Vanguard Study for Head and Neck Cancer or Non-Small Cell Lung Cancer (NSCLC) Patients

Completed

Conditions studied: Head and Neck Cancer, Lung Cancer

In brief

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.

Key facts

Study ID

NCT00352391

Run by

M.D. Anderson Cancer Center

People needed

54

Starts

2004-08-01

Expected to finish

2016-01-01

Last updated by the study team

2016-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 %.
• Participants must complete the pretreatment evaluation and must consent to bronchoscopy and to endobronchial biopsy for biomarker studies.
• All subjects who agree to participate will be given a written and verbal explanation of the study requirements and a consent form that must be signed prior to registration. Subjects will be informed that (a) they must be willing to take biopsies through bronchoscopy and give blood samples at the specified times, (b) they must schedule and keep the specified follow-up visits with their physicians and the study clinics, and (c) side effects and health risks may occur, as described in the informed consent form.
• Smoking history of at least 10 pack years. May be current or former smoker.
• Subject must be considered legally capable of providing his or her own consent for participation in this study.
• HNSCC patients only: Must have no contraindications for undergoing laryngoscopy.

You may not qualify if…

• 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.
• Patients may not take high dose synthetic or natural Vitamin A derivatives (> 10,000 IU per day). "High dose" is defined as anything greater than a once-daily multivitamin. Any additional supplementation will be evaluated at the discretion of the treating physician.
• History of biologic therapy.

Where it is running

• Eisenhower Army Medical Center — Fort Gordon, Georgia, United States
• Conemaugh Memorial Medical Center — Johnstown, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.