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

Primary Purpose

Locally Advanced Malignant Neoplasm

Status

Recruiting

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Induction chemotherapy

Chemoradiotherapy

About this trial

This is an interventional treatment trial for Locally Advanced Malignant Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
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;

Sites / Locations

Barretos Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A - induction chemotherapy

B - chemoradiotherapy

Arm Description

Outcomes

Primary Outcome Measures

3-years overall survival

Secondary Outcome Measures

Progression free survival

PFS

Systemic relapse free survival

Overall survival

Overall response rate

Adverse Events Rates

1-year functional organ preservation rate

Quality of Life (EORTC Quality of Life Questionnare - C30 version 3.0)

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.

Overall response rate to induction chemotherapy

Full Information

NCT ID

NCT03815903

First Posted

December 19, 2018

Last Updated

July 16, 2019

Sponsor

Barretos Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03815903

Brief Title

Induction Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

Acronym

INDUCTION

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Recruiting

Study Start Date

December 19, 2018 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Barretos Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Malignant Neoplasm

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

434 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A - induction chemotherapy

Arm Type

Active Comparator

Arm Title

B - chemoradiotherapy

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Induction chemotherapy

Intervention Description

3 cycles, each 21 days, of Cisplatin 80mg/m2 plus Paclitaxel 175mg/m2

Intervention Type

Combination Product

Intervention Name(s)

Chemoradiotherapy

Intervention Description

Radiotherapy 70Gy convencional fractionation concomitant to 3 cycles, each 21 days, of Cisplatin 100mg/m2

Primary Outcome Measure Information:

Title

3-years overall survival

Time Frame

From date of randomization until 3 years

Secondary Outcome Measure Information:

Title

Progression free survival

Description

PFS

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

Title

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

Title

Overall survival

Time Frame

From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months

Title

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

Title

Adverse Events Rates

Time Frame

At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 21 days).

Title

1-year functional organ preservation rate

Time Frame

From date of randomization until 1 year after

Title

Quality of Life (EORTC Quality of Life Questionnare - C30 version 3.0)

Description

Time Frame

From date of randomization until 5 years

Title

Overall response rate to induction chemotherapy

Time Frame

At the end of Cycle 3 (each cycle is 21 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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;

Facility Information:

Facility Name

Barretos Cancer Hospital

City

Barretos

State/Province

São Paulo

ZIP/Postal Code

14784-400

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pedro De Marchi, MD, MSc

Phone

+55 17 33216600

Ext

6953

pedrodemarchi@yahoo.com.br

First Name & Middle Initial & Last Name & Degree

Raiany Carvalho, RN

Phone

+55 17 33216600

Ext

6712

raiany.carvalho@hcancerbarretos.com.br

First Name & Middle Initial & Last Name & Degree

Augusto E Mamere, MD, MSc

First Name & Middle Initial & Last Name & Degree

Alexandre A Jacinto, MD

First Name & Middle Initial & Last Name & Degree

Domingos Boldrini Junior, MD, MSc

First Name & Middle Initial & Last Name & Degree

Renato C Capuzzo, MD

First Name & Middle Initial & Last Name & Degree

Carlos R Santos, MD

First Name & Middle Initial & Last Name & Degree

Andre L Carvalho, MD, PhD

First Name & Middle Initial & Last Name & Degree

Luciano S Vianna, MD, PhD

First Name & Middle Initial & Last Name & Degree

Josiane D Mourão, MD

First Name & Middle Initial & Last Name & Degree

Ricardo R Gama, MD, PhD

First Name & Middle Initial & Last Name & Degree

Gustavo J Dix, MD, MSc

First Name & Middle Initial & Last Name & Degree

Diogo D Prado, MD

First Name & Middle Initial & Last Name & Degree

Pedro De Marchi, MD, MSc

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Induction Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

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