Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00352391
Recruitment Status : Completed
First Posted : July 14, 2006
Last Update Posted : February 3, 2016
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
Head and Neck Cancer Lung Cancer Other: Assessments

  Show Detailed Description

Layout table for study information
Study Type : Observational
Actual Enrollment : 54 participants
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
Study Start Date : August 2004
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Vanguard Study
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.




Primary Outcome Measures :
  1. Smoking-Related Disease-Free Survival (S-DFS) [ Time Frame: 6 Years ]
    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.


Biospecimen Retention:   Samples With DNA
Samples of lung tissue, saliva, blood, and scrapings from inside of cheek. Fluid and mucous collected during bronchoscopies.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352391


Locations
Layout table for location information
United States, Georgia
Eisenhower Army Medical Center
Fort Gordon, Georgia, United States, 30905
United States, Pennsylvania
Conemaugh Memorial Medical Center
Johnstown, Pennsylvania, United States, 15901
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
United States Department of Defense
Investigators
Layout table for investigator information
Principal Investigator: George Simon, MD M.D. Anderson Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00352391     History of Changes
Other Study ID Numbers: 2003-0424
First Posted: July 14, 2006    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016
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:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Head and Neck Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms