Induction Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT03815903 | Unknown Phase 3

• 1 other identifier: BarretoCH - 201801
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 3-years overall survival

  From date of randomization until 3 years

Secondary Outcomes (8)

• 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

• Adverse Events Rates

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

Study Arms (2)

A - induction chemotherapy

ACTIVE COMPARATOR

Drug: Induction chemotherapy; Combination Product: Chemoradiotherapy

B - chemoradiotherapy

EXPERIMENTAL

Combination Product: Chemoradiotherapy

Interventions

Induction chemotherapy DRUG

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

A - induction chemotherapy

Chemoradiotherapy COMBINATION_PRODUCT

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

A - induction chemotherapy; B - chemoradiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Barretos Cancer Hospital

Barretos, São Paulo, 14784-400, Brazil

RECRUITING

MeSH Terms

Interventions

Induction Chemotherapy; Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Remission Induction; Combined Modality Therapy; Radiotherapy

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 24, 2019
• Study Start: December 19, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2025
• Last Updated: July 18, 2019

Record last verified: 2018-12

Locations

BR (1)