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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00820248
Recruitment Status : Completed
First Posted : January 12, 2009
Results First Posted : June 20, 2017
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

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. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving standard radiation therapy together with high-dose cisplatin is more effective than giving higher-dose radiation therapy together with panitumumab in treating patients with locally advanced head and neck cancer.

PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens to see how well they work when given together with cisplatin or panitumumab in treating patients with locally advanced stage III or stage IV head and neck cancer.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Biological: panitumumab Drug: cisplatin Radiation: 3-dimensional conformal radiation therapy Radiation: accelerated radiation therapy Radiation: intensity-modulated radiation therapy Phase 3

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 18, 2008
Actual Primary Completion Date : May 16, 2015
Actual Study Completion Date : February 17, 2017


Arm Intervention/treatment
Active Comparator: 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.
Drug: cisplatin
Given IV

Radiation: 3-dimensional conformal radiation therapy
Patients undergo radiotherapy

Radiation: intensity-modulated radiation therapy
Patients undergo radiotherapy

Experimental: 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.
Biological: panitumumab
Given IV

Radiation: 3-dimensional conformal radiation therapy
Patients undergo radiotherapy

Radiation: accelerated radiation therapy
Patients undergo accelerated fractionation radiotherapy

Radiation: intensity-modulated radiation therapy
Patients undergo radiotherapy




Primary Outcome Measures :
  1. Progression-free Survival (PFS) Rate [ Time Frame: 6.2 years ]

    The progression event is defined by first event of the following,

    Local-regional progression or recurrence Distant metastasis Non-protocol RT, chemotherapy, or biologic therapy without documentation of the site of failure Surgery of primary site with tumour present/unknown Neck dissection with tumour present/unknown, > 15 weeks from end of RT Death due to study cancer or from unknown causes or any other reason

    Number of patients with and without progression event will be reported.



Secondary Outcome Measures :
  1. Overall Survival Rate [ Time Frame: 6.2 years ]

    Overall survival is defined as the time interval between the date of randomization to date of death from any cause (calculated in months). Otherwise, survival is censored at the last date that the patient is known to be alive.

    Number of death and alive patients will be reported.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820248


Locations
Show Show 19 study locations
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
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Principal Investigator: Lillian L. Siu, MD, FRCPC Princess Margaret Hospital, Canada
Study Chair: John Waldron, MD Princess Margaret Hospital, Canada
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00820248    
Other Study ID Numbers: HN6
CAN-NCIC-HN6 ( Registry Identifier: NCI US - Physician Data Query )
CDR0000630159 ( Other Identifier: PDQ )
First Posted: January 12, 2009    Key Record Dates
Results First Posted: June 20, 2017
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):
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
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Cisplatin
Panitumumab
Antineoplastic Agents
Antineoplastic Agents, Immunological