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Clinical Trials/EUCTR2006-002187-25-SE
EUCTR2006-002187-25-SE
Active, not recruiting
Not Applicable

A multicenter, open label, non-randomised phase II study with induction chemotherapy with Cisplatin and 5-fluorouracil as combined with accelerated radiotherapy and Erbitux for locally advanced unresectable squamous cell carcinoma

Radiumhemmet, Karolinska University Hospital0 sites90 target enrollmentDecember 21, 2006
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ConditionsPatient with locally advanced non-resectable squamous cell carcinoma of the head and neck stage III or IV, oral, oropharyngeal, laryngeal or hypopharyngeal cancer, non-resectable.
DrugsErbitux

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patient with locally advanced non-resectable squamous cell carcinoma of the head and neck stage III or IV, oral, oropharyngeal, laryngeal or hypopharyngeal cancer, non-resectable.
Sponsor
Radiumhemmet, Karolinska University Hospital
Enrollment
90
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 21, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Radiumhemmet, Karolinska University Hospital

Eligibility Criteria

Inclusion Criteria

  • •Histologically confirmed squamous cell carcinoma of the head and neck \- stage III or IV, oral, oropharyngeal, laryngeal or hypopharyngeal cancer, non\-resectable.
  • •Patients must have evaluable and/or measureable disease
  • •Age \=18 years
  • •Performance status (WHO) of 0\-1\.
  • •Patient must have a life expectancy of at least 3 months allowing adequate follow\-up of toxicity evaluation.
  • •Previously untreated with chemo\-, immuno\- or radiotherapy
  • •Adequate hematological function defined as WBC \=3 x 109/litre and platelets \=100 x 109litre, ANC ³1\.5 x 109litre and HB \> 100 g/L
  • •Adequate renal function defined as creatinine clearence \= 50 ml/min
  • •Written informed consent must be obtained according to the local Ethics Committee requirements.
  • •Are the trial subjects under 18? no

Exclusion Criteria

  • •Patient with distant metastatic disease
  • •Oral stage I\-II, oropharyngeal ca T1\-T2 or N0\-N1, nasopharyngeal, lipcancer, glottic ca stage I\-II and cancer of the paranasal sinuses.
  • •Previous or some other concomitant malignancy, less than 5 years, with the exception of adequately treated basal cell skin cancer or in situ cervical cancer
  • •Inability to follow the treatment and evaluation schedule
  • •Any other condition or therapy which in the investigator’s opinion may pose a risk to the patient of interfere with the study objectives
  • •Pregnant or nursing females or patients of child\-bearing potential not using adequate methods of birth\-control
  • •Patients with active infections or other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment
  • •Known hypersensitivity to any of the components of the treatment
  • •Pre\-existing history of severe lung disease
  • •Legal incapacity.

Outcomes

Primary Outcomes

Not specified

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