Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Organ Preservation in the Multispeciality Therapy of Stage II-IV Locally Advanced Head and Neck Cancer

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: NCT01187472
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : January 16, 2013
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This protocol was opened to collect long term survival information on subjects enrolled in a previous study which evaluated the impact of neoadjuvant chemotherapy and concomitant chemoradiotherapy with organ preserving optional surgery on overall survival, time to progression, pattern of disease recurrence in patient with locally advanced head and neck cancer. The last surviving subject was last treated in 1989, and was lost to follow up in 2010.

Condition or disease
Head and Neck Cancer

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 35 participants
Time Perspective: Prospective
Official Title: Organ Preservation in the Multispeciality Therapy of Stage II-IV Locally Advanced Head and Neck Cancer
Study Start Date : March 2003
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Treated subjects
Subjects treated on a previous study of locally advanced head and neck cancer


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Overall survival [ Time Frame: Until Death ]
    To collect long term survival information on subjects treated on a previous protocol which evaluated the the impact of neoadjuvant chemotherapy and concomitant chemoradiotherapy with organ preserving optional surgery on overall survival, time to progression, and pattern of disease recurrence in patients with locally advanced head and neck cancer.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:   59 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects enrolled on a previous head and neck cancer treatment protocol
Criteria

Eligibility Criteria:

Eligibility Criteria:

Subjects previously enrolled in a treatment protocol for locally advanced head and neck cancer who met the following criteria:

  1. Patients with Stage IV carcinoma of the nasal or oral cavity, nasopharynx pharynx, larynx, paranasal sinuses, cervical esophagus, or hypopharynx are eligible. Patients with Stage III carcinoma of the nasopharynx, base of tongue and hypopharynx are also eligible. Therapy is given with curative intent.

    Prior to entry in the study the resectability and standard treatment options for each patient will be determined during a joint evaluation by a team composed of an attending surgeon, a radiation oncologist and a medical oncologist. In addition the timing and feasibility of surgery will be determined in each patient prior to initiation of therapy. The unequivocal demonstration of distant metastasis confers in eligibility.

  2. Measurable disease is not required, but all disease will be carefully evaluated.
  3. Patients must have a histologically or cytologically confirmed diagnosis of squamous cell carcinoma, mucoepidermoid carcinoma or lymphoepithelioma.
  4. Patients must have not received prior chemotherapy or radiotherapy.
  5. Patients must have performance status of >60%
  6. Patients must have a WBC count of >3.5, an ANC count >1500 and a platlet count of >100,000.
  7. The serum creatinine must be equal to or less than 1.5 m/dlor the calculated creatinine clearance must exceed 50cc/min.
  8. Patient must be free of significant infection or other severe complicating medical illness.
  9. Pregnancy will constitute an absolute contraindication to entrance on this protocol.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01187472


Locations
Layout table for location information
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60653
Sponsors and Collaborators
University of Chicago
Investigators
Layout table for investigator information
Principal Investigator: Everett E Vokes, MD University of Chicago
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01187472    
Other Study ID Numbers: 12145B
First Posted: August 24, 2010    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013
Keywords provided by University of Chicago:
Head
neck
cancer
advanced
 oral cavity
lip
larynx
Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms