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

NCT01280318 | Completed Phase 1

• 2 other identifiers: UCL-ONCO 2008-03Academic study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  5 months

Secondary Outcomes (1)

• Compare the results of group I with groups II and III

  5 months

Study Arms (3)

1

OTHER

patients with operable head and neck squamous cell carcinoma

Procedure: head and neck surgery

2

OTHER

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

Procedure: head and neck surgery

3

EXPERIMENTAL

patients treated before surgery with 3 doses of neoadjuvant cetuximab

Procedure: head and neck surgery

Interventions

head and neck surgery PROCEDURE

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

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Jean-Pascal Machiels

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Jean-Pascal Machiels, PhD

  Cliniques Universitaires St Luc-UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: January 20, 2011
• Study Start: January 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: September 1, 2012
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

BE (1)