None listed
Conditions
Brief summary
This study looks at the impact of TPF chemotherapy (combined Taxotere, Cisplatin and 5-Fluorouracil) on squamous cell (skin) cancer of the head and neck as measured by the oxygen levels in the tumour. Who is it for? You can join this study if you have locally advanced or locally recurring squamous cell carcinoma of the oral cavity or laryngeal region, which has not been previously treated. Trial details Participants will all receive treatment with TPF (combined Taxotere, Cisplatin and 5-Fluorouracil) chemotherapy followed by chemoradiation which is the standard treatment for locally advanced or locally recurrent head and neck cancer. The study aims to test whether chemotherapy with TPF gets rid of low oxygen levels in tumours as detected by FAZA PET imaging uptake (a way to measure oxygen levels in the tumour) prior to chemoradiation. FAZA uptake is measured prior to treatment and again after 3 cycles of TPF. The response rate to chemotherapy will also be assessed with a CT scan before and after chemotherapy and the response to chemoradiation will be determined by a FDG PET scan at the completion of treatment. The response to treatment will be correlated with the level of hypoxia in the tumour.
Interventions
-Taxotere, 75mg/m2 intravenous (IV) over 1 hour on day 1 of each cycle of TPF
-Cisplatin, 100mg/m2 Intravenous (IV) immediately after Taxotere on day 1 of each cycle of TPF
-5-Fluorouracil, 1000mg/m2 continuous infusion on days 1-4 of each cycle of TPF
- TPF chemotherapy will be given every 3 weeks for a total of 3 cycles
chemoradiation will comprise of radiation 70 Gy radiation in 35 Gy fractions given daily 5 days a week for 7 weeks.
cisplatin and 5-Fluorouracil will be administered in
-Taxotere, 75mg/m2 intravenous (IV) over 1 hour on day 1 of each cycle of TPF -Cisplatin, 100mg/m2 Intravenous (IV) immediately after Taxotere on day 1 of each cycle of TPF -5-Fluorouracil, 1000mg/m2 continuous infusion on days 1-4 of each cycle of TPF - TPF chemotherapy will be given every 3 weeks for a total of 3 cycles chemoradiation will comprise of radiation 70 Gy radiation in 35 Gy fractions given daily 5 days a week for 7 weeks. cisplatin and 5-Fluorouracil will be administered in weeks 1,4 & 7 of radiation only
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed