Skip to content
Triangle logo TriangleGet started
← locally advanced Oropharyngeal Cancer

NCT00895245 · STUDY IN CONTEXT

Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone in Preventing Nausea and Vomiting Caused by Cisplatin in Patients With Stage III or Stage IV Head and Neck

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced 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

Complete response is defined as no emesis or rescue nausea medications needed in the first 120 hours following cisplatin infusion.

Source null

→

secondary · POSTED

Rate of Complete Response to Anti-emetic Therapy in the Delayed Setting (25-120 Hours After Cisplatin Infusion)

Source null

→

secondary · POSTED

The visual analog scale ranges from 0-100. 0 is labeled as "no nausea" and 100 is labeled as "nausea as bad as it could be" A score of \< 25 is considered to indicate no significant nausea. All patients discontinued trial after only one cisplatin infusion.

Source null

→

secondary · POSTED

FLIE is a patient-completed quality of life assessment modified from the original Functional Living Index - Cancer questionnaire. FLIE contains two domains: nausea and vomiting with nine items in each domain. The first item asks the patient to rate how much nausea (or vomiting) has occurred over a 5 day period. The remaining eight items ask patients to rate the impact of nausea (or vomiting) on various aspects of a patient's life (for example, ability to enjoy meals/liquids). Each item is answered using a 7 point visual analog scale with 7 being "none /not at all" and 1 being "a great deal". The two domains are summed for a total score with a possible range of 18-126. Higher scores indicate a more favorable quality of life. A total score of \>108 defines those patients who had a minimal impact of CINV on quality of life. All particpants discontinued the trial after one cycle of cisplatin.

Two patients did not complete the Functional Living Index-Emesis (FLIE) Questionnaire.

→

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

Unnamed quality-of-life measure · Impact of Cisplatin-induced Nausea and Vomiting on Daily Life During the 5 Day Period Following Cisplatin Infusion for Multiple Cycles as Measured by the Functional Living Index-Emesis Questionnaire

