Induction Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma (INDUCTION)

July 16, 2019 updated by: Barretos Cancer Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

434

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Recruiting
        • Barretos Cancer Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Augusto E Mamere, MD, MSc
        • Sub-Investigator:
          • Alexandre A Jacinto, MD
        • Sub-Investigator:
          • Domingos Boldrini Junior, MD, MSc
        • Sub-Investigator:
          • Renato C Capuzzo, MD
        • Sub-Investigator:
          • Carlos R Santos, MD
        • Sub-Investigator:
          • Andre L Carvalho, MD, PhD
        • Sub-Investigator:
          • Luciano S Vianna, MD, PhD
        • Sub-Investigator:
          • Josiane D Mourão, MD
        • Sub-Investigator:
          • Ricardo R Gama, MD, PhD
        • Sub-Investigator:
          • Gustavo J Dix, MD, MSc
        • Sub-Investigator:
          • Diogo D Prado, MD
        • Principal Investigator:
          • Pedro De Marchi, MD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

  • Adequate renal and hepatic function:

    • Serum bilirubin ≤ 1.5 times the upper limit of normal the TGO and TGP ≤ 3 upper limit of normal. If hepatic metastasis ≤ 5 upper limit of normal
    • Serum creatinine ≤ 1.5 mg / dL and creatinine clearance ≥ 60 mL / min calculated by Cockcroft-Gault.

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;
  • Peripheral neuropathy> grade 2;
  • Hearing loss> grade 2;
  • Known positive serology for hepatitis B, hepatitis C or HIV
  • Use of antiretrovirals;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A - induction chemotherapy
Drug: Induction chemotherapy
3 cycles, each 21 days, of Cisplatin 80mg/m2 plus Paclitaxel 175mg/m2
Combination product: Chemoradiotherapy
Radiotherapy 70Gy convencional fractionation concomitant to 3 cycles, each 21 days, of Cisplatin 100mg/m2
EXPERIMENTAL: B - chemoradiotherapy
Combination product: Chemoradiotherapy
Radiotherapy 70Gy convencional fractionation concomitant to 3 cycles, each 21 days, of Cisplatin 100mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3-years overall survival
Time Frame: From date of randomization until 3 years
From date of randomization until 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 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
PFS
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
Time Frame: 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
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
Time Frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Overall response rate
Time Frame: 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
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
Adverse Events Rates
Time Frame: At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 21 days).
At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 21 days).
1-year functional organ preservation rate
Time Frame: From date of randomization until 1 year after
From date of randomization until 1 year after
Quality of Life (EORTC Quality of Life Questionnare - C30 version 3.0)
Time Frame: From date of randomization until 5 years
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
From date of randomization until 5 years
Overall response rate to induction chemotherapy
Time Frame: At the end of Cycle 3 (each cycle is 21 days)
At the end of Cycle 3 (each cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barretos Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 19, 2018

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

December 19, 2018

First Submitted That Met QC Criteria

January 23, 2019

First Posted (ACTUAL)

January 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BarretoCH - 201801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Locally Advanced Malignant Neoplasm

Clinical Trials on Induction chemotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe