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

NCT ID: NCT01280318

Last Updated: 2012-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-09-30

Brief Summary

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

Conditions

Head and Neck Squamous Cell Carcinoma; Growth Factor; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

patients with operable head and neck squamous cell carcinoma

Group Type: OTHER

head and neck surgery

Intervention Type: PROCEDURE

Blood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery.

2

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

Group Type: OTHER

head and neck surgery

Intervention Type: PROCEDURE

Blood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery.

3

patients treated before surgery with 3 doses of neoadjuvant cetuximab

Group Type: EXPERIMENTAL

head and neck surgery

Intervention Type: PROCEDURE

Blood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery.

Interventions

head and neck surgery

Blood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Pascal Machiels, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques Universitaires St Luc-UCL

Locations

Jean-Pascal Machiels

Brussels, , Belgium

Countries

Belgium

Other Identifiers

Academic study

Identifier Type: -

Identifier Source: secondary_id

UCL-ONCO 2008-03

Identifier Type: -

Identifier Source: org_study_id