None listed
Conditions
Interventions
Amifostine Type of group
Amifostine 500 mg SC prior to each radiotherapy session + Radiation Therapy (1.8-2.0 Gy), 5 days / week for 6-7 weeks
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients having definitive or adjuvant radiation therapy for histologically confirmed squamous cell carcinoma of the head and neck region. • Patients who enter the protocol followed by surgery with a curative attempt may enter as soon as the wound heals but not more than 12 weeks post-operatively. • Patients must have at least 75% of each parotid gland in the treatment fields. •> 18 years old • Life expectancy> 12 months. • Kamofsky scale> 70. • No evidence of distant metastatic disease. • Granulocyte count (segs & bands)> 2000 / mm3 and platelet count> 100,000 / mm3. • Serum creatinine <2.0 mg / dL. • Total Bilirubin <2.0 mg%, SGOT <3 times the upper limit to normal • Patients can not be in other therapeutic trials. • Patients should be informed and should know that this is a clinical research study and sign the informed consent prior to the study procedures.
Exclusion criteria
Exclusion criteria: • Primary lesion of the parotid gland. • Kamofsky scale <70. • Patients who are going to receive hyperfractionated or accelerated radiotherapy. • History of malignancy within the previous five years, except for non-melanoma cancer that has been controlled or carcinoma in situ of the cervix. • Patients previously treated with any chemotherapy for this malignancy or concurrent use of chemotherapy while participating in this study. • Patients may have received previous radiation therapy, but not for head and neck cancer. • The use of prophylactic pilocarpine is prohibited in this study. • Patients who have been treated with any investigational drug <4 weeks prior to admission to this study. • General medical or psychological conditions that would not allow the patient to complete the study or sign the informed consent. • Pregnancy. Sexually active women with the possibility of getting pregnant should practice effective contraceptive measures (intrauterine device, diaphragm + spermicide, condom + spermicide, oral contraceptives, progesterone implants (Norplant), medroxyprogesterone acetate (Depo-proveral), surgical sterilization or monogamous relationships with a partner with vasectomy, during the entire period of treatment and 6 months after stopping it.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Salivary gland function will be evaluated by: RTOG Acute and Late Radiation Scoring Criteria and Patient Questionnaire Measure:Evaluation of the Effect of Radiation Timepoints:After treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The overall effects of oral discomfort and dryness will be assessed based on the total score of the patients questionnaire. Measure:Acute and late toxicity Timepoints:During treatment | — |
Contacts
Public ContactOscar Barrenechea
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed