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

Phase 2
59 Years
Not Enrolling
Head and Neck Cancer

Thank you

Trial Information

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

Inclusion 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

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

9. Pregnancy will constitute an absolute contraindication to entrance on this protocol.

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Overall survival

Outcome Description:

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.

Outcome Time Frame:

Until Death

Safety Issue:


Principal Investigator

Everett E Vokes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Institutional Review Board

Study ID:




Start Date:

March 2003

Completion Date:

December 2010

Related Keywords:

  • Head and Neck Cancer
  • Head
  • neck
  • cancer
  • advanced
  • oral cavity
  • lip
  • larynx
  • Head and Neck Neoplasms



The University of Chicago Chicago, Illinois  60637