Induction Chemotherapy for Advanced Head and Neck Cancer

Barretos Cancer Hospital

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Radiation: Chemoradiotherapy (CRT); Drug: Induction TP chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00959387

Barretos-01

Details and patient eligibility

About

Over the last 30 years, induction chemotherapy (IC) has become important for the management of patients with locally advanced HNSCC (LAHNSCC), particularly since the introduction of taxanes. The results reported in the TAX 323 and TAX 324 trials indicate that the TPF regimen (docetaxel, cisplatin and 5-fluorouracil) improves overall survival comparing with the PF regimen (cisplatin and 5-fluorouracil), and the TPF regimen is globally the most accepted induction regimen for the treatment of LAHNSCC.

However, the TPF regimen has been associated with high toxicity rates, and patients frequently decline cisplatin during concurrent radiotherapy and require the use of infusion pumps and a central venous catheter.

Extensive efforts are ongoing to identify alternative schemes that are less toxic than the TPF regimen but are as effective for LAHNSCC and safely allow the use of definitive concurrent treatment based on cisplatin and radiotherapy.

Full description

This non-randomized phase II trial evaluated the safety, feasibility and response rates of concurrent therapy (cisplatin and radiotherapy) after three cycles of an IC regimen based on the combination of cisplatin plus paclitaxel without 5-fluorouracil (5FU) (thereby avoiding infusion pumps and a central venous catheter) in LAHNSCC patients with a high tumor burden.

The patients were stratified by tumor subsite (oropharynx and hypopharynx/larynx) and by tumor resectable status (resectable or irresectable advanced squamous cell).

Enrollment: 60 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed locally advanced squamous cell carcinoma of head and neck (stage III and IV) eligible to chemoradiotherapy.
• Presence of measurable disease
• ≥ 18 year
• ECOG performance status: 0-2
• Adequate bone marrow functions evidenced by: absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L and hemoglobin ≥ 90 g/L
• Adequate renal function.
• Adequate hepatic function.
• Patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the study.

Exclusion criteria

• Any previous chemotherapy or radiotherapy
• Patients who have known hypersensitivity to paclitaxel or cisplatin
• Patients who are receiving concurrent investigational, biological or immune therapies
• Concomitant administration of high doses of systemic corticosteroids
• Known HIV or Hepatitis B or C (active, previously treated or both; testing is not required)
• Uncontrolled CNS disease (e.g., seizures not controlled with standard medical therapy)
• Clinically significant cardiovascular disease.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Induction TP chemotherapy followed by CRT

Experimental group

Description:

paclitaxel 175mg/m2 as a 3-h infusion on Day 1, and cisplatin 80mg/m2 as a 2-h infusion on Day 1 three weekly followed by concurrent chemoradiotherapy based on cisplatin. All patient were given adequate hydration and antiemetics. All patients received supportive care during radiotherapy, including dietary measures, local antiseptics and laser therapy as preventive and curative support for oral mucositis.

Treatment:

Drug: Induction TP chemotherapy

Radiation: Chemoradiotherapy (CRT)