Induction Chemotherapy for Advanced Head and Neck Cancer

NCT ID: NCT00959387

Last Updated: 2014-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-04-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Induction TP chemotherapy followed by CRT

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.

Group Type: EXPERIMENTAL

Induction TP chemotherapy

Intervention Type: DRUG

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.

Chemoradiotherapy (CRT)

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Other Intervention Names

Paclitaxel; Cisplatin; Cisplatin; Radiotherapy; Concurrent chemoradiotherapy based on cisplatin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barretos Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Luciano de Souza Viana

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luciano S Viana, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Brazilian Society of Clinical Oncology

Locations

Barretos Cancer Hospital

Barretos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Barretos-01

Identifier Type: -

Identifier Source: org_study_id