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NCT00117572 · REGISTRY CONDITION SEARCH

Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)

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

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2018-04-09

The combined use of chemotherapeutic drugs with radiation has proven to be effective in improving overall survival and local control among patients with locally advanced head and neck cancer. Induction chemotherapy given before receiving local treatment has been shown to reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from growing or dividing, although it has yet to be determined which agent, or specific combination of agents, is most effective in treating head and neck cancer. Docetaxel is a drug which has been reported to show promising activity in Phase II head and neck cancer studies. Therefore, the purpose of this trial is to compare the effectiveness of induction chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in patients with locally advanced head and neck cancer.

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

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baseline

Baseline characteristics

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outcome · POSTED

Overall Survival: Time From Randomization to Death From Any Cause

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outcome · POSTED

Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause

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outcome · POSTED

Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause

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outcome · POSTED

Failure Pattern (Local/Regional Recurrence)

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outcome · POSTED

Failure Pattern (Distant Recurrence)

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outcome · POSTED

Quality of Life (FACT H&N)

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outcome · POSTED

Quality of Life (Normalcy of Diet)

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outcome · POSTED

Quality of Life (Speech)

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outcome · POSTED

Quality of Life (McMaster)

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outcome · POSTED

Quality of Life (FACT H&N)

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outcome · POSTED

Quality of Life (Normalcy of Diet)

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outcome · POSTED

Quality of Life (Speech)

