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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01187472
First received: August 20, 2010
Last updated: January 15, 2013
Last verified: January 2013

August 20, 2010
January 15, 2013
March 2003
December 2010   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: Until Death ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT01187472 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Organ Preservation in the Multispeciality Therapy of Stage II-IV Locally Advanced Head and Neck Cancer
Organ Preservation in the Multispeciality Therapy of Stage II-IV Locally Advanced Head and Neck Cancer

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects enrolled on a previous head and neck cancer treatment protocol

Head and Neck Cancer
Not Provided
Treated subjects
Subjects treated on a previous study of locally advanced head and neck cancer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
59 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01187472
12145B
No
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Everett E Vokes, MD University of Chicago
University of Chicago
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP