Clinical Research Directory

Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study

This clinical trial studies how well intensity modulated proton therapy (IMPT) or intensity modulated X-ray (radiation) therapy (IMRT) works after surgery in treating patients with head and neck cancer. IMPT is a type of radiation therapy that allows for the most accurate application of proton radiation to the tumor and has the potential to reduce treatment-related side effects. IMRT is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of x-ray radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. IMPT may work as well as IMRT after surgery in treating patients with head and neck cancer.

Impact of Preoperative High-Frequency Ultrasound Cutaneous Lesion Extent Assessment on Excision Margin Positivity in Head and Neck Skin Cancer, and the Relationship Between Preoperative Assessment Methods, Inadequate Excision Margins, and Tumor Recurrence

Non-melanoma skin cancers (NMSC), particularly basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC), are the most common malignancies in Caucasians, with the majority of tumors located in the head and neck due to chronic ultraviolet exposure. Although BCC has very low metastatic potential, while cSCC carries a higher risk of nodal spread, both can cause significant local tissue destruction and functional and cosmetic impairment. Complete excision with histologically clear margins remains the standard treatment; however, incomplete or close excision margins are reported in a substantial proportion of cases and are associated with increased risk of local recurrence, need for additional treatment, and higher healthcare costs. Preoperative dermoscopy improves delineation of lateral tumor borders but does not assess depth of invasion. High-frequency ultrasound (HFUS) is a rapid, non-invasive imaging modality that can visualize superficial skin structures and estimate tumor thickness. Previous studies have suggested good agreement between HFUS and histopathologic depth of invasion, but results are not fully consistent, and HFUS has not yet been incorporated into major guideline recommendations for preoperative assessment of NMSC. Further prospective data are needed to clarify whether HFUS can improve surgical planning and margin control. This prospective study is designed to assess the impact of adding preoperative HFUS to standard dermoscopic evaluation in head and neck BCC and cSCC. The primary objectives are: (1) to compare the frequency of positive or inadequate (\<1 mm) histopathologic excision margins between lesions assessed with dermoscopy alone and those assessed with both dermoscopy and HFUS; and (2) to evaluate 5-year local recurrence rates in relation to preoperative assessment method, histopathologic margin status, and subsequent management of inadequate margins (observation, non-surgical treatment, or scar excision). Secondary and additional objectives include: assessing concordance between HFUS-measured and histopathologic depth of invasion; determining the frequency of residual tumor in scars excised after inadequate margins; evaluating recurrence rate according to the site of inadequate margins (lateral vs deep); and identifying patient-related, tumor-related, surgical, and histopathologic predictors of inadequate margins and recurrence. Approximately 400 lesions (BCC or cSCC of the head and neck) qualified for curative surgical excision will be included. Each lesion will constitute an independent study case. All lesions will undergo preoperative assessment, including clinical evaluation with detailed medical history and dermoscopy; in one cohort, lesions will additionally be evaluated with HFUS. HFUS will be performed with an 18-MHz linear probe, using superficial B-mode and color Doppler. Maximum tumor depth will be recorded from the epidermal surface (or granular layer) to the deepest hypoechoic point, with assessment of potential infiltration of deeper structures when visible. Surgical excision and postoperative care will follow standard clinical practice. Postoperative histopathologic assessment of FFPE tumor samples will record tumor histologic type and subtype, margin status, width, depth of invasion, differentiation, inflammation, elastosis, perineural or vascular invasion, and other routinely assessed diagnostic features. In the event of positive or inadequate excision margins, patients will be referred, after consultation with a dermatologist, for further management (observation, non-surgical treatment, or scar excision), depending on clinical indications and patient preferences. Participation in the study will not influence the primary surgical treatment or any decisions regarding subsequent management. Patients will be followed for at least 5 years according to current clinical guidelines, with dermoscopic skin examination and documentation of local recurrence and its management. The study aims to determine whether incorporating HFUS into preoperative assessment can reduce the frequency of inadequate histologic margins and improve long-term local control in head and neck NMSC.

Magnetic Resonance (MR) Imaging & Blood Biomarkers for Head and Neck Cancer

The goal of this research study is to find out if using additional MRIs and biomarker testing can help researchers learn to predict how the tumor may change during radiation therapy. Biomarkers are found in the blood/tissue and may be related to participant's reaction to treatment. Biomarker testing in the study may include genetic biomarkers. This is an investigational study. MRIs on this study are performed using FDA-approved and commercially available methods. Having added scans and blood tests is investigational. Up to 100 participants will be enrolled in this study (up to 80 patients and up to 20 healthy volunteers in another part of the study). All will take part at MD Anderson.

Phase 2 Pragmatic Trial of Sentinel Lymph Node Biopsy (SLNB) in Patients With Clinically Node-Negative (cN0), High-Risk Cutaneous Squamous Cell Carcinoma (cSCC) of the Head and Neck

This is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of SLNB in patients with high-risk cSCC and cN0. The primary goal is to evaluate the efficacy of SLNB based on the DFS rate at 2 years post-definitive therapy.

Towards Cure Via Only Ultra-short ICB in CSCC

The goal of this clinical trial is to determine whether cutaneous squamous cell carcinoma patients can be cured using only immunotherapy, without surgery or radiotherapy.

Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radiation

This clinical trial tests the impact of offering hearing tests (audiometry) close to home and remotely on participation in monitoring for treatment-related hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and/or radiation. Cisplatin, a chemotherapy often used to treat head and neck cancers, and radiation given near the ear can cause hearing loss in some patients. Hearing loss can have a major negative impact on quality of life, contributing to social isolation and frustration. Identifying hearing changes may allow treatment changes to prevent further loss. Audiometry measures hearing loss using a graphic record of the softest sounds that a person can hear at various frequencies. It is recommended patients have a hearing test before, during and after treatment to monitor for any hearing loss. This is usually done in the office and performed on the same day as other visits whenever possible, however, patients who live far away or have stage IV cancer, may have more difficulty coming back for hearing tests. Offering close to home and remote audiometry may improve monitoring for hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and/or radiation.

Needs and Preferences of Patients With Head-neck Cutaneous SCC

The care of patients with high-risk cutaneous squamous cell carcinomas in the head-neck area is complex and requires a multidisciplinary approach. A key component in this care is the need and experience of patients. However, studies on the experiences and needs of patients with high-risk cutaneous squamous cell carcinomas in the head-neck region are lacking.

Deep sequencIng in Cutaneous Squamous CEll caRciNomas

To comprehensively describe the molecular profile of the tumour ecosystem of cutaneous squamous cell carcinoma (CSCC) patients treated with neoadjuvant immunotherapy using single-cell sequencing and bulk genomic profiling.

Neoadjuvant Pembrolizumab in Cutaneous Squamous Cell Carcinoma

Cutaneous Squamous Cell Carcinoma (cSCC) is typically associated with a high tumour mutation burden, with the majority caused by Ultraviolet (UV) exposure (Pickering et al., 2014). The use of this trial using neoadjuvant Pembrolizumab in patients with cSCC who will otherwise undergo highly morbid radical surgical resection has multiple potential advantages, including: 1. Reduction in surgical and radiotherapy morbidity by reducing tumour burden and allowing the appropriate selection of patients to undergo post-operative radiotherapy; 2. Provision of immediate information about pathological response and 3. Access to tissue to provide insight into resistance mechanisms and identification of biomarkers of response. The Investigators hypothesized that the use of neoadjuvant Pembrolizumab could reduce tumour burden allowing appropriate selection of patients undergoing radical surgical resection and adjuvant radiotherapy.