Clinical trial NCT00352118
Conditions: Head and Neck Cancer
Keywords: oral complications of radiation therapy oral complications of chemotherapy mucositis xerostomia stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2006-03-01; Completion date: 2008-04-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Arms: arm 1: Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.
Interventions: intervention 1: filgrastim intervention 2: pegfilgrastim intervention 3: cisplatin intervention 4: docetaxel intervention 5: fluorouracil intervention 6: conventional surgery intervention 7: radiation therapy
Intervention descriptions: intervention 1: subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses. intervention 2: If applicable on day 5, repeating every 3 weeks for 2 courses. intervention 3: Intravenous over 1 hour on day 1, every 3 weeks for 3 courses. intervention 4: Intravenous over 1 hour on day 1. intervention 5: Intravenous continuously on days 1-4. intervention 6: As appropriate, neck dissection. intervention 7: 60 Gy 5 days/week x 6 weeks with cisplatin

Protocol documents: