Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 345
Summary
- Conditions
- p16INK4a Negative Oropharyngeal Squamous Cell Carcinoma
- Head and Neck Squamous Cell Carcinoma
- Stage IVA Oral Cavity Verrucous Carcinoma
- Hypopharyngeal Squamous Cell Carcinoma
- Laryngeal Squamous Cell Carcinoma
- Laryngeal Squamous Cell Carcinoma, Spindle Cell Variant
- Stage IVA Lip and Oral Cavity Cancer AJCC v8
- Lip and Oral Cavity Squamous Cell Carcinoma
- Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage III Hypopharyngeal Carcinoma AJCC v8
- Stage III Laryngeal Cancer AJCC v8
- Stage III Lip and Oral Cavity Cancer AJCC v8
- Stage IVA Laryngeal Cancer AJCC v8
- Stage III Oral Cavity Verrucous Carcinoma
- Stage IVA Hypopharyngeal Carcinoma AJCC v8
- Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To evaluate the disease-free survival (DFS) of patients with stage III-IV squamous cell carcinoma of the head and neck (SCCHN) and disruptive p53 mutations after primary surgical resection followed by postoperative radiotherapy (PORT) alone or PORT with concurrent cisplatin. S...
PRIMARY OBJECTIVES: I. To evaluate the disease-free survival (DFS) of patients with stage III-IV squamous cell carcinoma of the head and neck (SCCHN) and disruptive p53 mutations after primary surgical resection followed by postoperative radiotherapy (PORT) alone or PORT with concurrent cisplatin. SECONDARY OBJECTIVES: I. To evaluate the DFS of patients with stage III-IV SCCHN and non-disruptive p53 mutations after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin. II. To evaluate the DFS of patients with stage III-IV SCCHN and p53 wild type after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin. III. To evaluate toxicities of PORT alone or PORT with concurrent cisplatin. IV. To evaluate p53 mutation as a predictive biomarker of survival benefit given post-operative concurrent radiation and cisplatin. V. To identify potential genomic alterations in addition to TP53 mutations that may be developed to a novel treatment approach. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients undergo intensity-modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. ARM B: Patients undergo IMRT QD 5 days a week and receive cisplatin intravenously (IV) over 1-2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 3 years and then every 12 months for 7 years.
Tracking Information
- NCT #
- NCT02734537
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Robert Ferris ECOG-ACRIN Cancer Research Group