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

NCT00352391 | Completed DMC

• 1 other identifier: 2003-0424
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Head and Neck Cancer; Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Head And Neck Cancer; Lung Cancer; Bronchoscopy; Laryngoscopy; NSCLC; Disease Free Survival; Current Smoker; Former Smoker

Outcome Measures

Primary Outcomes (1)

• Smoking-Related Disease-Free Survival (S-DFS)

  Smoking-related disease-free survival (S-DFS) defined as time from registration to the development of recurrence, smoking related SPT, or disease-specific death, whichever occurs first.

  6 Years

Study Arms (1)

Vanguard Study

Patients with Head and Neck or Non-Small Cell Lung Cancer who are Current or Former Smokers.

Other: Assessments

Interventions

Assessments OTHER

At Months 6, 12, 18, 24, 30, and 36, complete medical history will be recorded, and a physical exam will be performed by either a doctor or a nurse. At each of these visits, blood will be drawn for routine tests (about 3 teaspoons) and for research purposes (about 4 teaspoons). Also, a chest x-ray and a chest CT will be done at these visits.

Vanguard Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a prior history of a definitively treated stage I/II head and neck or non-small cell lung cancer who are current or former smokers.

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• United States Department of Defense: collaborator

Study Sites (3)

Eisenhower Army Medical Center

Fort Gordon, Georgia, 30905, United States

Location

Conemaugh Memorial Medical Center

Johnstown, Pennsylvania, 15901, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

Biospecimen

Retention: SAMPLES WITH DNA

Samples of lung tissue, saliva, blood, and scrapings from inside of cheek. Fluid and mucous collected during bronchoscopies.

MeSH Terms

Conditions

Head and Neck Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Smoking Cessation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Health Behavior; Behavior

Study Officials

• George Simon, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2006
• First Posted: July 14, 2006
• Study Start: August 1, 2004
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 3, 2016

Record last verified: 2016-02

Locations

US (3)