NCT00113399 · STUDY IN CONTEXT

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. 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

Overall Survival

This study terminated early with 15 subjects out of 240 subjects accrued, therefore no analyses were performed.

→

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-malignant-head-and-neck-neoplasm
nct id: NCT00113399
trial label: Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
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: 1
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00113399
outcome key
om-0000
source section id
NCT00113399-om-0000
source outcome index
0
endpoint
Overall Survival
endpoint definition
Overall Survival
time origin
Date of death or last follow-up
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
This study terminated early with 15 subjects out of 240 subjects accrued, therefore no analyses were performed.
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-malignant-head-and-neck-neoplasm
nct id
NCT00113399
outcome key
om-0000
arm key
OG000
arm label
Re-irradiation Plus Concurrent Chemotherapy
regimen
Radiation Therapy on weeks 1, 3, 5, and 7 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00113399-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00113399
outcome key
om-0000
arm key
OG001
arm label
Chemotherapy Alone
regimen
Select from one of the three standard chemotherapy regimens: cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00113399-om-0000#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00113399
harm key
EG000
source section id
NCT00113399-ae
event group key
EG000
event group label
Re-irradiation Plus Concurrent Chemotherapy
serious affected
4
serious at risk
6
other affected
6
other at risk
6
frequency threshold
0
collection period
Source null
event definition
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
undenominated note
Source null
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-malignant-head-and-neck-neoplasm
nct id
NCT00113399
harm key
EG001
source section id
NCT00113399-ae
event group key
EG001
event group label
Chemotherapy Alone
serious affected
4
serious at risk
7
other affected
6
other at risk
7
frequency threshold
0
collection period
Source null
event definition
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
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