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Status:

WITHDRAWN

Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients Who Have Undergone Surgery for Advanced Hypopharyngeal Cancer, Oropharyngeal Cancer, Laryngeal Cancer, or Oral Cavity Cancer at High Risk of Recurrence

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Conditions:

Head and Neck Cancer

Eligibility:

All Genders

18-75 years

Phase:

PHASE3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radi...

Detailed Description

OBJECTIVES: Primary * To determine if the addition of concurrently administered panitumumab to standard adjuvant chemoradiation, with 1 of 2 cisplatin-based regimens, significantly prolongs disease-...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed primary squamous cell carcinoma of the hypopharynx, oropharynx, larynx, or oral cavity
  • Stage pT1-2 pN+ or pT3-4 any pN (stage III-IVB) disease
  • No distant metastases
  • No recurrent disease
  • Resectable disease
  • Has undergone surgical resection of carcinoma
  • p16 immunohistochemistry assay performed on tissue sections taken during the surgical procedure
  • No laser surgery
  • Potentially at high-risk of locoregional recurrence, defined as fulfilling ≥ 1 of the following criteria:
  • Close surgical margins (i.e., margins 1 mm to \< 5 mm)
  • R1-resection (\< 1 mm) (R2 resection is considered as not eligible)
  • Extracapsular nodal extension
  • No nasopharynx, nasal cavity, or paranasal sinuses carcinomas
  • PATIENT CHARACTERISTICS:
  • WHO or ECOG performance status 0-1
  • Absolute neutrophils ≥ 1.5 x 10\^9/L
  • Platelet count ≥ 100 x 10\^9/L
  • Hemoglobin ≥ 10.0 g/dL
  • Bilirubin \< 1.5 times upper limit of normal (ULN)
  • AST\< 3 times ULN
  • Alkaline phosphatase \< 3 times ULN
  • Calculated creatinine clearance ≥ 60 mL/min
  • Calcium ≤ 11.5 mg/dL or 2.9 mmol/L
  • Magnesium ≥ 1.2 mg/dL or 0.5 mmol/L
  • Fertile patients must use effective contraception methods during the study and for 6 months after the last treatment dose
  • Not pregnant or nursing
  • No known allergic or hypersensitivity reaction to any of the components of the study treatment
  • No other concurrent serious illnesses or medical conditions, including any of the following:
  • History or evidence of interstitial pneumonitis or pulmonary fibrosis
  • Unstable cardiac disease despite treatment
  • NYHA class III-IV congestive heart failure
  • Clinically significant abnormal ECG or LVEF below the institutional lower limit of normal
  • Known HIV infection or other conditions of persistent immunodeficiency
  • Significant neurologic or psychiatric disorders
  • Active uncontrolled infection
  • Active disseminated intravascular coagulation
  • Symptomatic peripheral neuropathy (CTCAE 4.0 "peripheral sensory neuropathy and paresthesia") ≥ grade 2 or ototoxicity (CTCAE 4.0 "hearing impaired") ≥ grade 2, unless due to trauma or mechanical impairment due to tumor mass
  • Other serious underlying medical conditions that could impair the ability of the patient to participate in the study
  • No other malignancy within the past 5 years other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix
  • Patients who are disease-free for \> 5 years allowed
  • No known drug abuse
  • No psychological, familial, sociological (e.g., severe alcohol addiction expected to hamper protocol compliance), or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • PRIOR CONCURRENT THERAPY:
  • No prior chemotherapy or radiotherapy for carcinoma of the head and neck
  • No prior radiotherapy to the head and neck region
  • No prior exposure to EGFR pathway-targeting therapy
  • No participation in another interventional clinical trial within the past 30 days
  • No concurrent granulocyte colony-stimulating factor (G-CSF) or erythropoietin
  • No other concurrent investigational drugs and/or anticancer treatment

Exclusion

    Key Trial Info

    Start Date :

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT01142414

    Last Update

    January 16 2012

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