PET Scans and CT Scans in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy

NCT00388024 | Completed

• 3 other identifiers: CDR0000504047CCCWFU-60A05CCCWFU-BG06-007
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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 chemotherapy and radiation therapy.

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

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Study Arms (1)

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

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Neoplasms, Unknown Primary; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Kathryn M. Greven, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 12, 2006
• First Posted: October 13, 2006
• Study Start: February 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2015
• Last Updated: May 30, 2017

Record last verified: 2017-02

Locations

US (1)