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A Feasibility Study of Re-irradiation Using Stereotactic Body Radiation Therapy (SBRT) and Cetuximab for Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)


N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

A Feasibility Study of Re-irradiation Using Stereotactic Body Radiation Therapy (SBRT) and Cetuximab for Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)


OBJECTIVES:

Primary

- To assess the toxicity of stereotactic body radiotherapy delivered concurrently with
cetuximab in patients with recurrent squamous cell carcinoma of the head and neck.

Secondary

- To assess the feasibility of delivering this regimen in these patients.

- To assess the impact of this regimen on local control, distant control, and overall
survival of these patients.

OUTLINE: Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5.
Patients undergo 1 fraction of stereotactic-body radiotherapy (RT) in week 2. At 4 weeks
after RT completion, patients may receive additional cetuximab IV combined with a 28-day
chemotherapy regimen, per investigator discretion.

After completion of study treatment, patients are followed every 2 months for 1 year, every
3-4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma of the oral cavity, paranasal
sinuses, nasopharynx, larynx, hypopharynx, or oropharynx

- Medically or surgically inoperable disease or patient refuses surgery

- Recurrent disease

- Previously irradiated disease meeting the following criteria:

- Prior radiotherapy completed > 6 months from re-irradiation

- Prior radiotherapy in the region of the study cancer that would result in
overlap of radiation therapy fields

- Majority of the recurrent tumor volume (> 50%) received prior radiotherapy dose
of 30-75 Gy

- No distant metastatic disease

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy ≥ 3 months

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 60 days after
completion of study treatment

- No prior allergic reaction to study drugs

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior surgical resection of the recurrent primary tumor and/or regional lymphatics

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Grade 4-5 toxicity as assessed by NCI CTCAE v.30

Outcome Time Frame:

Daily while on Treatment

Safety Issue:

Yes

Principal Investigator

Anurag K. Singh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000640992

NCT ID:

NCT00891904

Start Date:

April 2009

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • recurrent squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263