The effect of Taxotere, Cisplatin and 5-Fluorouracil (TPF) induction chemotherapy on intratumoral hypoxia in advanced head and neck squamous cell cancer

Phase 3

Recruiting

• Conditions: advanced head and neck squamous cell cancer; Cancer - Head and neck

• Registration Number: ACTRN12609000642280
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Aged 18 years or older
- previously untreated squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
- Histologically or cytologically confirmed squamous cell carcinoma
- stage 3 or 4 disease
- adequate hematological, renal, hepatic and pulmonary function
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) criteria
- creatinine clearance > or = 60ml/min

Exclusion Criteria

- women who are pregnant or lactating
- previous radiotherapy to area to be treated
- prior diagnosis of cancer
- clinical evidence of metastatic disease
- pre existing motor or sensory neurotoxicity or neuropathy > or = grade 1
- clinically significant sensorineural hearing loss
- active uncontrolled infection
- unstable cardiac disease requirin treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified