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Vanguard Study for Head and Neck Cancer or NSCLC Patients
This study is ongoing, but not recruiting participants.

First Received on July 12, 2006.   Last Updated on September 2, 2011   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: Department of Defense
Information provided by (Responsible Party): M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00352391
  Purpose

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.

Condition Intervention Phase
Head and Neck Cancer
Lung Cancer
Other: Assessments
Phase II

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Vanguard Study Characterizing Occurrence of Recurrent or Second Primary Tumors in Patients With Prior History of Definitively Treated Stage I/II Head and Neck or Non-Small Cell Lung Cancer Who Are Current or Former Smokers

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To look at how long individuals who have been treated for early stage NSCLC or HNSCC live without developing lung cancer. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To develop tools to help predict the likelihood of lung cancer occurrence in this population by studying characteristics of tissue and bodily fluids (including blood). [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 63
Study Start Date: August 2004
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with Head and Neck or Non-Small Cell Lung Cancer who are Current or Former Smokers.
Other: Assessments
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  1. 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).
  2. HNSCC patients:Definitive local treatment </= 12 months prior to trial enrollment. NSCLC patients: Surgery </= 12 months prior to trial enrollment.
  3. No evidence residual cancer
  4. Age > = 18 years
  5. Performance status of 0- 2 (Zubrod)
  6. Patients must have no contraindications for undergoing bronchoscopy.
  7. Patients must have no active pulmonary infections.
  8. 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 %.
  9. Participants must complete the pretreatment evaluation and must consent to bronchoscopy and to endobronchial biopsy for biomarker studies.
  10. 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.
  11. Smoking history of at least 10 pack years. May be current or former smoker.
  12. Subject must be considered legally capable of providing his or her own consent for participation in this study.
  13. HNSCC patients only: Must have no contraindications for undergoing laryngoscopy.

Exclusion Criteria:

  1. 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.
  2. History of systemic chemotherapy. Exception: NSCLC patients may have had up to 4 cycles of platinum-based doublet therapy.
  3. Pregnant or breast-feeding (a negative pregnancy test within 72 hours of enrollment for women with child-bearing potential is required).
  4. Participants with active pulmonary infections or recent history of pulmonary infection (within one month).
  5. Participants with acute intercurrent illness.
  6. Participants requiring chronic ongoing treatment with NSAIDs except aspirin.
  7. Participants with history of stroke, uncontrolled hypertension, and/or uncontrolled angina pectoris.
  8. Patients may not take high dose antioxidants (vitamins E or C) during the study period. "High dose" will be determined by the study investigators.
  9. 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.
  10. History of biologic therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352391

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Waun K. Hong, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00352391     History of Changes
Other Study ID Numbers: 2003-0424
Study First Received: July 12, 2006
Last Updated: September 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Non-Small Cell Lung Cancer
Head And Neck Cancer
Lung Cancer
Bronchoscopy
Laryngoscopy
NSCLC
Disease Free Survival
Current Smoker
Former Smoker

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Head and Neck Neoplasms
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012