Vanguard Study for Head and Neck Cancer or Non-Small Cell Lung Cancer (NSCLC) Patients (NCT00352391) | Clinical Trial Compass
CompletedNot Applicable
Vanguard Study for Head and Neck Cancer or Non-Small Cell Lung Cancer (NSCLC) Patients
United States54 participantsStarted 2004-08
Plain-language summary
The goal of this research study is to look at how long individuals who have been treated for early stage NSCLC or HNSCC live without developing lung cancer. Another goal is to develop tools to help predict the likelihood of lung cancer occurrence in this population. This will be done by studying characteristics of tissue and bodily fluids (including blood).
Objectives:
* To assess the smoking-related disease-free survival in patients who are current or former smokers with a prior definitively-treated stage I/II lung or head and neck cancer.
* To develop a risk model to help predict the likelihood of lung cancer development both imaging and biomarker based in this high-risk population.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients with either: a) histologically proven stage I, II, IIIa NSCLC who have undergone a complete surgical resection of the primary tumor OR b) stage I or II HNSCC who have undergone definitive local treatment (surgery or radiation therapy).
✓. HNSCC patients:Definitive local treatment \</= 12 months prior to trial enrollment. NSCLC patients: Surgery \</= 12 months prior to trial enrollment.
✓. No evidence residual cancer
✓. Age \> = 18 years
✓. Performance status of 0- 2 (Zubrod)
✓. Patients must have no contraindications for undergoing bronchoscopy.
✓. Patients must have no active pulmonary infections.
✓. Participants must have the following blood levels: total granulocyte count \>1500; platelet count \> 100,000; total bilirubin \< = 1.5 mg. %; and creatinine \< = 1.5 mg %.
Exclusion criteria
✕. History of radiation therapy to the chest. For those patients with head and neck cancer who received radiation, no more than 10% of the lung volume (apices) may be included.
✕. History of systemic chemotherapy. Exception: NSCLC patients may have had up to 4 cycles of platinum-based doublet therapy.
✕. Pregnant or breast-feeding (a negative pregnancy test within 72 hours of enrollment for women with child-bearing potential is required).
✕. Participants with active pulmonary infections or recent history of pulmonary infection (within one month).
✕. Participants with acute intercurrent illness.
✕. Participants requiring chronic ongoing treatment with NSAIDs except aspirin.
✕. Participants with history of stroke, uncontrolled hypertension, and/or uncontrolled angina pectoris.
✕. Patients may not take high dose antioxidants (vitamins E or C) during the study period. "High dose" will be determined by the study investigators.