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Selective IMRT for Locally Advanced Head and Neck Carcinoma With Concurrent Panitumumab

Phase 2
18 Years
Not Enrolling
Head and Neck Cancer

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Trial Information

Selective IMRT for Locally Advanced Head and Neck Carcinoma With Concurrent Panitumumab

This is a non-randomized phase II trial of targeted radiotherapy (RT) administered
concurrently with panitumumab in patients with locally advanced squamous cell carcinoma of
the head and neck. This protocol addresses patients with medical comorbidities that make
them poor candidates for concurrent chemotherapy. Radiotherapy treatment will be directed
at disease visible on diagnostic imaging modalities and the ipsilateral hemi-neck, sparing
elective regions in the contralateral N0 hemi-neck with less than 20% chance of microscopic
involvement. We explore the following hypothesis: Can acceptable locoregional disease
control be obtained with less treatment-related morbidity by focusing RT on regions of gross
disease, sparing regions with a low risk of harboring subclinical disease from elective RT?

Inclusion Criteria:

- Histologically proven primary squamous cell carcinoma arising in the oral cavity,
oropharynx, hypopharynx, or larynx.

- Stage III, IVA, or IVB disease (locally advanced with no systemic metastases and
without bilateral nodal disease, i.e., N2c).

- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 with a life
expectancy >12 months.

- Patients are eligible if they have concurrent medical conditions that render them
poor candidates for chemotherapy. Patients are considered to be in this group if any
of the following criteria is met: Serum creatinine >1.5 mg/dl (or estimated
creatinine clearance <50mL/min); Insulin dependent diabetes; SGOT, SGPT, or alkaline
phosphatase >2.5 x upper limit of normal; History of significant CAD (myocardial
infarction [MI], coronary artery bypass graft [CABG], coronary stents, symptomatic
angina); Congestive heart failure [CHF] (LVEF <40% by echocardiogram or MUGA);
nephropathy; Prior history of malignancy treated with chemotherapy; Severe chronic
obstructive pulmonary disease [COPD], defined as FEV1 <1L; In the opinion of the
treating physician, patient would not tolerate the administration of concurrent
chemotherapy and radiation

- Age >18 years.

- The patient is medically fit to tolerate a course of definitive RT.

- The patient has adequate hematologic function defined as: absolute neutrophil count
>1000/ml, hematocrit >24%, and platelet count >50,000/ml. Patients with hematocrit
between 20% and 24% should undergo transfusion, and may be enrolled provided their
hematocrit reaches >24%.

- The patient may have had a prior malignancy but must be disease-free for three years
prior to study entry. A history of superficial non-melanoma skin cancer or in situ
carcinoma of the cervix less than three years will be allowed.

- The patient must agree to use effective contraception if childbearing potential
exists and continue contraception for at least 6 months following completion of the

- Evaluation by dental services prior to initiation of radiation therapy.

- Patient must be informed of the investigational nature of the study and sign an
informed consent form.

Exclusion Criteria:

- The patient has received radiation therapy previously to the head and neck. NOTE:
Previous radiotherapy for skin cancers of the head and neck are permitted if the
fields do not overlap significantly.

- All gross disease has been surgically resected. NOTE: Patients who have had an
excisional neck biopsy will not be eligible.

- Patient with positive contralateral neck node whether ipsilateral neck is negative or

- The patient is pregnant or lactating.

- Squamous cell carcinoma arising in the nasopharynx, sinuses, salivary glands, or the
primary is unknown.

- Non-squamous histologies (such as adenoid cystic or mucoepidermoid carcinoma).

- Spindle cell squamous carcinoma or mixed carcinoma/sarcoma.

- Scleroderma or active connective tissue disorder (Lupus).

- Any underlying psychological condition that would prohibit the understanding and
rendering of informed consent.

- Major surgery <3 weeks prior to study entry.

- History of interstitial lung disease, e.g., pulmonary fibrosis or interstitial

Type of Study:


Study Design:

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

Outcome Measure:

Recurrence Rate of Locally Advanced Head & Neck Cancer

Outcome Description:

Imaging for recurrence via CT scan will occur at 8 weeks (+/-5 days) post-RT, and will be repeated at 6, 9, 12, and 24 months from start of treatment.

Outcome Time Frame:

2 Years

Safety Issue:


Principal Investigator

Neil Hayes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill


United States: Food and Drug Administration

Study ID:

LCCC 1017



Start Date:

December 2011

Completion Date:

December 2018

Related Keywords:

  • Head and Neck Cancer
  • Head and neck cancer
  • Phase II
  • Locally advanced
  • Panitumumab
  • Vectibix
  • Lineberger
  • Radiation Therapy
  • Intensity modulated radiation therapy (IMRT)
  • Stage III to IVB
  • Carcinoma
  • Head and Neck Neoplasms
  • Carcinoma, Squamous Cell