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outcome · POSTED

Quality of Life (McMaster)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Age 18 years or older * Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas of the head and neck (excluding lip), or lymphoepithelioma * No prior chemotherapy or radiotherapy * Prior surgical therapy will consist only of incisional or excisional biopsy, and organ sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an existing primary tumor * Karnofsky performance status of \>= 70% * Intact organ and bone marrow function * Obtained informed consent Exclusion Criteria: * Demonstration of metastatic disease (i.e. M1 disease). * Patients with a history of severe allergic reaction to docetaxel or other drugs formulated with polysorbate 80. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, 5-fluorouracil, or hydroxyurea * Other coexisting malignancies or malignancies diagnosed within the previous 3 years with the exception of basal cell carcinoma, cervical cancer in situ, and other treated malignancies with no evidence of disease for at least 3 years. * Prior surgical therapy other than incisional or excisional biopsy and organ-sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an unknown primary tumor. Any non-biopsy procedure must have taken place less than 3 months from initiating protocol treatment. * Incomplete healing from previous surgery * Pregnancy or breast feeding (men and women of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy) * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary artery disease will be at the discretion of the attending physician. * Uncontrolled active infection unless curable with treatment of their cancer.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
    intervention Names
    1. Drug: docetaxel
    2. Drug: cisplatin
    3. Drug: hydroxyurea
    4. Drug: fluorouracil
    5. Procedure: chemotherapy
    6. Procedure: radiotherapy
    label
    Induction plus chemoradiotherapy
    type
    ACTIVE_COMPARATOR
  2. description
    Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.
    intervention Names
    1. Drug: docetaxel
    2. Drug: hydroxyurea
    3. Drug: fluorouracil
    4. Procedure: chemotherapy
    5. Procedure: radiotherapy
    label
    Chemoradiotherapy
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Chemoradiotherapy
    2. Induction plus chemoradiotherapy
    description
    75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
    name
    docetaxel
    type
    DRUG
  2. arm Group Labels
    1. Induction plus chemoradiotherapy
    description
    75 mg/m2 on day 1
    name
    cisplatin
    type
    DRUG
  3. arm Group Labels
    1. Chemoradiotherapy
    2. Induction plus chemoradiotherapy
    description
    Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
    name
    hydroxyurea
    type
    DRUG
  4. arm Group Labels
    1. Chemoradiotherapy
    2. Induction plus chemoradiotherapy
    description
    750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
    name
    fluorouracil
    type
    DRUG
  5. arm Group Labels
    1. Chemoradiotherapy
    2. Induction plus chemoradiotherapy
    description
    See protocol for details
    name
    chemotherapy
    type
    PROCEDURE
  6. arm Group Labels
    1. Chemoradiotherapy
    2. Induction plus chemoradiotherapy
    description
    See protocol for details
    name
    radiotherapy
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
285
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Survival rates over 6 years.
    measure
    Overall Survival: Time From Randomization to Death From Any Cause
    time Frame
    Up to 6 years
secondary Outcomes
  1. description
    DFFS rates over 6 years. DFFS is time from randomization to distant recurrence or death from any cause
    measure
    Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause
    time Frame
    Up to 6 years
  2. description
    Recurrence-free survival rates over 6 years. Recurrence-free survival is time from randomization to local, regional, or distant recurrence or death from any cause
    measure
    Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause
    time Frame
    Up to 6 years
  3. description
    Percentage of patients with local/regional recurrence
    measure
    Failure Pattern (Local/Regional Recurrence)
    time Frame
    Up to 6 years
  4. description
    Percentage of patients with distant recurrence
    measure
    Failure Pattern (Distant Recurrence)
    time Frame
    Up to 6 years
  5. description
    FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)
    measure
    Quality of Life (FACT H&N)
    time Frame
    Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
  6. description
    Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
    measure
    Quality of Life (Normalcy of Diet)
    time Frame
    Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
  7. description
    Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
    measure
    Quality of Life (Speech)
    time Frame
    Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
  8. description
    McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)
    measure
    Quality of Life (McMaster)
    time Frame
    Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
  9. description
    FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)
    measure
    Quality of Life (FACT H&N)
    time Frame
    Change from baseline to 1 year (1 year-pre)
  10. description
    Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
    measure
    Quality of Life (Normalcy of Diet)
    time Frame
    Change from baseline to 1 year (1 year-pre)
  11. description
    Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
    measure
    Quality of Life (Speech)
    time Frame
    Change from baseline to 1 year (1 year-pre)
  12. description
    McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)
    measure
    Quality of Life (McMaster)
    time Frame
    Change from baseline to 1 year (1 year-pre)
Full study description
brief Summary
The combined use of chemotherapeutic drugs with radiation has proven to be effective in improving overall survival and local control among patients with locally advanced head and neck cancer. Induction chemotherapy given before receiving local treatment has been shown to reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from growing or dividing, although it has yet to be determined which agent, or specific combination of agents, is most effective in treating head and neck cancer. Docetaxel is a drug which has been reported to show promising activity in Phase II head and neck cancer studies. Therefore, the purpose of this trial is to compare the effectiveness of induction chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in patients with locally advanced head and neck cancer.
detailed Description
TRIAL DESIGN: Phase III trial of induction therapy with docetaxel followed by chemoradiotherapy versus chemoradiotherapy alone in patients with nodal stage N2 or N3 head and neck cancer OBJECTIVES: Primary * To determine the effect on overall survival when induction chemotherapy is administered prior to chemoradiotherapy in patients with N2 or N3 disease. Secondary * To determine the effect of induction chemotherapy when administered prior to chemoradiotherapy on distant failure-free survival, failure pattern, progression free survival and quality of life. TREATMENT PLAN: * After eligibility is confirmed, patients will be randomized to one of two treatment arms: Arm A - Induction + chemoradiotherapy Arm B - Chemoradiotherapy alone * Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (day 1), cisplatin (day 1), and 5-fluorouracil (days 1-5). Total duration of 6 weeks. * Chemoradiotherapy: Five 14-day cycles of docetaxel (day 1), 5-fluorouracil (day 0-4), and hydroxyurea (days 0-4) with twice daily radiation (days 1-5). Total duration of 10 weeks. * All patients will undergo surgical evaluation after chemoradiation for possible neck dissection. * Upon completion of treatment, patients will be monitored every three months during the first year, every six months during the second and third years, and annually thereafter, up to seven years. * Patients will be followed for Quality of Life (QOL) during the course of treatment, as well as annually thereafter, up to five years. PROJECTED ACCRUAL: * An expected sample size of 400 patients will be enrolled for this study (200 per treatment arm).
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice