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UNKNOWNPHASE3

Induction Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

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

NCT03815903•Barretos Cancer Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

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;
+4 more criteria

Locations (1)

Barretos Cancer Hospital

Barretos, São Paulo, Brazil

Key Dates

Start Date

December 19, 2018

Primary Completion Date

December 1, 2020

Completion Date

December 1, 2025

Last Updated

July 18, 2019

Enrollment

434

ESTIMATED participants

Conditions

Locally Advanced Malignant Neoplasm

Interventions

Induction chemotherapy

DRUG

Chemoradiotherapy

COMBINATION_PRODUCT

Cobimetinib and Atezolizumab in Treating Participants With Advanced or Refractory Rare Tumors

NCT03108131

Skin Squamous Cell CarcinomaAppendix Adenocarcinoma+10 more

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COMPLETEDPHASE1

A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid Tumors

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Solid TumorMetastatic Tumor+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Induction Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

Cobimetinib and Atezolizumab in Treating Participants With Advanced or Refractory Rare Tumors

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