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Image Guided Intensity Modulated Reirradiation With Concurrent Cetuximab in the Treatment of Locoregionally Confined Relapsed Squamous Cell Carcinoma of the Head and Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Squamous Cell Cancer of the Head and Neck

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Trial Information

Image Guided Intensity Modulated Reirradiation With Concurrent Cetuximab in the Treatment of Locoregionally Confined Relapsed Squamous Cell Carcinoma of the Head and Neck


Inclusion Criteria:



- Patients must have a pathologically confirmed recurrence (reappearance of previously
cleared) squamous cell cancer in the upper aerodigestive tract or a second squamous
cell primary. Patients may have experienced more than one recurrence as long as the
first recurrence occurred ≥6 months following the end of the prior RT.

- The recurrence or second primary must be confined to the head and neck above the
clavicles (loco-regional recurrence).

- The majority (≥75%) of the tumor volume must have been in areas previously irradiated
to ≥45 Gy. The previous irradiation must not exceed a maximum of 75 Gy.

- Patients must be at least 6 months from prior radiation therapy.

- If a resection is performed after the diagnosis of recurrence and before enrollment,
either microscopic or macroscopic disease must be present (i.e. positive margins or
gross residual).

- Karnofsky Performance Status 60-100.

- Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, bilirubin ≤ 1.5 mg/dl, creatinine ≤
1.5 mg/dl, within 6 weeks prior to registration.

- Must be able to submit previous radiation records (simulation and portal film if
available) in order to assure that cord tolerance is not exceeded.

- Patients must sign a study-specific informed consent form prior to study entry.

- The patient must be between the ages of 18 and 75.

Exclusion Criteria:

- Distant metastases.

- Completely resected recurrence with negative margins.

- Other concurrent invasive malignancies.

- Prior invasive malignancy unless disease free for at least two years (prior in situ
malignancies are permissible).

- Intercurrent medical illnesses which would impair patient tolerance to therapy or
limit survival.

- Pregnant and nursing women are excluded because of the potential teratogenic effects
and potential unknown effects on nursing newborns.

- Previous treatment with cetuximab.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To estimate the incidence rate of acute and late toxicities associated with combined cetuximab and image guided intensity modulated reirradiation in patients with recurrent squamous cell cancer of the head and neck.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Heath B Mackley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State Hershey Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

PSHCI 08-066

NCT ID:

NCT00934518

Start Date:

July 2009

Completion Date:

Related Keywords:

  • Squamous Cell Cancer of the Head and Neck
  • Squamous cell carcinoma, Head and Neck cancer
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Penn State Hershey Cancer Institute Hershey, Pennsylvania  17033