Stage IV Squamous Cell Carcinoma of the Hypopharynx Clinical Trial
Official title:
Phase II Trial Of Induction Chemotherapy Followed By Attenuated Chemoradiotherapy For Locally Advanced Head And Neck Squamous Cell Carcinoma Associated With Human Papillomavirus (HPV)
This phase II trial studies how well paclitaxel and carboplatin before radiation therapy with paclitaxel works in treating human papillomavirus (HPV)-positive patients with stage III-IV oropharynx, hypopharynx, or larynx cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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 paclitaxel and carboplatin before radiation therapy with paclitaxel may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the progression-free survival at 2 years in patients with HPV-positive head
and neck squamous cell carcinoma (HNSCC) who receive induction chemotherapy followed by dose
de-intensified chemoradiotherapy.
SECONDARY OBJECTIVES:
I. To determine the overall survival and local-regional control for patients with
HPV-positive HNSCC who receive induction chemotherapy and dose de-intensified
chemoradiotherapy.
II. To determine the incidence of acute grade 3+ mucosal and esophageal toxicity associated
with attenuated concurrent chemoradiotherapy in patients with HPV-positive HNSCC.
III. To determine the incidence of late toxicity in patients with HPV-positive HNSCC who
receive the dose de-intensified chemoradiotherapy.
IV. To estimate the incidence of all toxicity (hematologic and non-hematologic) associated
with protocol treatment for all patients on trial.
V. To estimate the response rate of HPV-positive to induction chemotherapy using carboplatin
and paclitaxel.
VI. To determine the effect of reduced radiation dose on short-term and long-term quality of
life among patients treated by chemoradiotherapy.
OUTLINE:
INDUCTION: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV
over 30 minutes. Treatment repeats every 21 days for up to 2 courses in the absence of
disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY: At least 2 weeks after completion of induction chemotherapy, patients
receive paclitaxel IV over 1 hour weekly and undergo intensity-modulated radiation therapy
(IMRT) daily 5 days a week for 5.5 weeks in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up at 6, 9, and 12 months, every 3
months for 1 year, and then every 6 months for 2 years.
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