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A Multicenter Phase II Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer


Phase 2
59 Years
N/A
Not Enrolling
Both
Head and Neck

Thank you

Trial Information

A Multicenter Phase II Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer

Inclusion Criteria


Eligibility 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 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.
Females of child-bearing age should be using adequate contraception.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rates

Outcome Description:

To evaluate the activity of 5 cycles of C-FHX/G-CSF in previously untreated patients with stage II and IV locoregionally advanced head and neck cancer.

Outcome Time Frame:

2-5 years

Safety Issue:

No

Principal Investigator

Everett Vokes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Chicago Medical Center

Authority:

United States: Institutional Review Board

Study ID:

12141B

NCT ID:

NCT01693718

Start Date:

March 2003

Completion Date:

September 2004

Related Keywords:

  • Head and Neck
  • cancer
  • advanced
  • oral cavity
  • larynx
  • Head and Neck Neoplasms

Name

Location

The University of ChicagoChicago, Illinois  60637