Induction Chemotherapy for Advanced Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed 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).
    

Intervention name(s): Induction TP chemotherapy; Chemoradiotherapy (CRT)
Intervention type(s): Drug; Radiation
Intervention description(s): 3 cycles of paclitaxel 175mg/m2 and cisplatin 80mg/m2 q3w. All patients received supportive care during radiotherapy, including dietary measures, local antiseptics and laser therapy as preventive and curative support for oral mucositis.; Patients were treated with 2-dimensional radiation therapy planning (6MV photon beams). A combination of lateral-opposed portals, anterior and lateral wedged fields was used to treat the primary tumor and the lymph nodes. The primary tumor, macroscopically affected lymph nodes and bilateral cervical plus supraclavicular lymph chains were treated with five fractions of 2Gy per week for 5 weeks (up to a total of 50Gy). Gross tumor volume was defined as the primary gross tumor or involved node, and this measure was based on clinical, radiological and endoscopic examinations. An additional margin of 1.0cm was added to the GTV to create the CTV. A boost of five fractions of 2Gy per week for 2 additional weeks (up to a total dose of 70Gy) was prescribed to the CTV plus a margin of 1.0cm.
Other intervention name(s): Paclitaxel; Cisplatin; Cisplatin; Radiotherapy; Concurrent chemoradiotherapy based on cisplatin
Intervention MeSH terms: Paclitaxel; Cisplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: head and neck cancer; induction chemotherapy