Carcinoma of Unknown PrimaryNCT00388024
PET Scans and CT Scans in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy
An observational study of Carcinoma of Unknown Primary and Head and Neck Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
RATIONALE: Imaging procedures, such as PET scan and CT scan, may help doctors predict a patient's response to treatment and plan the best treatment. PURPOSE: This clinical trial is studying how well PET scans and CT scans show response to treatment in patients with locally advanced head and neck cancer undergoing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma of Unknown Primary, Head and Neck Cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jan 2015
- 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: primary care clinic
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed squamous cell carcinoma or lymphoepithelioma of the head and neck, including any of the following sites:
- Oral cavity
- Oropharynx
- Hypopharynx
- Larynx
- Nasopharynx
- Unknown primary of the head and neck region
- Stage III or IV disease
- Definitive chemoradiotherapy with curative intent must be planned
PATIENT CHARACTERISTICS:
- Able to tolerate positron emission tomography (PET) imaging
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No poorly controlled diabetes mellitus (e.g., fasting glucose > 200 mg/dL) despite medication
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy to head and neck
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: A Pilot Feasibility Study of PET-CT Imaging in Patients With Cancer of the Head and Neck Treated With Definitive Chemoradiation
RATIONALE: Imaging procedures, such as PET scan and CT scan, may help doctors predict a patient's response to treatment and plan the best treatment.
PURPOSE: This clinical trial is studying how well PET scans and CT scans show response to treatment in patients with locally advanced head and neck cancer undergoing chemotherapy and radiation therapy.
Read the detailed description
OBJECTIVES:
Primary
- Determine the feasibility of performing positron emission tomography-computed tomography (PET-CT) imaging for early discrimination of treatment response and post-therapy neck management in patients with locally advanced cancer of the head and neck treated with definitive chemoradiotherapy.
Secondary
- Perform semiquantitative analysis of tracer uptake in these patients using standard uptake values and qualitative analysis of tracer uptake using pure visual analysis.
- Determine the feasibility of distinguishing benign from malignant processes during initial tumor staging of these patients by whole-body PET-CT imaging.
- Correlate staging by whole-body PET-CT imaging with staging by standard CT/MRI, clinical exam, and pathologic specimen.
- Determine the feasibility of PET-CT imaging in these patients in treatment position for radiotherapy treatment planning, correlate the results with standard CT/MRI images, and record the differences.
- Perform PET-CT imaging in these patients during weeks 2 and 4 of chemoradiotherapy to evaluate the predictive value of response to treatment at these time points.
- Determine if the time interval for treatment monitoring at 6 and 12 weeks post chemoradiotherapy is important for the predictive value of PET-CT imaging.
- Evaluate patients with clinical or radiographic abnormalities worrisome for residual or recurrent disease with PET-CT imaging at 6 and 12 weeks post chemoradiotherapy to assess the need for additional therapies (i.e., neck dissection).
OUTLINE: This is a pilot study.
Patients receive fludeoxyglucose F 18 (FDG) IV over 90 seconds prior to the initial scan. Patients undergo whole-body computed tomography (CT) imaging with contrast followed by positron emission tomography (PET) imaging (approximately 1 hour after FDG injection) for initial staging and simulation for radiotherapy treatment planning. After PET-CT evaluation, patients with locoregional disease are recommended for standard-care chemoradiotherapy. Patients with evidence of M1 disease that is confirmed by CT/MRI and/or biopsy are treated at the discretion of the attending clinician. During chemoradiotherapy, patients undergo PET-CT imaging, as described above, at the beginning of week 2 and during week 4 for treatment monitoring and early detection of recurrent or residual disease. Follow-up PET-CT scans are performed, as described previously, at 6 weeks and then at 3 months after completion of chemoradiotherapy.
After completion of study procedures, patients are followed periodically for up to 5 years.
