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Induction Chemotherapy Followed by Chemoradiation With Cetuximab and Cisplatin for Inoperable Squamous Cell Carcinoma of the Head and Neck

Phase 2
18 Years
Not Enrolling
Head and Neck Cancer

Thank you

Trial Information

Induction Chemotherapy Followed by Chemoradiation With Cetuximab and Cisplatin for Inoperable Squamous Cell Carcinoma of the Head and Neck

The treatment results with radiotherapy in inoperable squamous cell carcinoma of the head
and neck are poor.

In this proposed single-institution non-randomized, one-arm, open label phase II study, the
authors will test the efficacy and toxicity of docetaxel/cisplatin/5-fluorouracil induction
chemotherapy (4 cycles) followed by concomitant chemoradiation with cetuximab and weekly
cisplatin in patients with inoperable squamous cell carcinoma of the head and neck.

Chemotherapy doses will be as follows: docetaxel 75 mg/m2 I.V. day 1, cisplatin 75 mg/m2
I.V. day 1, 5-fluorouracil 750 mg/m2 I.V. continuous infusion days 1-5 repeated every 21
days for 4 cycles followed by cetuximab 400 mg/m2 I.V. week 13, cetuximab 250 mg/m2 I.V.
weeks 14-20, cisplatin 30 mg/m2 I.V. weeks 14-20. Three-dimensional conformal radiotherapy
planning and delivery (35x2 Gy/day over 7 weeks {weeks 14 - 20}) will be used.

The planned number of patients to be included is 30 and anticipated enrolment period is 12

The primary objective of the study is to determine locoregional control at 2 years
post-therapy, whereas secondary objectives are to determine feasibility (toxicity profile)
of the proposed regimen, to determine complete response rate after induction ChT as well as
14-16 weeks after the therapy, completion of ChRT to determine disease free survival at 2
years, overall survival at 2 years and late toxicity including thyroid function.

Given the preliminary nature of the study, no stopping rule is prospectively planned outside
of observed toxicity, which will be assessed and graded according to Common Terminology
Criteria for Adverse Events version 3.0.

Inclusion Criteria:

- Squamous cell carcinoma, histologically proven

- Tumour site: oral cavity, oropharynx, hypopharynx or larynx.

- Locally and/or regionally inoperable tumors (UICC TNM stages IVa or IVb) - -
without distant metastases (M0-stage)

- Male or female ≥18 years of age

- Expected survival >6 months

- Presence of at least one bidimensionally measurable index lesion

- Effective contraception for both male and female subjects if risk of conception

- WHO performance status 0-2

- Laboratory parameters:

hemoglobin ≥100 g/L leukocyte count > 3.5x109/L, absolute neutrophil count ≥ 1.5x109/L
platelet count > 100x109/L total bilirubin < 1.25x upper normal limit transaminases (ALT,
AST) < 5x upper normal limit creatinine clearance ≥ 55 mls/minute

- Signed written informed consent

Exclusion Criteria:

- Metastatic disease

- Squamous cell carcinoma of the nasopharynx and nasal cavity and paranasal sinuses

- ChT or XRT ineligibility:

Unstable cardiac disease or any other medical condition likely to compromise the safe
delivery of ChT or XRT; Clinically evident hearing impairment; Pre-existing motor or
sensory neurotoxicity grade ≥ 2 according to the CTCAE v3.0;

- Any kind of previous therapy for SCCHN (excluding diagnostic biopsy)

- Previous administration of EGFR pathway-targeting therapy

- Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy which is
not part of the study protocol

- Participation in another clinical trial within 30 days prior to study entry

- Pregnancy or breast feeding

- History of severe acute pulmonary disease

- Any investigational agent within past 30 days

- Other previous malignancy within 5 years, with exception of a history of a previously
adequately treated basal cell carcinoma of the skin or pre- invasive carcinoma of the

- Known drug abuse / severe alcohol abuse

- Legal incapacity or limited legal capacity

- Medical or psychological condition which in the opinion of the investigator would not
permit the subject to complete the study or sign meaningful informed consent

- Active, uncontrolled infection

- Other medical condition or other therapy that in the opinion of the investigator
precludes the safe administration of the planned ChT and XRT

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

locoregional control

Outcome Time Frame:

at 2 years post-therapy

Safety Issue:


Principal Investigator

Primož Strojan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. of Radiation Oncology, Institute of Oncology Ljubljana, Slovenia


Slovenia: Ethics Committee

Study ID:




Start Date:

March 2008

Completion Date:

October 2011

Related Keywords:

  • Head and Neck Cancer
  • head and neck cancer
  • inoperable
  • induction chemotherapy
  • concomitant radiochemotherapy
  • biological agent
  • efficacy
  • toxicity
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms