obtained and results will never be reported.

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secondary · POSTED

Weight of stimulated saliva production in grams.

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.

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secondary · POSTED

Weight of unstimulated saliva production in grams.

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.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id: NCT00274937
trial label: Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT00274937
outcome key
om-0000
source section id
NCT00274937-om-0000
source outcome index
0
endpoint
Two Year Event-free Survival (EFS)
endpoint definition
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.
time origin
Up to Two Year After Enrollment
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
No patients were enrolled to Stratum 1.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT00274937
outcome key
om-0001
source section id
NCT00274937-om-0001
source outcome index
1
endpoint
Predictive Value of Epstein-Barr Virus (EBV) DNA as Measured by Quantitative Detection at Enrollment on EFS 2 Years After Treatment
endpoint definition
Presence of EBV DNA in serum.
time origin
At study enrollment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Data was and never will be collected.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT00274937
outcome key
om-0002
source section id
NCT00274937-om-0002
source outcome index
2
endpoint
Prognostic Significance of EBV Viral Load
endpoint definition
Viral load in blood.
time origin
At study enrollment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Data was and never will be collected.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT00274937
outcome key
om-0003
source section id
NCT00274937-om-0003
source outcome index
3
endpoint
Predictive Value of the Detection of EBV DNA in the Peripheral Blood
endpoint definition
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.
time origin
Up to 6 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Funding was not obtained and results will never be reported.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT00274937
outcome key
om-0004
source section id
NCT00274937-om-0004
source outcome index
4
endpoint
Protective Effects of Amifostine Assessed Primarily by Sialometry
endpoint definition
Weight of stimulated saliva production in grams.
time origin
At study enrollment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT00274937
outcome key
om-0005
source section id
NCT00274937-om-0005
source outcome index
5
endpoint
Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams.
endpoint definition
Weight of unstimulated saliva production in grams.
time origin
At study enrollment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT00274937
outcome key
om-0000
arm key
OG000
arm label
Stratum II
regimen
AJCC Stage IIb - IV
analyzed count
111
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00274937-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT00274937
outcome key
om-0001
arm key
OG000
arm label
Stratum II
regimen
AJCC Stage IIb - IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00274937-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT00274937
outcome key
om-0002
arm key
OG000
arm label
Stratum II
regimen
AJCC Stage IIb - IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00274937-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT00274937
outcome key
om-0003
arm key
OG000
arm label
Stratum II
regimen
AJCC Stage IIb - IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00274937-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT00274937
outcome key
om-0004
arm key
OG000
arm label
Stratum II
regimen
AJCC Stage IIb - IV
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00274937-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT00274937
outcome key
om-0005
arm key
OG000
arm label
Stratum II
regimen
AJCC Stage IIb - IV
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00274937-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT00274937
harm key
EG000
source section id
NCT00274937-ae
event group key
EG000
event group label
Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy)
serious affected
79
serious at risk
111
other affected
36
other at risk
111
frequency threshold
0
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice