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Cisplatin

Patients undergo IMRT QD 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo IMRT QD 5 days a week and receive cisplatin IV over 1-2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

Intensity-Modulated Radiation Therapy

Laboratory Biomarker Analysis

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Alison K. Conlin

Richard L. Deming

Jared R. Robbins

Jay W. Carlson

Amir Lavaf

Barbara A. Burtness

Susanna Hong

Chukwuemeka (Emeka) V. Ikpeazu

Christopher M. Reynolds

Caitlin McMullen

John M. Schallenkamp

Sinisa Stanic

Bryan A. Faller

Robert Ferris

This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, 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. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.

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.

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

Phase II Randomized Trial of Radiotherapy With or Without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) With TP53 Sequencing

Kaplan-Meier estimates will be used to estimate event-time distributions and comparison between arms will be performed using a log-rank test.

Toxicity will be examined by arm and compared using the Fisher's exact test.

To evaluate whether p53 is a predictive marker, a p53 by treatment arm interaction term will be tested in a Cox proportional hazards model.

National Cancer Institute (NCI)

ECOG-ACRIN Cancer Research Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT02734537	Head and Neck S... Hypopharyngeal ... Laryngeal Squam... Laryngeal Squam... Lip and Oral Ca... p16INK4a Negati... Stage III Hypop... Stage III Laryn... Stage III Lip a... Stage III Oral ... Stage III Oroph... Stage IVA Hypop... Stage IVA Laryn... Stage IVA Lip a... Stage IVA Oral ... Stage IVA Oroph...	Cisplatin Intensity-Modul... Laboratory Biom...	18 Years -	Eastern Cooperative Oncology Group
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	NCT02734537	Head and Neck S... Hypopharyngeal ... Laryngeal Squam... Laryngeal Squam... Lip and Oral Ca... p16INK4a Negati... Stage III Hypop... Stage III Laryn... Stage III Lip a... Stage III Oral ... Stage III Oroph... Stage IVA Hypop... Stage IVA Laryn... Stage IVA Lip a... Stage IVA Oral ... Stage IVA Oroph...	Cisplatin Intensity-Modul... Laboratory Biom...	18 Years -	Eastern Cooperative Oncology Group

Spots Global Cancer Trial Database for laryngeal squamous cell carcinoma, spindle cell variant