Induction Chemotherapy for Advanced Head and Neck Cancer

• Overall survival. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  It was defined as the time from histological diagnosis to death.
• Quality of life (EORTC QLQ-C30) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  Questionnaire of quality of life (EORTC QLQ-C30) was applied at baseline, before chemoradiotherapy and 60 days following last day of radiotherapy.
• Safety (by National Cancer Institute Common Toxicity Criteria) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  Adverse events (by National Cancer Institute Common Toxicity Criteria v3.0): Acute events (related to induction chemotherapy and related to chemoradiotherapy) and late events (during follow up)
• Progression-free survival. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  It was defined as the time from randomization to the first radiologic confirmation of disease progression.
• Laryngo-esophageal dysfunction-free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

• Overall survival defined as the time from randomization to death. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
• Quality of life (EORTC QLQ-C30) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
• Safety (by National Cancer Institute Common Toxicity Criteria) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
• Progression-free survival defined as the time from randomization to the first radiologic confirmation of disease progression or death from any cause within 60 days after the last assessment or randomization, whichever came first. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
• Laryngo-esophageal dysfunction-free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

The purpose of this study is to evaluate the response rate, safety, toxicity, and quality of life of paclitaxel and cisplatin induction chemotherapy. The trial will also evaluate overall survival, progression-free survival, locoregional control and laryngo-esophageal dysfunction-free survival.

A prospective unicenter phase-II trial will be performed to evaluate the effect of 3 cycles of IC with PC followed by concomitant CCRT in locally advanced SSCHN.

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

• Drug: Induction TP chemotherapy
  3 cycles of paclitaxel 175mg/m2 and cisplatin 80mg/m2 q3w.
  Other Names:

  • Paclitaxel
  • Cisplatin
• Drug: Induction TP chemotherapy
  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. All patients were given adequate hydration and antiemetics.

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.