Know Cancer

forgot password

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

Phase 2
18 Years
75 Years
Open (Enrolling)
Oropharyngeal Cancer, Hypopharyngeal Cancer, Laryngeal Cancer

Thank you

Trial Information

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

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.

Inclusion Criteria

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 of the oral cavity, oropharynx, hypopharynx or

- Indication for chemoradiation (RT + Cisplatin)

- 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

- History of malignancy other than basal cell skin cancer unless disease free for a
minimum of 3 years.

- History of claudication, bleeding, or thromboembolic disorders.

- Patients receiving heparin, warfarin or phenprocoumon therapy are ineligible.

- Blood pressure of systolic >150 mmHg and or diastolic >100 mmHg

- 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

- 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 or cisplatin, or severe allergic reactions (= Grade 3) to
cetuximab loading dose

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Locoregional tumor control

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Oliver Riesterer, Oberarzt

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Zurich, Division of Radiation Oncology


Switzerland: Swissmedic

Study ID:

Add-On cetuximab



Start Date:

September 2011

Completion Date:

November 2015

Related Keywords:

  • Oropharyngeal Cancer
  • Hypopharyngeal Cancer
  • Laryngeal Cancer
  • Laryngeal Neoplasms
  • Head and Neck Neoplasms
  • Oropharyngeal Neoplasms
  • Hypopharyngeal Neoplasms