NCT00959387

Induction Chemotherapy for Advanced Head and Neck Cancer

Induction Chemotherapy (IC) With Paclitaxel and Cisplatin (PC) Followed by Concomitant Chemoradiotherapy (CCRT) in Patient With Advanced Squamous Carcinoma of the Head and Neck (SSCHN).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Barretos Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Induction TP chemotherapy	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.
RADIATION	Chemoradiotherapy (CRT)	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.

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-11-01
• Completion: 2013-04-01
• First posted: 2009-08-14
• Last updated: 2014-03-26

Locations

1 site across 1 country: Brazil