Scamous Cell- Carcinoma of Head and Neck Neoplasms Positron Emission Tomography Computed Tomography
Conditions
Interventions
Study of a single experimental arm, without control group (uncontrolled study), 49 recruited patients undergoing induction chemotherapy for Squamous- Cell Carcinoma of Head and Neck, in which experime
Procedure/surgery
Other
Sponsors
AC Camargo Cancer Center
AC Camargo Cancer Center
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Patients diagnosed with locally advanced squamous cell carcinoma of the head and neck; Clinical Stages III, IVa and IVb; Patients with primary tumors of oral cavity, oropharynx, larynx and hypopharynx; Patients candidates for curative therapy with induction chemotherapy with the use of 03 drugs (taxanes, platinum and fluoropyrimidine) followed by radiotherapy associated with chemotherapy;
Exclusion criteria
Exclusion criteria: Heart disease active or not compensated by treatment, or acute myocardial infarction in the previous 6 months. Active infection present (at the discretion of the investigator); Concomitant systemic diseases considered serious by the investigator; Another primary neoplasm (except in situ carcinoma of the uterine cervix or adequately treated basal cell carcinoma of the skin); Presence of severe psychiatric illness; Participation in another experimental drug protocol;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| primary outcome -To determine the efficacy of the treatment by correlating the variation of the maximum SUV in the primary tumor and in the cervical lymph nodes registered before the treatment and after the cycle 1 (fourteenth day) with the end points tumor recurrence or death (whichever occurs first) . The Kaplan-Meier method was used to estimate survival data and long-rank tests were used to compare disease-free and overall survival between the different groups observed (according to decrease or increase of SUV after treatment at the fourteenth day). Calculations of time-free of tumor recurrence or death were considered from the first day of the first cycle of induction chemotherapy and the occurrence of tumor recurrence or death, respectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| secondary outcome- determine the overall survival of patients according to the maximum SUV variation in the primary tumor and cervical lymph nodes with the outcome of death (related cancer or non-cancer related) | — |
Countries
Brazil
Contacts
Public ContactUlisses Nicolau
AC Camargo Cancer Center
Outcome results
None listed