- Conditions
- Carcinoma of Unknown Primary, Head and Neck Cancer
- Keywords
- stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the oropharynx, stage III lymphoepithelioma of the nasopharynx, stage III lymphoepithelioma of the oropharynx, squamous cell carcinoma of unknown primary, newly diagnosed carcinoma of unknown primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma, untreated metastatic squamous neck cancer with occult primary, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the nasopharynx, stage IV lymphoepithelioma of the oropharynx
- Medical subject headings
- Neoplasms, Unknown Primary, Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cancer patients about to be treated with radiation therapy | Patienta with histologically confirmed squamous cell or lymphoepithelioma of oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, or unknown primary of the head and neck about to be treated with radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic value of positron emission tomography-computed tomography imaging in predicting clinical response at baseline, at weeks 2 and 4, and at week 6 post chemoradiotherapy
The results of the experimental scans will be compared to the response to radiation therapy as measured by routine scans at 6 weeks and 3 months after completion of therapy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startFeb 2006
- Primary completionDec 2008
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma of Unknown PrimaryStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathryn M. Greven, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388024
- Sponsor's protocol ID
- CDR0000504047
- Other IDs
- CCCWFU-60A05, CCCWFU-BG06-007
- Status last verified
- Feb 2017
- First submitted
- 12 Oct 2006
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of PET-CT Imaging in Patients With Cancer of the Head and Neck Treated With Definitive Chemoradiation
- ClinicalTrials.gov ID
- NCT00388024
- Acronym / sponsor ID
- CDR0000504047
- Conditions
- Carcinoma of Unknown Primary, Head and Neck Cancer
- Keywords
- stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the oropharynx, stage III lymphoepithelioma of the nasopharynx, stage III lymphoepithelioma of the oropharynx, squamous cell carcinoma of unknown primary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 13 Oct 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.
RATIONALE: Imaging procedures, such as PET scan and CT scan, may help doctors predict a patient's response to treatment and plan the best treatment.
PURPOSE: This clinical trial is studying how well PET scans and CT scans show response to treatment in patients with locally advanced head and neck cancer undergoing chemotherapy and radiation therapy.
Detailed description
OBJECTIVES:
Primary
- Determine the feasibility of performing positron emission tomography-computed tomography (PET-CT) imaging for early discrimination of treatment response and post-therapy neck management in patients with locally advanced cancer of the head and neck treated with definitive chemoradiotherapy.
Secondary
- Perform semiquantitative analysis of tracer uptake in these patients using standard uptake values and qualitative analysis of tracer uptake using pure visual analysis.
- Determine the feasibility of distinguishing benign from malignant processes during initial tumor staging of these patients by whole-body PET-CT imaging.
- Correlate staging by whole-body PET-CT imaging with staging by standard CT/MRI, clinical exam, and pathologic specimen.
- Determine the feasibility of PET-CT imaging in these patients in treatment position for radiotherapy treatment planning, correlate the results with standard CT/MRI images, and record the differences.
- Perform PET-CT imaging in these patients during weeks 2 and 4 of chemoradiotherapy to evaluate the predictive value of response to treatment at these time points.
- Determine if the time interval for treatment monitoring at 6 and 12 weeks post chemoradiotherapy is important for the predictive value of PET-CT imaging.
- Evaluate patients with clinical or radiographic abnormalities worrisome for residual or recurrent disease with PET-CT imaging at 6 and 12 weeks post chemoradiotherapy to assess the need for additional therapies (i.e., neck dissection).
OUTLINE: This is a pilot study.
Patients receive fludeoxyglucose F 18 (FDG) IV over 90 seconds prior to the initial scan. Patients undergo whole-body computed tomography (CT) imaging with contrast followed by positron emission tomography (PET) imaging (approximately 1 hour after FDG injection) for initial staging and simulation for radiotherapy treatment planning. After PET-CT evaluation, patients with locoregional disease are recommended for standard-care chemoradiotherapy. Patients with evidence of M1 disease that is confirmed by CT/MRI and/or biopsy are treated at the discretion of the attending clinician. During chemoradiotherapy, patients undergo PET-CT imaging, as described above, at the beginning of week 2 and during week 4 for treatment monitoring and early detection of recurrent or residual disease. Follow-up PET-CT scans are performed, as described previously, at 6 weeks and then at 3 months after completion of chemoradiotherapy.
After completion of study procedures, patients are followed periodically for up to 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cancer patients about to be treated with radiation therapy | – | –Patienta with histologically confirmed squamous cell or lymphoepithelioma of oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, or unknown primary of the head and neck about to be treated with radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognostic value of positron emission tomography-computed tomography imaging in predicting clinical response at baseline, at weeks 2 and 4, and at week 6 post chemoradiotherapy
Time frame: 3 months
The results of the experimental scans will be compared to the response to radiation therapy as measured by routine scans at 6 weeks and 3 months after completion of therapy
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 30 May 2017.
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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.
Kathryn M. Greven, MD study chair
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma of Unknown Primary and Head and Neck Cancer, run by Wake Forest University Health Sciences at 1 site 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?
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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Prognostic value of positron emission tomography-computed tomography imaging in predicting clinical response at baseline, at weeks 2 and 4, and at week 6 post chemoradiotherapy (time frame: 3 months). 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 30 May 2017.