Carcinoma, Squamous Cell Clinical Trial
— HBO-XRTOfficial title:
Phase I Clinical Trial of Hyperbaric Oxygen Combined With Radiation and Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
This research is being done because we do not know the best treatment for advanced Squamous
Cell Carcinoma of the Head and Neck. These cancers have been treated with a combination of
surgery, radiation and chemotherapy in varying combination. When the tumor is inoperable,
radiation therapy is used with or without chemotherapy in the hope of curing the tumor.
Recently, it has become recognized as generalized knowledge that cancer cells are hypoxic
(low oxygen concentration). Because of the low oxygen concentrations, many cancer treatments
have not been successful. The theory behind this study is to give oxygen to patients prior
to chemotherapy and radiation in hopes of generating greater results in killing cancer
cells. The purpose of this study has two main objectives. The primary objective is to
determine patient tolerance to each arm of the trial.
The second objective is to determine the feasibility of treatment delivery and acute
toxicities associated with each regimen.
It is our intention to undertake a randomized and controlled trial should this Phase I trial
prove successful in terms of patient tolerance.
Status | Completed |
Enrollment | 12 |
Est. completion date | February 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patients with histological proof (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx. - Patients should have Stage III or IV disease, M0 - Patients must have life expectancy of at least 6 months and a Karnofsky performance status of = 70 - Age = 18 years and = 70 years - No distant metastatic disease - No clinically significant heart disease: - No significant ventricular arrhythmia requiring medication with antiarrhythmics - No symptomatic coronary artery disease (angina) - No myocardial infarction within the last 6 months - No second or third degree heart block or bundle branch block or clinically significant conduction system abnormality - Patients must sign a study-specific informed consent form Exclusion Criteria: - Histology other than squamous cell carcinoma - Evidence of metastasis (below the clavicle or distant) by clinical or radiographic means - Prior complete resection of the primary tumor - Prior chemotherapy (Bleomycin) for head and neck cancer or radiotherapy to the head and neck - Patients with simultaneous primaries - Pregnancy - Pulmonary pathologies (risk of decompression-induced pulmonary barotrauma): - Current, untreated pneumothorax - Previous history of pneumothorax - Previous history of intrathoracic surgery - History of pulmonary blebs or bullous lung disease - Associated with CO2 retention - Poorly controlled or associated with acute bronchospasm - Where the hyperbaric physician deems the patient to have an unacceptable risk for hyperbaric treatments - Claustrophobia |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Norfolk General Hospital / Eastern Virginia Medical School | Norfolk | Virginia |
United States | The Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Baromedical Research Foundation | Dartmouth-Hitchcock Medical Center, Eastern Virginia Medical School, Mayo Clinic, Palmetto Health Richland |
United States,
R.E. Clarke, T.H. Davis, R.L. Foote, et al. Hyperbaric oxygen as a radiation sensitizer for locally advanced squamous cell carcinoma of the head and neck: A phase I dose-escalation study. J Clin Oncol 28, 2010 (suppl; abstr e16002)
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient tolerance to each arm of the study | During intervention phase | No | |
Secondary | Grade IV acute toxicities associated with each arm of the study | During intervention phase | No |
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