A Phase II Study In Patients With Advanced Head And Neck Cancer Of Standard Chemoradiation And Add-On Cetuximab

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. Identifier: NCT01435252
Recruitment Status : Completed
First Posted : September 16, 2011
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
Oliver Riesterer, University of Zurich

July 26, 2011
September 16, 2011
November 6, 2017
September 19, 2011
October 25, 2017   (Final data collection date for primary outcome measure)
Locoregional tumor control [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT01435252 on Archive Site
  • Progression free survival (PFS) [ Time Frame: 2 years ]
  • Overall survival (OS) [ Time Frame: 2 years ]
  • Metastasis rate [ Time Frame: 2 years ]
  • Metastasis free survival (MFS) [ Time Frame: 2 years ]
  • Biological surrogate markers [ Time Frame: 2 years ]
  • Safety and tolerability [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
A Phase II Study In Patients With Advanced Head And Neck Cancer Of Standard Chemoradiation And Add-On Cetuximab
A Phase II, Randomized, Open-Label, Single Center Study In Patients With Advanced Head And Neck Cancer To Investigate Efficacy And Safety Of Standard Chemoradiation And Add-On Concurrent Cetuximab ± Consolidation Cetuximab

Sixty patients with advanced squamous cell carcinomas of the head and neck will be enrolled in this study. Patients are treated with standard chemoradiation in combination with concurrent add-on cetuximab. Subsequently patients are randomized to cetuximab consolidation therapy (three months, Arm A) versus no consolidation therapy (Arm B). The aim of this study is to investigate if cetuximab consolidation therapy improves the 2-year locoregional control rate.

  • Trial with medicinal product
  • Trial with radiotherapy

This clinical study translates our preclinical findings that concurrent and consolidation cetuximab improves efficacy of RT into the clinic. It is a phase II, randomized, open-label, single center study in patients with locoregionally advanced stage III-IV and/or total gross tumor volume (tGTV) > 70cc head and neck cancer. This study population is at high risk for locoregional recurrence after chemoradiation alone. Tumor stages to be included are T3-4 Nx, Tx N2b-N3 (N2b only if ≥ 3 ipsilateral nodes involved) M0 and/or tGTV >70 cc (any T, any N, M0) squamous cell cancers of the head and neck (HNSCC). All patients will receive in, the so called 'Induction Phase' standard chemoradiation (RT up to 70 Gy in combination with weekly CDDP 40 mg/m2) and add-on concurrent cetuximab (loading Dose 400 mg/m2, concurrent dose 250 mg/m2 weekly). The patients are randomized to either add-on consolidation cetuximab (500 mg/m2 biweekly x 6 over 12 weeks) (Arm A) or no further treatment (Arm B). Randomization will take place after Induction Phase. The total number of patients to be included into the study is 60 (30 patients per arm). Up to 6 patients may be replaced in case of early drop out to reach that aim.

The sample size of 60 patients is considered to be sufficient to collect first information on clinical efficacy and the possible impact of various biomarkers on clinical endpoints. If the results of this study will demonstrate that the novel treatment regimen is safe and efficacious, a randomized multicenter phase III study will follow.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Oropharyngeal Cancer
  • Hypopharyngeal Cancer
  • Laryngeal Cancer
Drug: Cetuximab
Arm A: chemoradiation in combination with concurrent cetuximab Arm B: chemoradiation in combination with concurrent and consolidation cetuximab
Other Name: Erbitux®
  • Experimental: Arm A
    Patients will be treated with chemoradiation in combination with concurrent cetuximab. Two weeks after end of chemoradiation the consolidation phase will start and patients will receive biweekly consolidation cetuximab, maximally 6 infusions over 12 weeks.
    Intervention: Drug: Cetuximab
  • Experimental: Arm B
    Patients will be treated with chemoradiation in combination with concurrent cetuximab.
    Intervention: Drug: Cetuximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 25, 2017
October 25, 2017   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • T3-4 Nx M0; Tx N2b-3 M0 (N2b only if ≥ 3 ipsilateral nodes involved) and/or total GTV > 70 cc (any T, any N, M0)
  • biopsy proven squamous cell cancer
  • primary tumor location in oral cavity, oropharynx, hypopharynx or larynx
  • Patients with CUP (cancer of unknown primary) syndrome in case they have advanced lymph node metastases (Tx N2b-3 M0 (N2b only if ≥ 3 ipsilateral nodes involved).- Indication for chemoradiation (RT + Cisplatin)
  • curative treatment intent
  • Start of chemoradiation within the recruitment time frame
  • Performance Status WHO/ECOG: 0-1
  • Age between 18 and 75 years
  • No previous chemotherapy or RT for cancer of the head and neck
  • Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study (until at least 60 days following the last study treatment
  • Patient must sign informed consent prior to study entry.

Exclusion criteria:

  • Cancer of the nasopharynx
  • Any neoadjuvant chemotherapy prior to screening
  • Treatment with other investigational drugs within 4 weeks
  • History of malignancy other than basal cell skin cancer unless disease free for a minimum of 3 years.
  • Uncontrolled claudication, bleeding, or thromboembolic disorders at screening
  • Patients receiving heparin, warfarin or phenprocoumon therapy are ineligible- Uncontrolled and severe hypertension at screening according to the judgement of the investigator.
  • Current uncontrolled cardiac disease: Unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, history of myocardial infarction within 12 months, significant arrhythmias
  • Left ventricular function < 45 % (determination of left ventricular function required when history of cardiac disease)
  • History of stroke within 6 months
  • Major surgical procedure, or significant traumatic injury within 28 days prior to screening; anticipation of need for major surgical procedure during the course of the study.
  • Acute bacterial or fungal infection requiring intravenous antibiotics at screening
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at screening
  • Pregnant (positive pregnancy test) or lactating
  • Previous organ transplantation
  • Any immune suppressive therapy
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition because study treatment might be immuno-suppressive (Note: HIV testing only required if clinically indicated)
  • Any uncontrolled condition, which in the opinion of the investigator, would interfere with the safe and timely completion of study procedures.
  • Preexisting renal insufficiency with impaired creatinine clearance (<60ml/min) and/or increased plasma creatinine (>106 µmol/l) at screening
  • History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 6 months prior to screening
  • Serious, non-healing wound, ulcer, or bone fracture
  • AST, ALT, or bilirubin > 1.5 x normal
  • Preexisting absolute neutrophil count (ANC) < 1,800 cells/mm3
  • Platelets < 100,000 103/µl at screening
  • PTT > 1.5 x normal
  • WBC < 4000 103/µl
  • Hb < 11 g/dl at screening (Note: The use of transfusion or other intervention to achieve Hb > 11 g/dl is possible)
  • Contraindication to CDDP
  • Known allergy to cetuximab
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Add-On cetuximab
Not Provided
Not Provided
Oliver Riesterer, University of Zurich
University of Zurich
Not Provided
Principal Investigator: Oliver Riesterer, Leitender Arzt University Hospital Zurich, Division of Radiation Oncology
University of Zurich
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP