Phase 3
Completed N=285
Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)
Cancer of the Pharynx · Cancer of the Larynx · Cancer of the Nasal Cavity · Paranasal Sinus Neoplasms
Source: ClinicalTrials.gov NCT00117572 ↗
Enrolled (actual)
285
Serious AEs
37.7%
Results posted
Apr 2018
Primary outcomePrimary: Overall Survival: Time From Randomization to Death From Any Cause — 74.9; 72.8 percentage of participants — p=0.68
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival: Time From Randomization to Death From Any Cause |
74.9; 72.8 | 0.68 |
| SECONDARY Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause |
69.3; 63.8 | 0.37 |
| SECONDARY Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause |
68.6; 58.6 | 0.16 |
| SECONDARY Failure Pattern (Local/Regional Recurrence) |
10.1; 12.6 | 0.57 |
| SECONDARY Failure Pattern (Distant Recurrence) |
13.8; 21.5 | 0.11 |
| SECONDARY Quality of Life (FACT H&N) |
-7.60; -7.34 | 0.88 |
| SECONDARY Quality of Life (Normalcy of Diet) |
-10.22; -8.89 | 0.83 |
| SECONDARY Quality of Life (Speech) |
-1.70; -3.41 | 0.49 |
| SECONDARY Quality of Life (McMaster) |
-3.29; -6.00 | 0.090 |
| SECONDARY Quality of Life (FACT H&N) |
-7.60; -7.34 | 0.88 |
| SECONDARY Quality of Life (Normalcy of Diet) |
-10.22; -8.89 | 0.83 |
| SECONDARY Quality of Life (Speech) |
-1.70; -3.41 | 0.49 |
| SECONDARY Quality of Life (McMaster) |
-3.29; -6.00 | 0.090 |
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.
Data sourced from ClinicalTrials.gov (NCT00117572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.