Oropharyngeal Squamous Cell Carcinoma Clinical Trial
Official title:
DART-HPV: A Phase III Evaluation of De-Escalated Adjuvant Radiation Therapy for HPV-Associated Oropharynx Cancer
This phase III trial studies docetaxel and radiation therapy and how well it works compared to standard of care therapy. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. It is not known if giving docetaxel with radiation therapy may kill more tumor cells than standard therapy.
PRIMARY OBJECTIVES:
I. To compare the rates and severity of late grade 3-5 toxicities and percutaneous endoscopic
gastrostomy (PEG) tube dependence between de-escalated adjuvant radiation therapy (DART) and
standard adjuvant therapy.
SECONDARY OBJECTIVES:
I. To assess the cumulative incidence of local/regional failure at 2 years after study
registration for patients treated with DART versus (vs) standard therapy.
II. To compare overall survival, disease-free survival, and distant failure associated with
DART vs standard treatment.
III. To compare the overall quality of life (QOL) between DART and standard adjuvant therapy
at 1-year post-treatment as measured by Functional Assessment of Cancer Therapy (FACT) Head
and Neck (H&N) and European Organization for Research and Treatment of Cancer (EORTC) H&N
quality of life questionnaire (QLQ) 35.
TERTIARY OBJECTIVES:
I. To determine the genetic alterations of oropharynx tumor specimens and the detection rate
of corresponding circulating deoxyribonucleic acid (DNA) in the pre-surgical, post-surgical,
and post-radiation blood of oropharynx cancer patients.
II. To investigate the usefulness of immunologic biomarkers in predicting progression free
survival.
III. To establish a patient derived xenograft panel from representative oropharynx patients.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (DART): Patients undergo 20 fractions of intensity-modulated radiation therapy (IMRT)
or image-guided radiation therapy (IGRT) twice daily (BID) on days 1-12 (Monday - Friday),
and receive docetaxel intravenously (IV) over 1 hour on days 1 and 8 in the absence of
disease progression or unacceptable toxicity.
ARM II (STANDARD OF CARE): Patients undergo 30 fractions of IMRT or IGRT daily on days 1-40
(Monday - Friday), and receive cisplatin IV weekly around days 1, 8, 15, 22, 29 and 36 in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 days post-radiation
therapy, at 1 month, every 3 months for 2 years, every 6 months for 1 year, then annually for
2 years.
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