Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Musculoskeletal Diseases

Rare Diseases

Head and Neck Neoplasms

Laryngeal Diseases

Paranasal Sinus Neoplasms

Laryngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Nose Neoplasms

Nose Diseases

Paranasal Sinus Diseases

Laryngeal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Antisickling Agents

Docetaxel

Fluorouracil

Cisplatin

Hydroxyurea

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

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.

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.

75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)

docetaxel

cisplatin

Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)

hydroxyurea

750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)

fluorouracil

chemotherapy

radiotherapy

Everett Vokes, M.D.

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.

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).

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

A Phase III Randomized Trial of Docetaxel Based Induction Chemotherapy in Patients With N2/N3 Locally Advanced Head and Neck Cancer

DFFS rates over 6 years. DFFS is time from randomization to distant recurrence or death from any cause

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

Percentage of patients with local/regional recurrence

Percentage of patients with distant recurrence

FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)

Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)

McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)

University of Chicago

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.

docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)

cisplatin: 75 mg/m2 on day 1

hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)

fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)

chemotherapy: See protocol for details

radiotherapy: See protocol for details

Induction Plus Chemoradiotherapy

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.

docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)

hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)

fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)

chemotherapy: See protocol for details

radiotherapy: See protocol for details

Chemoradiotherapy

Total

Age, Continuous

Sex: Female, Male

France

United States

Spain

Croatia

Russia

Region of Enrollment

Dr. Ezra E.W. Cohen

Overall Survival: Time From Randomization to Death From Any Cause

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

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

Failure Pattern (Local/Regional Recurrence)

Failure Pattern (Distant Recurrence)

Survivors who completed the questionnaire. (Patients with missing data excluded.)

Quality of Life (FACT H&N)

Quality of Life (Normalcy of Diet)

Quality of Life (Speech)

Quality of Life (McMaster)

Overall Study

Behaviors and Mental Disorders

Quality of Life

Patients who have been diagnosed with Carcinoma of the oral cavity

Patient will fill out questionnaires, initial clinic visit, first post-surgery clinic evaluation and 3, 6, 12, 18 and 24 months following completion of all therapy.

questionnaires

Snehal Patel, MD

The purpose of this study is to learn more about the quality of life and emotional changes that patients experience during their treatment for cancer of the mouth. We want to learn more about the emotional and quality of life problems that occur during and after treatment. This will help us better understand these complex issues and improve treatment.

The objectives of this project are to prospectively assess quality of life (QOL) and psychosocial adaptation in patients undergoing treatment for carcinoma of the oral cavity, including squamous cell carcinoma of the oral cavity (SCCOC) and to validate new instruments (shame \& stigma, demoralization) that will guide quality of life assessment of patients with cancer of the oral cavity. We will utilize modifications of previously described and validated questionnaires that will be administered to eligible patients before the start of their therapy and at several predefined time points during the post-therapy period. This prospective longitudinal assessment will allow us to study the impact of patient demographic, tumor, treatment and lifestyle related variables on the quality of life of patients treated for oral cavity cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)	NCT00117572	Cancer of the P... Cancer of the L... Cancer of the N... Paranasal Sinus... Cancer of the O...	docetaxel cisplatin hydroxyurea fluorouracil chemotherapy radiotherapy	18 Years -	University of Chicago
Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)	NCT00117572	Cancer of the P... Cancer of the L... Cancer of the N... Paranasal Sinus... Cancer of the O...	docetaxel cisplatin hydroxyurea fluorouracil chemotherapy radiotherapy	18 Years -	University of Chicago
Quality of Life and Development of Measures in Patients With Cancer of the Oral Cavity	NCT00582413	Cancer of the O...	questionnaires	-	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for cancer of the oral cavity