A Phase 3, Randomized, Open-label Clinical Trial of Induction Chemotherapy Followed by Chemoradiotherapy Versus Chemoradiotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

Barretos Cancer Hospital1 site in 1 country434 target enrollmentDecember 19, 2018

ConditionsLocally Advanced Malignant Neoplasm

InterventionsInduction chemotherapy Chemoradiotherapy

DrugsInduction chemotherapy

Overview

Phase: Phase 3
Intervention: Induction chemotherapy
Conditions: Locally Advanced Malignant Neoplasm
Sponsor: Barretos Cancer Hospital
Enrollment: 434
Locations: 1
Primary Endpoint: 3-years overall survival
Status: Recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The benefit of induction chemotherapy followed by chemoradiotherapy for locally advanced head and neck squamous cell carcinoma is unknown. The present study is investigating if this therapeutic strategy improve overall survival.

Registry

clinicaltrials.gov

Start Date

December 19, 2018

End Date

December 2025

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Barretos Cancer Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Confirmed histological diagnosis of squamous cell carcinoma or undifferentiated carcinoma of the oropharynx, hypopharynx or larynx;
•Locally advanced stage (stage IVa / b - AJCC 8th edition), classified as resectable \*\* or unresectable and candidate for treatment based on radiotherapy and chemotherapy;
•Locally advanced stage (stage III - AJCC 8th edition), classified as resectable or unresectable, positive p16 and candidate for treatment based on radiotherapy and chemotherapy;
•It will be allowed to include a patient with cervical lymphadenectomy if the primary lesion is measurable;
•Presence of measurable disease according to RECIST 1.1 criteria;
•ECOG performance status of 0-1;
•≥ 18 years;
•Adequate marrow reserve indicated by:
•Absolute neutrophil count (ANC) ≥ 1500 / mm³ or Platelets\> 100,000 / mm³
•Hemoglobin ≥ 9 g / dL - red blood cell transfusion will be allowed in the screening period if necessary

Exclusion Criteria

•Patient submitted to curative resection of the primary site and / or metastatic site. NOTE: Patients submitted to cervical lymphadenectomy without surgery to the primary tumor are eligible;
•Radiation therapy or previous chemotherapy for head / neck tumor;
•Patients with occult primary tumor;
•T4 from any site, resectable, with invasion of cartilage or jaw;
•History of BMT or stem cell therapy;
•Synchronous tumor or previous history of neoplasia, except for in situ carcinoma of the cervix, basal cell carcinoma or epidermoid carcinoma. Patients with previous history of cancer already treated and without evidence of disease for more than 3 years may participate in the study;
•Prophylactic use of G-CSF or GM-CSF two weeks prior to the study;
•Clinically significant heart disease: unstable angina or myocardial infarction 6 months prior to study entry Symptomatic ventricular arrhythmia the ICC classified as NYHA ≥ II • Uncontrolled hypercalcemia;
•Uncontrolled infection;
•Any other comorbidity that the investigator's judgment is inappropriate for the study;

Arms & Interventions

A - induction chemotherapy

Intervention: Induction chemotherapy

A - induction chemotherapy

Intervention: Chemoradiotherapy

B - chemoradiotherapy

Intervention: Chemoradiotherapy

Outcomes

Primary Outcomes

3-years overall survival

Time Frame: From date of randomization until 3 years

Secondary Outcomes

Adverse Events Rates(At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 21 days).)
Progression free survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
Systemic relapse free survival(From date of randomization until the date of first systemic relapse or date of death from any cause, whichever came first, assessed up to 100 months)
Overall survival(From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months)
Overall response rate(At the end of Cycle 3 of IC (each cycle is 21 days) and 8 weeks after the end of radiotherapy, through study completion, an average of 6 months)
1-year functional organ preservation rate(From date of randomization until 1 year after)
Quality of Life (EORTC Quality of Life Questionnare - C30 version 3.0)(From date of randomization until 5 years)
Overall response rate to induction chemotherapy(At the end of Cycle 3 (each cycle is 21 days))