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NCT00820248 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2023-08-22

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-free Survival (PFS) Rate

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outcome · POSTED

Overall Survival Rate

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: cisplatin
    2. Radiation: 3-dimensional conformal radiation therapy
    3. Radiation: intensity-modulated radiation therapy
    label
    Arm I
    type
    ACTIVE_COMPARATOR
  2. description
    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.
    intervention Names
    1. Biological: panitumumab
    2. Radiation: 3-dimensional conformal radiation therapy
    3. Radiation: accelerated radiation therapy
    4. Radiation: intensity-modulated radiation therapy
    label
    Arm II
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm II
    description
    Given IV
    name
    panitumumab
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Arm I
    description
    Given IV
    name
    cisplatin
    type
    DRUG
  3. arm Group Labels
    1. Arm I
    2. Arm II
    description
    Patients undergo radiotherapy
    name
    3-dimensional conformal radiation therapy
    type
    RADIATION
  4. arm Group Labels
    1. Arm II
    description
    Patients undergo accelerated fractionation radiotherapy
    name
    accelerated radiation therapy
    type
    RADIATION
  5. arm Group Labels
    1. Arm I
    2. Arm II
    description
    Patients undergo radiotherapy
    name
    intensity-modulated radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
320
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Progression-free Survival (PFS) Rate
    time Frame
    6.2 years
secondary Outcomes
  1. description
    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.
    measure
    Overall Survival Rate
    time Frame
    6.2 years
Full study description
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.
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.
Source references
references
  1. citation
    Ringash J, Waldron JN, Siu LL, Martino R, Winquist E, Wright JR, Nabid A, Hay JH, Hammond A, Sultanem K, Hotte S, Leong C, El-Gayed AA, Naz F, Ramchandar K, Owen TE, Montenegro A, O'Sullivan B, Chen BE, Parulekar WR. Quality of life and swallowing with standard chemoradiotherapy versus accelerated radiotherapy and panitumumab in locoregionally advanced carcinoma of the head and neck: A phase III randomised trial from the Canadian Cancer Trials Group (HN.6). Eur J Cancer. 2017 Feb;72:192-199. doi: 10.1016/j.ejca.2016.11.008. Epub 2016 Dec 29.
    pmid
    28040660
    type
    BACKGROUND
  2. citation
    Siu LL, Waldron JN, Chen BE, Winquist E, Wright JR, Nabid A, Hay JH, Ringash J, Liu G, Johnson A, Shenouda G, Chasen M, Pearce A, Butler JB, Breen S, Chen EX, FitzGerald TJ, Childs TJ, Montenegro A, O'Sullivan B, Parulekar WR. Effect of Standard Radiotherapy With Cisplatin vs Accelerated Radiotherapy With Panitumumab in Locoregionally Advanced Squamous Cell Head and Neck Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2017 Feb 1;3(2):220-226. doi: 10.1001/jamaoncol.2016.4510.
    pmid
    27930762
    type
    RESULT
  3. citation
    Cuffe S, Hon H, Tobros K, Espin-Garcia O, Brhane Y, Harland L, Fadhel E, Eng L, LaDelfa A, Waldron J, Siu LL, Chen BE, Xu W, Simmons C, Kassam Z, Montenegro A, Parulekar WR, Liu G. Cancer patients' acceptability of incorporating an epidemiology questionnaire within a clinical trial. Clin Trials. 2015 Jun;12(3):237-45. doi: 10.1177/1740774514568689. Epub 2015 Jan 29.
    pmid
    25633805
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice