Treatment of Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized multicenter open label phase III factorial trial evaluating the 3 years OS in patients with locally advanced squamous cell carcinoma of head and neck treated with locoregional treatment (radiotherapy plus concomitant chemotherapy or cetuximab) with or without neoadjuvant chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Associazione Volontari Pazienti Oncologici
• Collaborator: Mario Negri Institute for Pharmacological Research
• Treatments: Cetuximab; Cisplatin; Docetaxel; Fluorouracil

Criteria

Inclusion Criteria:

1. Histologically or cytologically proven squamous cell carcinoma of the head and neck.

2. Primary tumor sites eligible : oral cavity, oropharynx, hypopharynx Although they are admittedly of squamous cell types, the following tumors will be excluded because of them responsiveness to chemotherapy: tumors of the nasal and paranasal cavities and of the nasopharynx.

3. Stage 3 or 4 disease without evidence of distant metastases verified by chest X Ray, abdominal ultrasound, or CT (liver function test abnormalities); bone scan in case of local symptoms.

4. At least one uni or bidimensionally measurable lesion.

5. Tumor considered inoperable after evaluation by a multidisciplinary team (i.e. a surgeon, a medical oncologist and a radiation oncologist). Criteria for inoperability are:

1. technical unresectability: tumor fixation/invasion to base of the skull or cervical vertebrae, involvement of the nasopharynx, and fixed lymph nodes.

2. Physician decision based on low surgical curability. This category will include the following:

i) All T3-4 stages. ii) All N2-3 stages excluding T1 N2. iii) Patients for organ preservation. Reason for inoperability will be recorded in the CRF.

6. No previous chemotherapy or radiotherapy for any reason and no previous surgery for SCCHN (other than biopsy) are allowed at time of study entry.

7. Age > 18 years.

8. Karnofsky performance status > 70. (ECOG 0-1) (Appendix II)

9. No active alcohol addiction.

10. Life expectancy > 6 months.

11. Signed informed consent prior to beginning protocol specific procedures.

12. Adequate bone marrow, hepatic and renal functions as evidenced by the following:

a) Hematology (Bone marrow): i) Neutrophils > 2.0 109/L ii) Platelets > 100 x 109/L iii) Hemoglobin > 10 g/dL b) Hepatic function i) Total bilirubin < 1 x UNL ii) ASAT (SGOT) and ALAT (SGPT) < 2.5 x ULN iii) Alkaline phosphatase < 5 x ULN Patients with ASAT or ALAT > 1.5 x ULN associated with alkaline phosphatase > 2.5 x ULN are not eligible for the study.

c) Renal function : serum creatinine < 1 x UNL. In case of borderline value the creatinine clearance > 60 ml/min (calculated by the Cockcroft-Gault method as follows :

13. Patients must be available for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating center.

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Exclusion Criteria:

1. Pregnant or lactating women or women of childbearing potential not using adequate contraception.

2. Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin, or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years. Any prior treatment with radiotherapy or chemotherapy is an exclusion criterion.

3. Symptomatic peripheral neuropathy > grade 2 by NCIC-CTG criteria

4. Symptomatic altered hearing > grade 2 by NCIC-CTG criteria.

5. Other serious illnesses or medical conditions including:

1. Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry.

2. History of significant neurologic or psychiatric disorders including dementia or seizures.

3. Active uncontrolled infection.

4. Active peptic ulcer.

5. Hypercalcemia.

6. Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry

6. History of hypersensitivity reaction to polysorbate 80 (Appendix IV)

7. Patients requiring intravenous alimentation.

8. Patients who experienced a weight loss of more than 20% of their body weight in the 3 months preceding study entry.

9. Concomitant treatment with any other anticancer therapy.

10. Participation in a therapeutic clinical trial within 30 days of study entry