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Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Squamous Cell Carcinoma, Growth Factor, Surgery

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Trial Information

Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery


Inclusion Criteria:



- Age 18 years and over

_ histological proven squamous cell carcinoma of the oral cavity, oropharynx,
hypopharinx or larynx

- Patients selected for a primary surgical treatment

- no distant metastases

- no active second malignancy during the last 5 years except non melanoma skin cancer
or carcinoma in situ of the cervix

- no prior or concurrent evidence of uncontrolled severe pathology precluding
administration of surgery

- life expectancy of more than 3 months

- not pregnant or nursing; fertile patients both male and female, must use effective
contraception

- absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule;
those conditions should be discussed with the patient before registration in the
trial

- signed informed consent

- performance status ECOG 0-1

Exclusion Criteria:

- Nasopharynx cancer

- past or current malignancy other than HNSCC

- performance ECOG status more than 2

- concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not
indicated in the study protocol

- use of any investigational agents within 4 weeks prior to entry

- Previous exposure to EGFR targeting therapy

- known grade hypersensitivity to cetuximab

- legal incapacity or limited legal capacity or medical or psychological condition
which in the opiniion of the investigator would not permit the patient to complete
the study or sign meaningful informed consent.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

identification of the biomarkers could lead to the development of peri-operative targeted therapies to decrease the risk of local and distant tumor growth

Outcome Time Frame:

5 months

Safety Issue:

Yes

Principal Investigator

Jean-Pascal Machiels, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cliniques Universitaires St Luc-UCL

Authority:

Belgium: Ethics Committee

Study ID:

UCL-ONCO 2008-03

NCT ID:

NCT01280318

Start Date:

January 2009

Completion Date:

September 2012

Related Keywords:

  • Head and Neck Squamous Cell Carcinoma
  • Growth Factor
  • Surgery
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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