Status:
COMPLETED
Organ Preservation in the Multispeciality Therapy of Stage II-IV Locally Advanced Head and Neck Cancer
Lead Sponsor:
University of Chicago
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
59+ years
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 wit...
Eligibility Criteria
Inclusion
- Eligibility Criteria:
- Eligibility Criteria:
- Subjects previously enrolled in a treatment protocol for locally advanced head and neck cancer who met the following criteria:
- 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.
- Measurable disease is not required, but all disease will be carefully evaluated.
- Patients must have a histologically or cytologically confirmed diagnosis of squamous cell carcinoma, mucoepidermoid carcinoma or lymphoepithelioma.
- Patients must have not received prior chemotherapy or radiotherapy.
- Patients must have performance status of \>60%
- Patients must have a WBC count of \>3.5, an ANC count \>1500 and a platlet count of \>100,000.
- The serum creatinine must be equal to or less than 1.5 m/dlor the calculated creatinine clearance must exceed 50cc/min.
- Patient must be free of significant infection or other severe complicating medical illness.
- Pregnancy will constitute an absolute contraindication to entrance on this protocol.
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01187472
Start Date
March 1 2003
End Date
December 1 2010
Last Update
November 29 2023
Active Locations (1)
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1
The University of Chicago
Chicago, Illinois, United States, 60653