Induction Chemotherapy for Advanced Head and Neck Cancer

NCT00959387 | Completed Phase 2 DMC

• 1 other identifier: Barretos-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; induction chemotherapy

Outcome Measures

Primary Outcomes (1)

• Tumor response rate

  Tumor response was assessed after induction chemotherapy (just before chemoradiotherapy) and 6-8 weeks after completion of chemoradiotherapy. Evaluation of tumor response was by clinical examination, nasoendoscopy, and CT or MRI imaging of the primary site and the neck (RECIST criteria 1.1).

  At baseline, 2 weeks after the third cycle of IC and 6-8 weeks after the end of radiotherapy

Secondary Outcomes (4)

• Overall survival

  3 years

• Quality of life (EORTC QLQ-C30)

  2 years

• Adverse Events rate

  After every cycle of IC, after every cycle of concurrent chemetherapy and up to 8 weeks after the end of radiotherapy

• Progression-free survival.

  3 years

Study Arms (1)

Induction TP chemotherapy followed by CRT

EXPERIMENTAL

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.

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

Interventions

Induction TP chemotherapy 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.

Also known as: Paclitaxel, Cisplatin

Induction TP chemotherapy followed by CRT

Chemoradiotherapy (CRT) 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.

Also known as: Cisplatin, Radiotherapy, Concurrent chemoradiotherapy based on cisplatin

Induction TP chemotherapy followed by CRT

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Barretos Cancer Hospital

Barretos, São Paulo, 14784-400, Brazil

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Paclitaxel; Cisplatin; Chemoradiotherapy; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Luciano S Viana, MD, MSc, PhD

  Brazilian Society of Clinical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 3, 2009
• First Posted: August 14, 2009
• Study Start: August 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: April 1, 2013
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

BR (1)