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Head and Neck CancerPhase 3NCT00820248

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

A Phase 3 study testing panitumumab, cisplatin and 3-dimensional conformal radiation therapy in people with Head and Neck Cancer, run by NCIC Clinical Trials Group at 19 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
panitumumab, cisplatin and 3-dimensional conformal radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
19 sitesCanada
Study dates
30 Dec 2008to 17 Feb 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Canada19 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Northeast Cancer Center Health Sciences

    Greater Sudbury, Ontario, P3E 5J1

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Cancer Centre of Southeastern Ontario at Kingston

    Kingston, Ontario, K7L 5P9

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • McGill University - Dept. Oncology

    Montreal, Quebec, H2W 1S6

  • Ottawa Health Research Institute - General Division

    Ottawa, Ontario, K1H 8L6

  • CHUQ-Pavillon Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Atlantic Health Sciences Corporation

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Dr. H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, AIB 3V6

  • BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Thunder Bay Regional Health Science Centre

    Thunder Bay, Ontario, P7B 6V4

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
panitumumab, cisplatin, 3-dimensional conformal radiation therapy, accelerated radiation therapy, intensity-modulated radiation therapy
Keywords
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
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • panitumumabBiological

    Given IV

  • cisplatinDrug

    Given IV

  • 3-dimensional conformal radiation therapyRadiation

    Patients undergo radiotherapy

  • accelerated radiation therapyRadiation

    Patients undergo accelerated fractionation radiotherapy

  • intensity-modulated radiation therapyRadiation

    Patients undergo radiotherapy

Study groups in NCT00820248
Study groupRoleWhat they receive
Arm IActive comparatorPatients 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.
Receives: Drug: cisplatin; Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy
Arm IIExperimentalPatients 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.
Receives: Biological: panitumumab; Radiation: 3-dimensional conformal radiation therapy; Radiation: accelerated radiation therapy; Radiation: intensity-modulated radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) Rate

    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.

    Measured: 6.2 years

Secondary outcomes (1)

  1. Overall Survival Rate

    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.

    Measured: 6.2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2009 (estimated)
  2. Study start30 Dec 2008
  3. Primary completion16 May 2015
  4. Study completion17 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00820248
Sponsor's protocol ID
HN6
Other IDs
CAN-NCIC-HN6, CDR0000630159
Status last verified
Apr 2020
First submitted
9 Jan 2009
Last updated
22 Aug 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28040660

  • 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.

    PubMed 27930762

  • 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.

    PubMed 25633805

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing panitumumab, cisplatin and 3-dimensional conformal radiation therapy in people with Head and Neck Cancer, run by NCIC Clinical Trials Group at 19 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) Rate (time frame: 6.2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00820248, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.

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