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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-03-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Treated subjects

Subjects treated on a previous study of locally advanced head and neck cancer

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Everett E Vokes, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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12145B

Identifier Type: -

Identifier Source: org_study_id