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
nct id
NCT00895245
qol key
qol-0003
source section id
NCT00895245-om-0003
source outcome index
3
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Impact of Cisplatin-induced Nausea and Vomiting on Daily Life During the 5 Day Period Following Cisplatin Infusion for Multiple Cycles as Measured by the Functional Living Index-Emesis Questionnaire
measure definition
FLIE is a patient-completed quality of life assessment modified from the original Functional Living Index - Cancer questionnaire. FLIE contains two domains: nausea and vomiting with nine items in each domain. The first item asks the patient to rate how much nausea (or vomiting) has occurred over a 5 day period. The remaining eight items ask patients to rate the impact of nausea (or vomiting) on various aspects of a patient's life (for example, ability to enjoy meals/liquids). Each item is answered using a 7 point visual analog scale with 7 being "none /not at all" and 1 being "a great deal". The two domains are summed for a total score with a possible range of 18-126. Higher scores indicate a more favorable quality of life. A total score of \>108 defines those patients who had a minimal impact of CINV on quality of life. All particpants discontinued the trial after one cycle of cisplatin.
time frame
5 days following cisplatin infusion
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Two patients did not complete the Functional Living Index-Emesis (FLIE) Questionnaire.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
nct id
NCT00895245
trial label
Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone in Preventing Nausea and Vomiting Caused by Cisplatin in Patients With Stage III or Stage IV Head and Neck
applicability
unclear
applicability note
Attached because the study's own record describes locally advanced 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
4
harms Count
1
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT00895245
    outcome key
    om-0000
    source section id
    NCT00895245-om-0000
    source outcome index
    0
    endpoint
    Proportion of Patients With a Complete Response to the Anti-emetic Medication Regimen
    endpoint definition
    Complete response is defined as no emesis or rescue nausea medications needed in the first 120 hours following cisplatin infusion.
    time origin
    120 hours following cisplatin infusion
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT00895245
    outcome key
    om-0001
    source section id
    NCT00895245-om-0001
    source outcome index
    1
    endpoint
    Rate of Complete Response to Anti-emetic Therapy in the Delayed Setting (25-120 Hours After Cisplatin Infusion)
    endpoint definition
    Rate of Complete Response to Anti-emetic Therapy in the Delayed Setting (25-120 Hours After Cisplatin Infusion)
    time origin
    25-120 hours following cisplatin infusion
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT00895245
    outcome key
    om-0002
    source section id
    NCT00895245-om-0002
    source outcome index
    2
    endpoint
    Control of Nausea for 120 Hours Following Each Cisplatin Infusion for Multiple Cycles of Therapy as Measured by the Visual Analog Scale
    endpoint definition
    The visual analog scale ranges from 0-100. 0 is labeled as "no nausea" and 100 is labeled as "nausea as bad as it could be" A score of \< 25 is considered to indicate no significant nausea. All patients discontinued trial after only one cisplatin infusion.
    time origin
    120 hours following cisplatin infusion
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT00895245
    outcome key
    om-0003
    source section id
    NCT00895245-om-0003
    source outcome index
    3
    endpoint
    Impact of Cisplatin-induced Nausea and Vomiting on Daily Life During the 5 Day Period Following Cisplatin Infusion for Multiple Cycles as Measured by the Functional Living Index-Emesis Questionnaire
    endpoint definition
    FLIE is a patient-completed quality of life assessment modified from the original Functional Living Index - Cancer questionnaire. FLIE contains two domains: nausea and vomiting with nine items in each domain. The first item asks the patient to rate how much nausea (or vomiting) has occurred over a 5 day period. The remaining eight items ask patients to rate the impact of nausea (or vomiting) on various aspects of a patient's life (for example, ability to enjoy meals/liquids). Each item is answered using a 7 point visual analog scale with 7 being "none /not at all" and 1 being "a great deal". The two domains are summed for a total score with a possible range of 18-126. Higher scores indicate a more favorable quality of life. A total score of \>108 defines those patients who had a minimal impact of CINV on quality of life. All particpants discontinued the trial after one cycle of cisplatin.
    time origin
    5 days following cisplatin infusion
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Two patients did not complete the Functional Living Index-Emesis (FLIE) Questionnaire.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT00895245
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I
    regimen
    Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks. Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin. Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion. fosaprepitant dimeglumine: Given IV cisplatin: Given IV palonosetron hydrochloride: Given IV dexamethasone: Given IV and orally Functional Living Index-Emesis Questionnaire: Ancillary studies Emesis Diary: Ancillary studies Radiotherapy: Undergo r
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00895245-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT00895245
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I
    regimen
    Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks. Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin. Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion. fosaprepitant dimeglumine: Given IV cisplatin: Given IV palonosetron hydrochloride: Given IV dexamethasone: Given IV and orally Functional Living Index-Emesis Questionnaire: Ancillary studies Emesis Diary: Ancillary studies Radiotherapy: Undergo r
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00895245-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT00895245
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm I
    regimen
    Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks. Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin. Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion. fosaprepitant dimeglumine: Given IV cisplatin: Given IV palonosetron hydrochloride: Given IV dexamethasone: Given IV and orally Functional Living Index-Emesis Questionnaire: Ancillary studies Emesis Diary: Ancillary studies Radiotherapy: Undergo r
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00895245-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT00895245
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm I
    regimen
    Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks. Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin. Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion. fosaprepitant dimeglumine: Given IV cisplatin: Given IV palonosetron hydrochloride: Given IV dexamethasone: Given IV and orally Functional Living Index-Emesis Questionnaire: Ancillary studies Emesis Diary: Ancillary studies Radiotherapy: Undergo r
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00895245-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT00895245
    harm key
    EG000
    source section id
    NCT00895245-ae
    event group key
    EG000
    event group label
    Arm I
    serious affected
    0
    serious at risk
    6
    other affected
    6
    other at risk
    6
    frequency threshold
    0
    collection period
    up to 7 weeks
    event definition
    Only grade 2 and higher adverse events were recorded.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT00895245
    qol key
    qol-0003
    source section id
    NCT00895245-om-0003
    source outcome index
    3
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Impact of Cisplatin-induced Nausea and Vomiting on Daily Life During the 5 Day Period Following Cisplatin Infusion for Multiple Cycles as Measured by the Functional Living Index-Emesis Questionnaire
    measure definition
    FLIE is a patient-completed quality of life assessment modified from the original Functional Living Index - Cancer questionnaire. FLIE contains two domains: nausea and vomiting with nine items in each domain. The first item asks the patient to rate how much nausea (or vomiting) has occurred over a 5 day period. The remaining eight items ask patients to rate the impact of nausea (or vomiting) on various aspects of a patient's life (for example, ability to enjoy meals/liquids). Each item is answered using a 7 point visual analog scale with 7 being "none /not at all" and 1 being "a great deal". The two domains are summed for a total score with a possible range of 18-126. Higher scores indicate a more favorable quality of life. A total score of \>108 defines those patients who had a minimal impact of CINV on quality of life. All particpants discontinued the trial after one cycle of cisplatin.
    time frame
    5 days following cisplatin infusion
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Two patients did not complete the Functional Living Index-Emesis (FLIE) Questionnaire.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice