se of the PET-Scan examination in the evaluation of the treatment of patients diagnosed with Head and Neck Cancer

Not Applicable

• Conditions: Scamous Cell- Carcinoma of Head and NeckNeoplasmsPositron Emission Tomography Computed Tomography; C04.557.470.200.400; E01.370.350.350.800.700.500

• Registration Number: RBR-9wwstd
• Lead Sponsor: AC Camargo Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-24
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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;

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>

Secondary Outcome Measures

Name	Time	Method
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)