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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase: Completed; Phase 2; Phase 1

Conditions: Surgery; Head and Neck Squamous Cell Carcinoma; Growth Factor

Treatments: Procedure: head and neck surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01280318

UCL-ONCO 2008-03

Academic study

Details and patient eligibility

About

The obvious hypothesis is that the application of peri-operative targeted biological agents may counteract the tumor growth effect of these circulating factors and improve patient outcome

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

1

Other group

Description:

patients with operable head and neck squamous cell carcinoma

Treatment:

Procedure: head and neck surgery

2

Other group

Description:

patients treated by neck ansd head surgery for a non-oncological disease

Treatment:

Procedure: head and neck surgery

3

Experimental group

Description:

patients treated before surgery with 3 doses of neoadjuvant cetuximab

Treatment:

Procedure: head and neck surgery