Skip to content
Triangle logo TriangleGet started
← Study library

NCT00352118 · REGISTRY CONDITION SEARCH

Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2017-12-28

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with locally advanced head and neck cancer. The doctor also wants to find out if patients who receive this treatment need a feeding tube 1 year after starting treatment.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Number of Patients With Feeding Tube Dependency

→

outcome · POSTED

Number of Days With Progression-free Survival

→

outcome · POSTED

Number of Days - Overall Survival

→

outcome · POSTED

Number of Days With Disease Free Survival

→

outcome · POSTED

Time to Treatment Failure

→

outcome · POSTED

Swallowing Ability - Quality of Life Scores

→

outcome · POSTED

Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically confirmed squamous cell carcinoma of the head and neck * Stage IVA or IVB disease * Stage III disease allowed provided patient may benefit from organ preservation or patient refused surgery * Measurable or evaluable disease * ECOG performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine ≤ 1.5 mg/dL OR glomerular filtration rate ≥ 60 mL/min * Bilirubin normal * Alkaline phosphatase (AP) and AST or ALT must be within the following ranges: * AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN) * AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN * AP ≤ 5 times ULN AND AST or ALT normal Exclusion Criteria: * Salivary gland, sinus, or nasopharyngeal primary disease * Evidence of distant metastatic disease * Pregnant or nursing * Positive pregnancy test (Fertile patients must use effective contraception during study treatment and for 3 months after completion of study treatment) * Other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancy in which stage and nature of disease is such that it is unlikely to affect survival for the next 3 years * Peripheral neuropathy ≥ grade 2 * Hearing loss ≥ grade 2 * Severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 and/or cisplatin or other platinum analogs * Poor nutritional status, in the opinion of the investigator * Active infection * Active ischemic heart disease * Myocardial infarction within the past 6 months * Prior radiotherapy above the clavicles * Prior chemotherapy * Prior surgery to the primary tumor except biopsy * Concurrent amifostine or other investigational agents
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.
    intervention Names
    1. Biological: filgrastim
    2. Biological: pegfilgrastim
    3. Drug: cisplatin
    4. Drug: docetaxel
    5. Drug: fluorouracil
    6. Procedure: conventional surgery
    7. Radiation: radiation therapy
    label
    Chemotherapy + Low Dose Radiation
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Chemotherapy + Low Dose Radiation
    description
    subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses.
    name
    filgrastim
    other Names
    1. G-CSF
    2. Neupogen
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Chemotherapy + Low Dose Radiation
    description
    If applicable on day 5, repeating every 3 weeks for 2 courses.
    name
    pegfilgrastim
    other Names
    1. Neulasta, G-CSF
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Chemotherapy + Low Dose Radiation
    description
    Intravenous over 1 hour on day 1, every 3 weeks for 3 courses.
    name
    cisplatin
    other Names
    1. CDDP
    2. cisplatinum
    3. cis-diamminedichloridoplatinum
    4. Platinol AQ
    type
    DRUG
  4. arm Group Labels
    1. Chemotherapy + Low Dose Radiation
    description
    Intravenous over 1 hour on day 1.
    name
    docetaxel
    other Names
    1. Taxotere(R)
    type
    DRUG
  5. arm Group Labels
    1. Chemotherapy + Low Dose Radiation
    description
    Intravenous continuously on days 1-4.
    name
    fluorouracil
    other Names
    1. 5-FU
    2. 5-fluorouracil
    3. Adrucil
    type
    DRUG
  6. arm Group Labels
    1. Chemotherapy + Low Dose Radiation
    description
    As appropriate, neck dissection.
    name
    conventional surgery
    other Names
    1. surgery
    type
    PROCEDURE
  7. arm Group Labels
    1. Chemotherapy + Low Dose Radiation
    description
    60 Gy 5 days/week x 6 weeks with cisplatin
    name
    radiation therapy
    other Names
    1. radiation
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
4
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    All patients were non-evaluable and study was terminated early. There is no measure of outcome.
    measure
    Number of Patients With Feeding Tube Dependency
    time Frame
    at 12 months
secondary Outcomes
  1. description
    All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.
    measure
    Number of Days With Progression-free Survival
    time Frame
    Between date of registration to date of first treatment failure or death.
  2. description
    All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.
    measure
    Number of Days - Overall Survival
    time Frame
    Between date of registration to date of death.
  3. description
    All patients were non-evaluable and study was terminated early. There is no measure of outcome. RECIST criteria measurement.
    measure
    Number of Days With Disease Free Survival
    time Frame
    From Date of Registration to Date of First Treatment Failure or Death
  4. description
    All patients were non-evaluable and study was terminated early. There is no measure of outcome. Measure using RECIST criteria.
    measure
    Time to Treatment Failure
    time Frame
    Number of Days from Complete or Partial Response to First Date of Recurrence or Progression
  5. description
    All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing Swallowing Portion of ASHA Functional Communication Measure for Swallowing (FCM) and Dysphagia Outcome and Severity Scale (DOSS).
    measure
    Swallowing Ability - Quality of Life Scores
    time Frame
    Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.
  6. description
    All patients were non-evaluable and study was terminated early. There is no measure of outcome.
    measure
    Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire
    time Frame
    baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with locally advanced head and neck cancer. The doctor also wants to find out if patients who receive this treatment need a feeding tube 1 year after starting treatment.
detailed Description
OBJECTIVES: Primary * Determine feeding tube dependency at 12 months in patients with locally advanced head and neck cancer treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by cisplatin and reduced-dose radiotherapy. Secondary * Determine the progression-free, disease-free, and overall survival of patients treated with this regimen. * Determine the pattern of failure in patients treated with this regimen. * Evaluate the quality of life of patients treated with this regimen. * Assess pre- and post-treatment swallowing ability of patients and the impact on their quality of life. Tertiary * Quantify salivary flow rates of patients receiving chemotherapy with radiotherapy for head and neck malignancy. * Evaluate the quality of saliva by examining total protein concentrations. * Quantify proangiogenic cytokines (interleukin \[IL\]-1, IL-6, IL-8, and vascular endothelial growth factor) in the saliva of these patients. * Determine the degree of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy. * Compare salivary flow rates with the grade of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy. OUTLINE: This is a pilot study. * Induction therapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 followed by fluorouracil IV continuously on days 1- 4. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 5-14 or pegfilgrastim SC on day 5. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a partial or clinical complete response proceed to chemoradiotherapy 3 weeks later. * Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent reduced-dose radiotherapy 5 days a week for 6 weeks. * Surgery: Approximately 6 to 8 weeks after completing chemoradiotherapy, patients with residual neck disease or disease initially staged at N2 or greater undergo neck dissection. Saliva is collected periodically to measure flow rates and quality; quantify proangiogenic cytokines (interleukin \[IL\]-1, IL-6, IL-8 and vascular endothelial growth factor); and examine the grade of mucositis and xerostomia. Quality of life is assessed at baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year. After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-6a8288e5a7a2c327d17e
      requested nct id
      NCT00352118
      primary nct id
      NCT00352118
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
      payload sha256
      fbeaaee5980e787a90f1c5b4cf486826e2c56a75cf361ce41dcdba3aed066c52
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-6a8288e5a7a2c327d17e
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00352118
      occurrences
      1. context exact
        NCT00352118
        end
        11
        exact text
        NCT00352118
        start
        0
      offset unit
      unicode_code_points
      query cond
      Laryngeal Cancer
      query disease state id
      ds-laryngeal-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-laryngeal-cancer-000.json
      source file sha256
      fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
      source json pointer
      /studies/49/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      55f1baec0ad9e681a90230e1fc9a045489b2d3728c69e987b25a077203c5ac10
    2. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-9e08226d950bef122034
      requested nct id
      NCT00352118
      primary nct id
      NCT00352118
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      38e97f6c23d7b292911d062dea3fc0dffbdcbde03aae232fe8d067fdd28034c9
      payload sha256
      7b2196ce296ff21235aba63a8ff3a3046ed8a3c66222482819ffec66aa4bc615
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-9e08226d950bef122034
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00352118
      occurrences
      1. context exact
        NCT00352118
        end
        11
        exact text
        NCT00352118
        start
        0
      offset unit
      unicode_code_points
      query cond
      Salivary Gland Cancer
      query disease state id
      ds-salivary-gland-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-salivary-gland-cancer-000.json
      source file sha256
      38e97f6c23d7b292911d062dea3fc0dffbdcbde03aae232fe8d067fdd28034c9
      source json pointer
      /studies/24/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      55f1baec0ad9e681a90230e1fc9a045489b2d3728c69e987b25a077203c5ac10
    3. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-d36f7462d4f54d806f39
      requested nct id
      NCT00352118
      primary nct id
      NCT00352118
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      cd92c144c33b33e75a38086ce6cbd6e62d34b7ba84c72dacac16e6781439e40e
      payload sha256
      e000b600e7070f491b4509d8c526b35119efc5e5702c214be4fd03011920cfbb
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-d36f7462d4f54d806f39
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00352118
      occurrences
      1. context exact
        NCT00352118
        end
        11
        exact text
        NCT00352118
        start
        0
      offset unit
      unicode_code_points
      query cond
      Hypopharyngeal Cancer
      query disease state id
      ds-hypopharyngeal-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-hypopharyngeal-cancer-000.json
      source file sha256
      cd92c144c33b33e75a38086ce6cbd6e62d34b7ba84c72dacac16e6781439e40e
      source json pointer
      /studies/37/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      55f1baec0ad9e681a90230e1fc9a045489b2d3728c69e987b25a077203c5ac10

    Preserved source evidence · Not medical advice