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NCT03174275 · STUDY IN CONTEXT

Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma

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

The pCRR was assessed via surgical pathology report. Pathologic complete response will require no viable cancer cells on the surgical pathology report after neoadjuvant treatment with carboplatin, nab-paclitaxel, and durvalumab. This study protocol requires the same neoadjuvant therapy and surgery for all subjects. The primary outcome measure is the complete pathologic response defined by the surgical pathology report and is unrelated to adjuvant therapy.

Subjects received treatment in 4 cancer centers in the United States.

→

secondary · NOT_POSTED

Clinical complete response rate and clinical response rate (CR + PR) associated with induction chemotherapy will be estimated using RECIST 1.1.

Source null

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secondary · NOT_POSTED

Risk level pre-induction will be based on physical examination and imaging and will be defined and documented in electronic Case Report Forms (eCRF) prior to the initiation of induction therapy. Post-induction risk level will be determined based on pathologic evaluation of surgical specimen.

Source null

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secondary · NOT_POSTED

PFS will be defined as the time from day 1 of study treatment until progression per RECIST 1.1

Source null

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secondary · NOT_POSTED

Overall survival will be defined as the time from day 1 of study treatment until death from any cause

Source null

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secondary · NOT_POSTED

Safety associated with both induction alone and with 3 part therapy consisting of induction chemotherapy, surgery and risk-adapted use of chemoradiation will be assessed via the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03)

Source null

→

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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
nct id
NCT03174275
trial label
Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma
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
6
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT03174275
    outcome key
    om-0000
    source section id
    NCT03174275-om-0000
    source outcome index
    0
    endpoint
    Pathologic Complete Response Rate (pCRR) After Induction Chemotherapy With Carboplatin, Nab-paclitaxel, and Durvalumab in Previously Untreated Stage III and IV SCCHN Amenable to Surgical Resection
    endpoint definition
    The pCRR was assessed via surgical pathology report. Pathologic complete response will require no viable cancer cells on the surgical pathology report after neoadjuvant treatment with carboplatin, nab-paclitaxel, and durvalumab. This study protocol requires the same neoadjuvant therapy and surgery for all subjects. The primary outcome measure is the complete pathologic response defined by the surgical pathology report and is unrelated to adjuvant therapy.
    time origin
    After surgery (approximately 8-12 weeks after start of study treatment)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Subjects received treatment in 4 cancer centers in the United States.
    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
    NCT03174275
    outcome key
    om-0001
    source section id
    NCT03174275-om-0001
    source outcome index
    1
    endpoint
    Clinical Complete Response Rate and (cCRR) and Clinical Response Rate (cRR) Following Induction Chemotherapy
    endpoint definition
    Clinical complete response rate and clinical response rate (CR + PR) associated with induction chemotherapy will be estimated using RECIST 1.1.
    time origin
    1-4 weeks post induction chemotherapy
    analysis role
    secondary
    reporting status
    NOT_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
    NCT03174275
    outcome key
    om-0002
    source section id
    NCT03174275-om-0002
    source outcome index
    2
    endpoint
    Percent of Patients Who Have a Change in Estimated Risk Level
    endpoint definition
    Risk level pre-induction will be based on physical examination and imaging and will be defined and documented in electronic Case Report Forms (eCRF) prior to the initiation of induction therapy. Post-induction risk level will be determined based on pathologic evaluation of surgical specimen.
    time origin
    After surgery (approximately 8-12 weeks after start of study treatment)
    analysis role
    secondary
    reporting status
    NOT_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
    NCT03174275
    outcome key
    om-0003
    source section id
    NCT03174275-om-0003
    source outcome index
    3
    endpoint
    Progression Free Survival (PFS) Associated With 3 Part Therapy Consisting of Induction Chemotherapy, Surgery and Risk-adapted Use of Chemoradiation
    endpoint definition
    PFS will be defined as the time from day 1 of study treatment until progression per RECIST 1.1
    time origin
    5 years
    analysis role
    secondary
    reporting status
    NOT_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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT03174275
    outcome key
    om-0004
    source section id
    NCT03174275-om-0004
    source outcome index
    4
    endpoint
    Overall Survival (OS) Associated With 3 Part Therapy Consisting of Induction Chemotherapy, Surgery and Risk-adapted Use of Chemoradiation
    endpoint definition
    Overall survival will be defined as the time from day 1 of study treatment until death from any cause
    time origin
    5 years
    analysis role
    secondary
    reporting status
    NOT_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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT03174275
    outcome key
    om-0005
    source section id
    NCT03174275-om-0005
    source outcome index
    5
    endpoint
    Toxicity Profile Associated With Both Induction Therapy and Total 3 Part Therapy Consisting of Induction Chemotherapy, Surgery and Risk-adapted Use of Chemoradiation
    endpoint definition
    Safety associated with both induction alone and with 3 part therapy consisting of induction chemotherapy, surgery and risk-adapted use of chemoradiation will be assessed via the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03)
    time origin
    90 days after the last dose of study treatment
    analysis role
    secondary
    reporting status
    NOT_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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT03174275
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Pathologic Complete Response
    regimen
    All subjects received neoadjuvant chemotherapy and underwent surgery, and histopathological analyses were completed.
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03174275-om-0000#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT03174275
    harm key
    EG000
    source section id
    NCT03174275-ae
    event group key
    EG000
    event group label
    All Subjects
    serious affected
    9
    serious at risk
    39
    other affected
    38
    other at risk
    39
    frequency threshold
    0
    collection period
    Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months.
    event definition
    CTCAEv4
    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