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Squamous Cell Carcinoma of Head and Neck

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Carcinoma, Verrucous

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Neoplasms, Squamous Cell

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Laryngeal Diseases

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Respiratory Tract Neoplasms

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Oral Squamous Cell Carcinoma

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Laryngeal Cancer

Hypopharyngeal Cancer

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Antineoplastic Agents

All Drugs and Chemicals

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

Site Public Contact

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

Symptoms and General Pathology

Recurrence

Disease Attributes

Tongue Cancer

Herbal and Botanical

Soy Bean

Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.

Soy Isoflavones

Survey Administration

Greg Wolf

This phase II clinical trial studies how well soy isoflavones work in preventing head and neck cancer in patients with stage I-IV head and neck cancer undergoing surgery. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy isoflavones may prevent head and neck cancer recurrence.

PRIMARY OBJECTIVES:

I. To determine if short term, preoperative (300 mg/day x 14 treatment days) soy isoflavone supplementation modulates p16 methylation (% CpG sites methylated) and expression of p16, cyclooxygenase 2 \[COX-2\], vascular endothelial growth factor receptor \[VEGF\], epidermal growth factor receptor \[EGFR\], interleukin-6 \[IL6\], p53 and B-cell lymphoma-extra large \[Bcl-xL\] in tumor and non-tumor adjacent mucosa of patients with head and neck squamous carcinoma undergoing curative tumor resection.

II. To estimate correlations of tumor p16 methylation (% CpG sites methylated) with expression of p16 and levels of, IL6, VEGF, and 15-F2t-isoprostane in serum and saliva.

SECONDARY OBJECTIVES:

I. Describe the toxicity of short-term, preoperative treatment with soy isoflavone.

II. To determine overall and relapse-free survival.

OUTLINE:

Patients receive soy isoflavones orally (PO) for approximately 14 days before undergoing surgery.

After completion of treatment, patients are followed up, within the routine cancer management schedule, at 3, 6, 12, and 24 months.

Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery

A Phase II Trial of Preoperative Soy Isoflavone Supplementation and Molecular Markers in the Prevention of Head and Neck Squamous Carcinoma

The change in methylation will be analyzed in parallel using a linear repeated measures model. The fixed effects will be time (pre-treatment versus post-treatment), current smoking status (yes or no), their interaction, and tissue type (tumor or not). Satterthwaite's adjustment to the degrees of freedom will be applied to account for heteroscedasticity. The differential effect of soy isoflavone on tumor and non-tumor tissues between smokers and non-smokers will be assessed using linear contrasts.

Each of the tumor and mucosal markers will be dependent variables in repeated measures models that include serum and saliva markers as predictors. Graphical analyses will be used to characterize possible nonlinear relationships between variables. Linear or nonlinear regression, as appropriate, will be used to characterize the relationship between the putative predictors and outcomes. Subset analyses, considering, for example, differences in relationships between tumor markers and serum and saliva markers between smokers and non-smokers will be performed by means of indicator variables.

Overall survival at last follow-up will be determined.

Relapse-free survival will be determined at the last follow-up visit.

55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.

Treatment (Soy Isoflavones)

Age, Continuous

Sex: Female, Male

55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.

Gregory T. Wolf, M.D.

Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone

We are seeking additional funding to hire the personnel to perform the serum/saliva markers. Until further notice markers will be unable to be analyzed.

Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF

The Number of Participants Alive at Follow-up

The Number of Participants Alive Without Relapse at Last Follow-up

Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.

55 patients were enrolled. 3 of these patients did not receive treatment.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery	NCT02007200	Recurrent Hypop... Recurrent Laryn... Recurrent Laryn... Recurrent Lip a... Recurrent Oral ... Recurrent Oroph... Stage I Hypopha... Stage I Larynge... Stage I Larynge... Stage I Lip and... Stage I Oral Ca... Stage I Orophar... Stage II Hypoph... Stage II Laryng... Stage II Laryng... Stage II Lip an... Stage II Oral C... Stage II Oropha... Stage III Hypop... Stage III Laryn... Stage III Laryn... Stage III Lip a... Stage III Oral ... Stage III Oroph... Stage IV Hypoph... Stage IVA Laryn... Stage IVA Laryn... Stage IVA Lip a... Stage IVA Oral ... Stage IVA Oroph... Tongue Carcinom...	Laboratory Biom... Soy Isoflavones Survey Administ...	19 Years - 79 Years	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for stage iii oral cavity verrucous carcinoma