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Status:

COMPLETED

Radiation + Cisplatin or Panitumumab in Locally Advanced Stage III or Stage IV Head and Neck Cancer

Lead Sponsor:

NCIC Clinical Trials Group

Conditions:

Head and Neck Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. ...

Detailed Description

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 a...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    December 30 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 17 2017

    Estimated Enrollment :

    320 Patients enrolled

    Trial Details

    Trial ID

    NCT00820248

    Start Date

    December 30 2008

    End Date

    February 17 2017

    Last Update

    August 22 2023

    Active Locations (19)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 5 (19 locations)

    1

    Cross Cancer Institute

    Edmonton, Alberta, Canada, T6G 1Z2

    2

    BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, Canada, V3V 1Z2

    3

    BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, Canada, V5Z 4E6

    4

    CancerCare Manitoba

    Winnipeg, Manitoba, Canada, R3E 0V9