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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187472
• Other study ID #: 12145B
• Status: Completed
• Start date: March 2003
• Est. completion date: December 2010

Study information

• Verified date: November 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 59 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	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.	Until Death