Head and Neck CancerNCT00352391
Vanguard Study for Head and Neck Cancer or Non-Small Cell Lung Cancer (NSCLC) Patients
An observational study of Head and Neck Cancer and Lung Cancer, run by M.D. Anderson Cancer Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Lung Cancer
- What is being tested?
- Assessments
- How many people
- 54 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2004to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Conemaugh Memorial Medical Center
Johnstown, Pennsylvania, 15901
About this study
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
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.
Read the detailed description
This study is known as the Vanguard Trial. When you enter this study, you will have a complete medical history (including smoking history) and physical exam, including measurement of height, weight, and vital signs (including blood pressure, heart rate, and temperature). You will have a performance status evaluation (a test looking at the ability to perform every day activities). You will have blood samples drawn for routine blood tests (about 3 teaspoons), to check your blood clotting function (about 1-2 teaspoons), and for research purposes (about 4 teaspoons). You will have a chest x-ray and a CT scan of your chest. Women who are able to have children must have a negative blood or urine pregnancy test. If you are currently a smoker, you will be given information on programs to help you quit smoking. Although you will be encouraged to quit smoking, you do not have to quit smoking or participate in these programs to be a part of this study.
You will also have a bronchoscopy (tissue sample from the lung) at the beginning of this study for lab analysis. For this procedure, you will be given drugs to relax. Then, a local anesthetic will be sprayed in your nose and throat to numb those areas. A slim, flexible tube with a light will be placed through your nose or mouth and into your lungs. Tweezers will be fed through the tube to collect lung tissue (biopsy) samples from 6 different places in your lungs. During the bronchoscopy procedure, a complete inspection of the airways will be performed. Any suspicious areas that are seen under the white-light and autofluorescence bronchoscopy will be identified and more biopsies and brushings will be performed to evaluate whether any pre-cancerous tissue is present. You will also have a bronchial brushing next to each biopsy site. In a bronchial brushing, a small brush is fed through the tube into your lungs and a sample of lung tissue is gently scraped off. When the biopsies and brushings are done, you will have a bronchial lavage (bronchial washing). In the bronchial lavage, a small amount of water (about 4 tablespoons) is sprayed into your lungs and then suctioned out through the tube. This fluid is used to collect additional tissue and mucous samples. In addition, a sputum (saliva) sample will be taken and the inside of your cheek will be scraped (buccal sample).
If you have had HNSCC, you will also have a laryngoscopy. In a laryngoscopy, a lighted tube is placed down your throat and the larynx is checked. The back of your throat will be sprayed with an anesthetic before this procedure to make the procedure more comfortable.
While on study, you will return to the clinic for at least 3 years and for up to a total of 6 years. At Months 6, 12, 18, 24, 30, and 36, your complete medical history will be recorded, and you will have a physical exam by either a doctor or a nurse. At each of these visits, you will also have blood drawn for routine tests (about 3 teaspoons) and for research purposes (about 4 teaspoons). You will also have a chest x-ray and a chest CT at these visits. At Months 12, 24 and 36, you will have blood drawn (about 1-2 teaspoons) to check your blood-clotting function. If you think you may be pregnant, you will also have a urine or blood pregnancy test. In addition, you will have a bronchoscopy and provide sputum and buccal smear samples at your 12 month visit. If you have been treated for HNSCC you will have a laryngoscopy at 12 months.
You have the right to leave the study at any time. If you choose to stop participating in this study, you will be asked to return to the clinic for a final clinic visit. At this visit, your complete medical history will be recorded, and you will have a physical exam and blood drawn for routine tests (about 3 teaspoons) and for research purposes (about 4 teaspoons). Your study doctor will also ask you about your current smoking use, any medications you are taking, and how you are feeling (symptoms).
This research study includes two bronchoscopies done one year apart. These bronchoscopies are being done primarily for research purposes and are unlikely to provide information useful in your individual treatment. These bronchoscopies do have risks associated with them. These risks are described in section 4 of this informed consent document.
Recent research on early stage NSCLC indicates that adjuvant chemotherapy after surgery increases the length of time a person may survive and the length of time before cancer recurs. However, this adjuvant chemotherapy also has side effects that can be severe and in rare cases fatal. If you have had surgery for NSCLC and wish to receive adjuvant chemotherapy, you may only enroll in the Vanguard study after you have completed the adjuvant chemotherapy.
As part of this study you will provide samples of your lung tissue, saliva, blood, and scrapings from the inside of your cheek. Fluid and mucous collected during the bronchoscopies will also collected. These samples will be studied by scientists to learn about genes and proteins in people who have been treated for early NSCLC or HNSCC. The samples will also be used to grow cells and cultures that will be used to test chemotherapy drugs. These cells and cultures will also be used to learn about genes and proteins.
All M. D. Anderson researchers are trained in the importance of maintaining patient privacy. Your privacy will be protected by assigning you a number that will be used in place of your name on documents that are part of this study. A list that links your name with your study number will be stored in a restricted file that may be accessed only with a password. Only a few essential research personnel have access to this password.
At the end of the study you will not be automatically notified of the research findings. If you wish to learn about the results, however, you may request them from the principal investigator:
Principal Investigator: Waun Ki Hong, MD 1515 Holcombe Blvd., Unit 432 MD Anderson Cancer Center Houston, TX 77030
This is an investigational study. A total of about 50 individuals will take part in this study. Participants will be enrolled at M. D. Anderson and several other sites around the country.
- Conditions
- Head and Neck Cancer, Lung Cancer
- Being tested
- Assessments
- Keywords
- Non-Small Cell Lung Cancer, Head And Neck Cancer, Lung Cancer, Bronchoscopy, Laryngoscopy, NSCLC, Disease Free Survival, Current Smoker, Former Smoker
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Vanguard Study | Patients with Head and Neck or Non-Small Cell Lung Cancer who are Current or Former Smokers. Receives: Other: Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startAug 2004
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- George Simon, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352391
- Sponsor's protocol ID
- 2003-0424
- Status last verified
- Feb 2016
- First submitted
- 12 Jul 2006
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00352391
- Acronym / sponsor ID
- 2003-0424
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Aug 2004
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is known as the Vanguard Trial. When you enter this study, you will have a complete medical history (including smoking history) and physical exam, including measurement of height, weight, and vital signs (including blood pressure, heart rate, and temperature). You will have a performance status evaluation (a test looking at the ability to perform every day activities). You will have blood samples drawn for routine blood tests (about 3 teaspoons), to check your blood clotting function (about 1-2 teaspoons), and for research purposes (about 4 teaspoons). You will have a chest x-ray and a CT scan of your chest. Women who are able to have children must have a negative blood or urine pregnancy test. If you are currently a smoker, you will be given information on programs to help you quit smoking. Although you will be encouraged to quit smoking, you do not have to quit smoking or participate in these programs to be a part of this study.
You will also have a bronchoscopy (tissue sample from the lung) at the beginning of this study for lab analysis. For this procedure, you will be given drugs to relax. Then, a local anesthetic will be sprayed in your nose and throat to numb those areas. A slim, flexible tube with a light will be placed through your nose or mouth and into your lungs. Tweezers will be fed through the tube to collect lung tissue (biopsy) samples from 6 different places in your lungs. During the bronchoscopy procedure, a complete inspection of the airways will be performed. Any suspicious areas that are seen under the white-light and autofluorescence bronchoscopy will be identified and more biopsies and brushings will be performed to evaluate whether any pre-cancerous tissue is present. You will also have a bronchial brushing next to each biopsy site. In a bronchial brushing, a small brush is fed through the tube into your lungs and a sample of lung tissue is gently scraped off. When the biopsies and brushings are done, you will have a bronchial lavage (bronchial washing). In the bronchial lavage, a small amount of water (about 4 tablespoons) is sprayed into your lungs and then suctioned out through the tube. This fluid is used to collect additional tissue and mucous samples. In addition, a sputum (saliva) sample will be taken and the inside of your cheek will be scraped (buccal sample).
If you have had HNSCC, you will also have a laryngoscopy. In a laryngoscopy, a lighted tube is placed down your throat and the larynx is checked. The back of your throat will be sprayed with an anesthetic before this procedure to make the procedure more comfortable.
While on study, you will return to the clinic for at least 3 years and for up to a total of 6 years. At Months 6, 12, 18, 24, 30, and 36, your complete medical history will be recorded, and you will have a physical exam by either a doctor or a nurse. At each of these visits, you will also have blood drawn for routine tests (about 3 teaspoons) and for research purposes (about 4 teaspoons). You will also have a chest x-ray and a chest CT at these visits. At Months 12, 24 and 36, you will have blood drawn (about 1-2 teaspoons) to check your blood-clotting function. If you think you may be pregnant, you will also have a urine or blood pregnancy test. In addition, you will have a bronchoscopy and provide sputum and buccal smear samples at your 12 month visit. If you have been treated for HNSCC you will have a laryngoscopy at 12 months.
You have the right to leave the study at any time. If you choose to stop participating in this study, you will be asked to return to the clinic for a final clinic visit. At this visit, your complete medical history will be recorded, and you will have a physical exam and blood drawn for routine tests (about 3 teaspoons) and for research purposes (about 4 teaspoons). Your study doctor will also ask you about your current smoking use, any medications you are taking, and how you are feeling (symptoms).
This research study includes two bronchoscopies done one year apart. These bronchoscopies are being done primarily for research purposes and are unlikely to provide information useful in your individual treatment. These bronchoscopies do have risks associated with them. These risks are described in section 4 of this informed consent document.
Recent research on early stage NSCLC indicates that adjuvant chemotherapy after surgery increases the length of time a person may survive and the length of time before cancer recurs. However, this adjuvant chemotherapy also has side effects that can be severe and in rare cases fatal. If you have had surgery for NSCLC and wish to receive adjuvant chemotherapy, you may only enroll in the Vanguard study after you have completed the adjuvant chemotherapy.
As part of this study you will provide samples of your lung tissue, saliva, blood, and scrapings from the inside of your cheek. Fluid and mucous collected during the bronchoscopies will also collected. These samples will be studied by scientists to learn about genes and proteins in people who have been treated for early NSCLC or HNSCC. The samples will also be used to grow cells and cultures that will be used to test chemotherapy drugs. These cells and cultures will also be used to learn about genes and proteins.
All M. D. Anderson researchers are trained in the importance of maintaining patient privacy. Your privacy will be protected by assigning you a number that will be used in place of your name on documents that are part of this study. A list that links your name with your study number will be stored in a restricted file that may be accessed only with a password. Only a few essential research personnel have access to this password.
At the end of the study you will not be automatically notified of the research findings. If you wish to learn about the results, however, you may request them from the principal investigator:
Principal Investigator: Waun Ki Hong, MD 1515 Holcombe Blvd., Unit 432 MD Anderson Cancer Center Houston, TX 77030
This is an investigational study. A total of about 50 individuals will take part in this study. Participants will be enrolled at M. D. Anderson and several other sites around the country.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vanguard Study | – | Other: AssessmentsPatients with Head and Neck or Non-Small Cell Lung Cancer who are Current or Former Smokers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentsAt 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. | Other | Vanguard Study |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Simon, MD principal investigator
M.D. Anderson Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Lung Cancer, run by M.D. Anderson Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking-Related Disease-Free Survival (S-DFS) (time frame: 6 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.