Induction chemotherapy for advanced head and neck cancer
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
This study is testing if giving chemotherapy before radiation treatment can help people with advanced head and neck cancer live longer and have better outcomes than standard treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 434 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Barretos Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 1 site (Barretos, São Paulo) |
| Trial ID | NCT03815903 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of induction chemotherapy followed by chemoradiotherapy in patients with locally advanced head and neck squamous cell carcinoma. It aims to determine whether this treatment strategy can improve overall survival rates compared to standard approaches. Participants will receive induction chemotherapy before undergoing chemoradiotherapy, and their outcomes will be monitored to assess the impact of this combined treatment. The study focuses on patients with specific stages of cancer and measurable disease.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, or larynx, who are either resectable or unresectable and eligible for chemotherapy and radiotherapy.
Not a fit: Patients with early-stage head and neck cancer or those with non-squamous cell carcinoma types may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with advanced head and neck cancer.
How similar studies have performed: Other studies have explored similar induction chemotherapy approaches, showing promising results, but this specific combination is being evaluated for its unique impact.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Barretos, São Paulo
- Barretos Cancer Hospital — Barretos, São Paulo, Brazil (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.