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Phase III Randomized Study of Standard Fractionation Radiotherapy and High-Dose Cisplatin Versus Accelerated Fractionation Radiotherapy and Panitumumab in Patients With Locally Advanced Stage III or IV Squamous Cell Carcinoma of the Head and Neck
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Radiation Therapy and Cisplatin or Panitumumab in Treating Patients With Locally Advanced Stage III or Stage IV Head and Neck Cancer
Basic Trial Information
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Protocol IDs
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Phase III
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Treatment
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Active
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18 and over
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Other
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CAN-NCIC-HN6 HN6, NCT00820248
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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.
Entry Criteria Disease Characteristics:
- Histologically 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
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
Patient Characteristics:
- ECOG performance status 0-1
- Absolute granulocyte count ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/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 psychotic disorder
- Active serious infection
- Active peptic ulcer disease
- Any other medical condition that might interfere with protocol therapy delivery
Expected Enrollment 320Outcomes Primary Outcome(s)Progression-free survival (PFS)
Secondary Outcome(s)Overall survival Local and regional PFS Distant metastasis Adverse events, including late radiotherapy-related adverse events as assessed by NCI CTCAE v3.0 Quality of life (QOL) Swallowing-related (QOL) Economic evaluation, including healthcare utilization, health utilities, 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.
Trial Contact Information
Trial Lead Organizations NCIC-Clinical Trials Group | | | Lillian Siu, MD, FRCPC, Principal investigator | | | | John Waldron, MD, Protocol co-chair | | | | Trial Sites
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Canada |
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Ontario |
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Toronto |
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| | | | Princess Margaret Hospital |
| | Lillian Siu | |
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Registry Information | | Official Title | | 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 | | Trial Start Date | | 2008-12-31 (estimated) | | Trial Completion Date | | 2012-03-31 (estimated) | | Registered in ClinicalTrials.gov | | NCT00820248 | | Date Submitted to PDQ | | 2008-12-10 | | Information Last Verified | | 2009-01-14 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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