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

B

Barretos Cancer Hospital

Status and phase

Enrolling
Phase 3

Conditions

Locally Advanced Malignant Neoplasm

Treatments

Drug: Induction chemotherapy
Combination Product: Chemoradiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03815903
BarretoCH - 201801

Details and patient eligibility

About

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.

Enrollment

434 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

434 participants in 2 patient groups

A - induction chemotherapy
Active Comparator group
Treatment:
Combination Product: Chemoradiotherapy
Drug: Induction chemotherapy
B - chemoradiotherapy
Experimental group
Treatment:
Combination Product: Chemoradiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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