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AzTrials

Head and Neck CancerPhase 3NCT01142414

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

A Phase 3 study testing panitumumab, cisplatin and fluorouracil in people with Head and Neck Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
panitumumab, cisplatin and fluorouracil
Type of treatment
Surgery or procedure
How many people
0 participants
Where
No sites listed yet
Study dates
Start not givento not given
Phase
Phase 3
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

About this study

Official title: Randomized Phase III Trial on Postoperative Chemoradiation in Combination With Anti EGFR-Antibody Versus Postoperative Chemoradiation in Head and Neck Squamous Cell Carcinomas (HNSCC) With High Risk of Locoregional Recurrence

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. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. 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 chemotherapy given together with radiation therapy is more effective with or without panitumumab in treating patients with advanced cancer of the hypopharynx, oropharynx, larynx, or oral cavity.

PURPOSE: This randomized phase III trial is studying chemotherapy given together with radiation therapy to see how well it works compared with chemotherapy and radiation therapy given together with 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.

Read the 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-free survival of patients with macroscopically completely resected, advanced squamous cell carcinoma of the hypopharynx, oropharynx, larynx, or oral cavity at high risk of recurrence.

Secondary

  • To determine if the pre-surgery dose of panitumumab will alter the RNA expression of several genes and that these changes will provide additional prognostic information that can be used in future patient management. (Exploratory)
  • Measure the differences in RNA expression by RNA microarray and the results analyzed to create a gene expression classifier that will be checked for outcome prediction by association with disease free survival and down regulation of the glucose metabolism as measured by FDG-PET. (Exploratory)
  • To create a European biobank of biological samples which can be used for future research projects in this disease. (Exploratory)
  • To predict radiation-induced normal tissue toxicity based on in vitro lymphocyte apoptosis test and SNPs analysis. (Exploratory)
  • To assess the impact of radiation-induced side effects (swallowing dysfunction and xerostomia) on patient's quality of life.

OUTLINE: This is a multicenter study. Patients are stratified by treatment center, radiotherapy technique (3D-CRT vs IMRT), chemotherapy regimen (European Organization for Research and Treatment of Cancer [EORTC]) vs Arbeitsgemeinschaft Radiology Oncology [ARO] schedule), tumor location (larynx vs oropharynx vs hypopharynx vs oral cavity), pN-stage (pN0-2 vs pN3), pT-stage (pT1-2 vs pT3-4), margin/extracapsular extension (ECE) status (ECE+ and margin < 5 mm vs ECE- and margin < 5 mm vs ECE+ and margin > 5 mm), biological pre-study participation (yes vs no), p16 status (positive vs negative vs indeterminable). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (chemoradiotherapy): Within 4-8 weeks of surgery, patients undergo 3D-conformal or intensity-modulated radiotherapy once daily 5 days a week in weeks 1-7. Patients also receive concurrent chemotherapy comprising either cisplatin IV over 1-2 hours on days 1, 22, and 43 (EORTC schedule) OR cisplatin IV over 1-2 hours and fluorouracil IV over 24 hours on days 1-5 and 29-33 (ARO schedule), in the absence of disease progression or unacceptable toxicity.
  • Arm II (chemoradiotherapy plus panitumumab): Within 4-8 weeks of surgery, patients undergo 3D-conformal or intensity-modulated radiotherapy and receive concurrent chemotherapy (EORTC schedule or ARO schedule) as in arm I. Patients also receive panitumumab IV over 1 hour on days 1, 8, 15, 22, 29, 36, and 43.

Blood samples are collected periodically for biomarker correlative studies and translational research. Patients complete quality-of-life EORTC questionnaires QLQ-C30, QLQ-HN35, and PSS-HN periodically.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Being tested
panitumumab, cisplatin, fluorouracil, laboratory biomarker analysis, adjuvant therapy
Keywords
stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, tongue cancer
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Tongue Neoplasms

What participants receive

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

  • panitumumabBiological

  • cisplatinDrug

  • fluorouracilDrug

  • laboratory biomarker analysisOther

  • adjuvant therapyProcedure or surgery

  • quality-of-life assessmentProcedure or surgery

  • 3-dimensional conformal radiation therapyRadiation

  • intensity-modulated radiation therapyRadiation

What is being measured

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

  1. Disease-free survival

Secondary outcomes (6)

  1. Overall survival

  2. Loco-regional control

  3. Cumulative incidence of and time to distant metastases

  4. Cumulative incidence of and time to second cancers (all sites)

  5. Incidence of acute and late toxicity (CTCAE version 4.0)

  6. Health-related quality of life

Timeline

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

  1. First posted11 Jun 2010 (estimated)

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
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01142414
Sponsor's protocol ID
EORTC-22071-24071
Other IDs
EORTC-22071, EORTC-22071-24071, EU-21038, EUDRACT-2008-006180-36, AMGEN-EORTC-22071
Status last verified
Jan 2012
First submitted
10 Jun 2010
Last updated
16 Jan 2012
Results posted
No

Publications

  • Liberatoscioli C, Langendijk JA, Van Herpen C, et al.: EORTC 22071-24071: randomized, phase III trial of EGFR-antibody combined with adjuvant chemoradiation for patients with head and neck squamous cell carcinoma (HNSCC) at high risk of recurrence. [Abstract] J Clin Oncol 29 (Suppl 15): A-TPS197, 2011.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing panitumumab, cisplatin and fluorouracil in people with Head and Neck Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC.

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: withdrawn, as of the sponsor's last update on 16 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Disease-free survival. 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 NCT01142414, which also lists 1 linked publication.

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 16 Jan 2012.

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