Clinical Trials

A clinical study involves research using voluntarily participants, observing and collecting data for medical knowledge. Clinical studies are led by a principal investigator, often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals. There are two main types research that we offer: clinical trials and observational studies. 

  • In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators
  • In an observational study, investigators assess outcomes in groups of participants according to a research plan or protocol

Airway, Voice, and Swallowing

A Randomized Study of Mitomycin-C Application in the Endoscopic Surgical Treatment of Patients With Laryngotracheal Stenosis

Obstruction of the upper airway caused by laryngotracheal stenosis (LTS) often results in severe morbidity and even mortality. Treatment of LTS continues to present a challenge and a wide array of surgical techniques have been employed. Despite multiple endoscopic and/or open reconstructive procedures, patients often experience restenosis as a result of the abnormal wound-healing process that initially instigated the airway obstruction. The high rate of stenosis relapse has therefore motivated researchers to find new methods to modulate and control the wound-healing process of the airway. Although other adjuvant treatments such as steroids and antibiotics have been investigated in LTS, much attention in recent years has turned to the use of topical mitomycin-C (MMC). As a topical application, MMC has been shown to inhibit fibroblast proliferation in wound-healing processes. The use of MMC in the treatment of airway stenosis was first reported in 1998 and is now routinely used in the endoscopic management of LTS. However, despite numerous animal and human studies, the benefit of MMC in LTS patients remains questionable. While previously published retrospective data suggest that the addition of MMC improves outcome, there have been no prospective studies to directly address the efficacy of MMC in endoscopic LTS surgery. This study will be the first randomized, prospective, double-blind, placebo controlled clinical trial designed to investigate the efficacy of MMC as an adjunctive therapy to endoscopic surgical treatment in patients with LTS. In addition, the study will investigate the relationship between patient symptoms and objective pulmonary function measurements. Ultimately, the results of this study may influence the treatment and evaluation of patients with laryngotracheal stenosis.

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Study Number

NCT01523275

Key individuals

Principal Investigator
Katherine C. Yung, MD

Contact Information

Katherine C. Yung, MD
Phone: (415) 353-7323
Email: katherine.yung@ucsf.edu

Theresa Apice, RN
Phone: (415) 353-2870
Email: Theresa.Apice@ucsfmedctr.org

Head and Neck Oncology

A Randomized Phase II Study of Concurrent Intensity Modulated Radiation Therapy (IMRT), Paclitaxel and Pazopanib (NSC 737754)/Placebo, for The Treatment of Anaplastic Thyroid Cancer

This randomized phase II trial is studying the side effects and how well giving intensity-modulated radiation therapy (IMRT) and paclitaxel together with or without pazopanib hydrochloride works in treating patients with anaplastic thyroid cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving radiation therapy and paclitaxel together is more effective with pazopanib hydrochloride in treating thyroid cancer.

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Study Number

RTOG 0912

Key individuals

Principal Investigator: Jeanne Quivey, MD
Principal Investigator: Sue Yom, MD

Contact

Mallory Kock
Phone: (415) 502-3398
Email: mallory.kock@ucsf.edu

A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer

This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with cetuximab in treating patients who have undergone surgery for locally advanced head and neck cancer.

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Study Number

RTOG 0920

Key individuals

Principal Investigator: Jeanne Quivey, MD
Principal Investigator: Sue Yom, MD

Contact

Mallory Kock
Phone: (415) 502-3398
Email: mallory.kock@ucsf.edu

A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors

This randomized phase II trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.

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Study Number

RTOG 1008

Key individuals

Principal Investigator: Jeanne Quivey, MD
Principal Investigator: Sue Yom, MD

Contact

Mallory Kock
Phone: (415) 502-3398
Email: mallory.kock@ucsf.edu

Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin versus Docetaxel versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck

This randomized phase II/III trial studies how well radiation therapy works when given together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in treating patients with stage III-IV squamous cell head and neck cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or transmit tumor killing molecules to them. It is not yet known whether radiation therapy is more effective when given with cisplatin, docetaxel, or cetuximab and docetaxel.

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Study Number

RTOG 1216

Key individuals

Principal Investigator: Sue Yom, MD

Contact

Mallory Kock
Phone: (415) 502-3398
Email: mallory.kock@ucsf.edu

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Lapatinib for Non-HPV Locally Advanced Head and Neck Cancer with Concurrent Chemoradiation

This trial is studying if and how well lapatinib adds to the effectiveness of radiation therapy plus cisplatin in patients who have head and neck cancer that is not related to the HPV virus.

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Study Number

RTOG 3501

Key individuals

Principal Investigator: Sue Yom, MD

Contact

Mallory Kock
Phone: (415) 502-3398
Email: mallory.kock@ucsf.edu

Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)

There are two study questions the investigators are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and flurouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel 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 whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.

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Study Number

NRG HN001

Key individuals

Principal Investigator: Sue Yom, MD

Contact

Mallory Kock
Phone: (415) 502-3398
Email: mallory.kock@ucsf.edu

A Phase II Study of Radiation Therapy and Vismodegib, for the Treatment of Locally Advanced Basal Cell Carcinoma of the Head and Neck

This is a single arm, multi-centered Phase II clinical trial to assess the safety and demonstrate the efficacy of a combined modality approach using radiation therapy after induction and concurrently with systemic administration of vismodegib, which may increase the rates of complete response and sustained local control in patients with locally advanced BCC

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Study Number

VISMO-122011

Key individuals

Principal Investigator: Sue Yom, MD

Contact

Mallory Kock
Phone: (415) 502-3398
Email: mallory.kock@ucsf.edu

A Phase III Randomized Trial of MK-3475 (Pembrolizumab) versus Standard Treatment in Subjects with Recurrent or Metastatic Head and Neck Cancer

This is a study of pembrolizumabversus standard treatment (methotrexate, docetaxel, or cetuximab) for the treatment of recurrent or metastatic head and neck squamous cell cancer (HNSCC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment. The primary study hypothesis is that pembrolizumab treatment prolongs progression-free survival and overall survival when compared to standard treatment.

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Study Number

NCT02252042

Key individual

Principal Investigator: Alain Algazi, MD

Contact

Mallory Kock
Phone: (415) 502-3398
Email: mallory.kock@ucsf.edu

A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer Patients

The purpose of this study is to evaluate the activity and safety of KTN3379 in head and neck cancer patients and to explore downstream molecular pathways to identify tumor response and resistance mechanisms by evaluating various biomarkers before and after treatment.

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Study Number

NCT02473731

Key individual

Principal Investigator: Jonathan George, MD, MPH

Contact

Mallory Kock
Phone: (415) 502-3398
Email: mallory.kock@ucsf.edu

A Phase 2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subject with Advanced Head and Neck Squamous Cell Carcinoma

Study of the combination of ACP-196 and pembrolizumab in subjects with advanced head and neck squamous cell carcinoma.

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Study Number

NCT02454179

Key individual

Principal Investigator: Alain Algazi, MD

Contact

Mallory Kock
Phone: (415) 502-3398
Email: mallory.kock@ucsf.edu

A Randomized Phase II Trial For Patients With p16 Positive, Non-Smoking Associated, Locoregionally Advanced Oropharyngeal Cancer

This randomized phase II trial studies how well modestly reduced-dose intensity-modulated radiation therapy (IMRT) with or without cisplatin works in treating patients with oropharyngeal cancer that has spread to other places in the body (advanced). Radiation therapy uses high energy x rays to kill tumor cells. 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 whether IMRT is more effective with or without cisplatin in treating patients with oropharyngeal cancer.

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Study Number

NCT02254278

Key individual

Principal Investigator: Sue Yom, MD

Contact

Mallory Kock
Phone: (415) 502-3398
Email: mallory.kock@ucsf.edu

A randomized, phase II study of definitive radiotherapy with concurrent cisplatin vs. docetaxel-cetuximab in locally advanced head and neck squamous cell carcinoma: an ERCC1 biomarker enrichment and interaction design

The goal of this clinical research study is to learn which chemotherapy combination may be more effective in treating locally advanced head and neck squamous cell carcinoma (HNSCC). The side effects of these combinations will also be studied.

This study treatment consists of intensity-modulated radiation therapy (IMRT) and concurrent chemotherapy. For study chemotherapy, patients will be randomized between cisplatin or the combination of docetaxel and cetuximab. Subjects will be stratified depending on HPV status and the presence of ERCC-1 [4F9] in the tumor prior to randomization. The study will evaluate cisplatin vs. docetaxel-cetuximab in the overall population, and test which radiation and chemotherapy combination works best in relationship to how much ERCC-1 [4F9] is expressed in a tumor.

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Study Number

NCT02128906

Key individual

Principal Investigator: Sue Yom, MD

Contact

Mallory Kock
Phone: (415) 502-3398
Email: mallory.kock@ucsf.edu

Pediatric Otolaryngology

Comparison of pure-tone audiometric and otoacoustic emission testing for hearing loss in pre-school-aged children

Early identification and intervention for hearing loss in children is critical to prevent future speech, language, educational, and cognitive impairment. Though universal newborn hearing screening has been highly successful at identifying deaf and hard of hearing babies at birth, there is no subsequent mechanism for hearing screening until the start of school. Currently, preschool hearing screening is highly variable, and outcomes are uncertain. We have partnered with the San Francisco Department of Public Health to optimize screening and follow-up strategies in preschoolers. In an accompanying study, we are recruiting children aged 3-10 with hearing loss or normal hearing, to test different ways of screening for hearing loss. Participants will be compensated for their time. This study will help us better identify hearing loss in preschoolers so they can receive appropriate intervention and be ready for school entry.

Eligiibility: children aged 3-10 years of age with permanent hearing loss, or with normal hearing.

Study Number

15-16293

Contact

Cimeran Kapur
Phone: (415) 530-0830
Email: cimeran.kapur@ucsf.edu

 

Impact of unilateral hearing loss and mild to moderate bilateral hearing loss on language proficiency in bilingual children

Hearing loss is a major cause of speech, language, and educational delay. Hearing loss is more prevalent in non-white ethnic groups, and children whose home language is not English have increased risk for language and educational challenges. In this study, we are examining speech, language, educational, and behavioral outcomes in children who are deaf or hard of hearing and whose home language is not English. By identifying the specific challenges that this group has, we hope to develop targeted interventions to improve outcomes.

Eligiibility: children aged 6-17 years of age with mild-to-moderate OR single-sided permanent hearing loss, whose home language is not English.

Study Number

15-17261

Contact

Cimeran Kapur
Phone: (415) 530-0830
Email: cimeran.kapur@ucsf.edu

Development of an Infant/Toddler Hearing-Related Quality of Life Survey Instrument

A new diagnosis of hearing loss is challenging for parents. Learning how to manage many different options for intervention, the medical and community service systems, and a new infant or toddler who may have communication difficulties is taxing to a family's quality of life. In this study, we are interviewing medical, service, and educational providers for deaf and hard-of-hearing infants and toddlers, as well as the parents themselves, to learn how their child's hearing affects the quality of life of the child him/herself, as well as the family unit. From this, we aim to design and validate a survey instrument to measure quality of life in this population. This instrument will help us and others measure how different multidisciplinary interventions help a family and child manage hearing loss.

Eligibility: Deaf and hard-of-hearing children aged 6 months-3 years, with English-speaking parents.

Study Number

15-16760

Contact

Cimeran Kapur
Phone: (415) 530-0830
Email: cimeran.kapur@ucsf.edu