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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02743832 -
A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.
|
N/A | |
Active, not recruiting |
NCT02229656 -
Olaparib and Radiotherapy in Head and Neck Cancer
|
Phase 1 | |
Completed |
NCT00389727 -
Simultaneous Integrated Boost (SIB)- IMRT
|
Phase 2 | |
Recruiting |
NCT02328391 -
STUDY OBSERVATIONAL OF ERLOTINIB AS SECOND LINE TREATMENT IN PATIENTS WITH SQUAMOUS NSCLC AND EGFR NATIVE
|
N/A | |
Completed |
NCT00534950 -
Randomized Multicenter Study of 5 vs 6 Weekly Fraction of RT in the Treatment of SCC of the Head and Neck
|
N/A | |
Completed |
NCT00875381 -
Analysis of Melanocytes (Pigment Cells) in Sun-Exposed Skin
|
N/A | |
Terminated |
NCT00073450 -
Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)
|
Phase 2 | |
Terminated |
NCT01441128 -
-02341066 and PF-00299804 for Advanced Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT05970497 -
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Completed |
NCT01362127 -
Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia
|
Phase 2 | |
Completed |
NCT00240682 -
Study of Cetuximab in Squamous Cell Carcinoma of the Skin Expressing EGFR
|
Phase 2 | |
Terminated |
NCT02254044 -
Dose Escalation of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus
|
Phase 1 | |
Active, not recruiting |
NCT00829192 -
Phase II AK Study in Organ Transplant Patients
|
Phase 2 | |
Completed |
NCT00313027 -
Cervical Nodal Mets in Squamous Cell Carcinoma of H&N - MRI, FDG-PET, & Histopathologic Correlation
|
N/A | |
Completed |
NCT00539630 -
TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN
|
Phase 3 | |
Recruiting |
NCT04564989 -
Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
|
||
Not yet recruiting |
NCT06094829 -
Tobacco and Alcohol Influence on Oncogenic Drivers and Somatic Evolution in the Oral Mucosa
|
||
Recruiting |
NCT04481256 -
TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY
|
N/A | |
Active, not recruiting |
NCT02664935 -
National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer
|
Phase 2 | |
Terminated |
NCT02438995 -
Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck
|
Phase 1 |