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A Phase III Study of Standard Fractionation Radiotherapy With Concurrent High-Dose Cisplatin Versus Accelerated Fractionation Radiotherapy With Panitumumab in Patients With Locally Advanced Stage III and IV Squamous Cell Carcinoma of the Head and Neck


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

A Phase III Study of Standard Fractionation Radiotherapy With Concurrent High-Dose Cisplatin Versus Accelerated Fractionation Radiotherapy With Panitumumab in Patients With Locally Advanced Stage III and IV Squamous Cell Carcinoma of the Head and Neck


OBJECTIVES:

Primary

- To compare the progression-free survival (PFS) of patients with locally advanced
squamous cell carcinoma of the head and neck treated with standard fractionation
radiotherapy and high-dose cisplatin vs accelerated fractionation radiotherapy and
panitumumab.

Secondary

- To compare overall survival of patients treated with these regimens.

- To compare local and regional PFS of patients treated with these regimens.

- To compare distant metastasis in patients treated with these regimens.

- To compare adverse events, including late radiotherapy-related adverse events in
patients treated with these regimens.

- To compare quality of life (QOL) of patients treated with these regimens.

- To compare swallowing-related QOL of patients treated with these regimens.

- To compare economic evaluation (cost effectiveness analysis and cost utility),
including both healthcare utilization and indirect costs.

OUTLINE: This is a multicenter study. Patients are stratified according to T category (T1-3
vs T4), nodal status (N0-1 vs N2 vs N3), radiotherapy delivery modality (intensity-modulated
[IMRT] vs 3-D conformal [3D CRT]), anatomic location (hypopharynx vs oral cavity vs
oropharynx vs larynx), and participation in the optional swallowing impairment substudy (yes
vs no). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once
daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1,
22, and 43 of radiotherapy.

- Arm II: Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once
or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90
minutes 1 week prior to and on days 15 and 36 of radiotherapy.

Treatment in both arms continues in the absence of disease progression or unacceptable
toxicity.

Quality of life (QOL) (FACT-H&N), swallowing-related QOL (MDADI, SWAL-QOL), swallowing
function (FOIS), and economic evaluations (Lost Productivity questionnaire) are assessed
periodically during the study.

After completion of study treatment, patients are followed periodically for at least 5
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically and/or cytologically confirmed (primary lesion or regional lymph
nodes) squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx

- Locally advanced disease, defined by any of the following criteria:

- Any T, N+, M0

- T3-4, N0, M0

- No current history of unknown primary squamous cell carcinoma of the head and neck,
primary nasopharyngeal, paranasal, or salivary gland tumors of the head and neck

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Absolute granulocyte count ≥ 1.5 x 10^9/L

- Platelet count ≥ 100 x 10^9/L

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST or ALT ≤ 3 times ULN

- Creatinine clearance > 50 mL/min

- Magnesium > 0.5 mmol/L

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 6 months after
completion of study treatment

- Must be accessible for treatment and follow-up

- Able (sufficiently fluent) and willing to complete the quality of life (QOL) and
swallowing QOL questionnaires in either English or French

- Must be assessed by a radiation oncologist and medical oncologist and deemed suitable
for study participation

- No other malignancies within the past 5 years, except adequately treated nonmelanoma
skin cancer, curatively treated in-situ cancer of the cervix, or other curatively
treated solid tumors

- No history of allergic or hypersensitivity reactions to any of the study drugs or
their excipients

- No prior or concurrent interstitial lung disease (e.g., pneumonitis or pulmonary
fibrosis) on baseline CT scan

- No peripheral neuropathy ≥ grade 2 (CTCAE v3.0)

- No hearing loss/tinnitus ≥ grade 3 (CTCAE v3.0)

- No thromboembolic event within the past 12 months despite being treated with
anticoagulation drugs

- Prior thromboembolic event > 12 months allowed provided patient is stable on
anticoagulation or on preventative anticoagulation

- None of the following allowed:

- Myocardial infarction within the past 12 months

- Uncontrolled severe congestive heart failure

- Unstable angina

- Active cardiomyopathy

- Unstable ventricular arrhythmia

- Uncontrolled hypertension

- Uncontrolled psychiatric disorder

- Active serious infection

- Active peptic ulcer disease

- Any other medical condition that might interfere with protocol therapy delivery

PRIOR CONCURRENT THERAPY:

- No prior surgical treatment except diagnostic biopsy for this disease

- No prior induction chemotherapy for this disease

- No prior radiation to the head and neck region that would result in overlap of fields
for this study

- No prior cisplatin or carboplatin chemotherapy

- No prior targeted anti-EGFR therapy of any kind

- At least 30 days since any prior investigational agent

- No concurrent granulocytic growth factors (e.g., filgrastim [G-CSF]) during
radiotherapy

- No concurrent erythropoietic growth factors, pilocarpine, amifostine, other
anticancer therapy (e.g., cytotoxic agents, biological response modifiers,
immunotherapy, or hormonal therapy), or other investigational drug therapy

- The following radiological investigations must be done within 8 weeks of
randomization:

- MRI or CT of the head and neck

- CT chest

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

6.2 years

Safety Issue:

No

Principal Investigator

Lillian L. Siu, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Health Canada

Study ID:

HN6

NCT ID:

NCT00820248

Start Date:

December 2008

Completion Date:

March 2016

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage III verrucous carcinoma of the larynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV verrucous carcinoma of the larynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage III verrucous carcinoma of the oral cavity
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV verrucous carcinoma of the oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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