RecruitingPhase 3ACTRN12609000642280

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

A pilot study evaluating the impact of Taxotere, Cisplatin and 5-Fluorouracil (TPF) induction chemotherapy on intratumoral hypoxia in locoregionally advanced head and neck squamous cell cancer


Sponsor

Peter MacCallum Cancer Centre

Enrollment

25 participants

Start Date

Jan 1, 2010

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether chemotherapy given before radiation treatment for head and neck cancer reduces the low-oxygen areas (called hypoxia) inside tumours. Tumours with low oxygen levels are harder to treat with radiation. The chemotherapy regimen being tested (called TPF — Taxotere, Cisplatin, and 5-Fluorouracil) is the standard treatment for locally advanced head and neck squamous cell cancer. Researchers will use a special PET scan (FAZA PET) to measure oxygen levels in the tumour before and after chemotherapy to see if the treatment makes the tumour easier to treat with radiation. You may be eligible if: - You are 18 years of age or older - You have squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx that has not been previously treated - Your cancer is at Stage 3 or 4 - Your cancer has been confirmed by a tissue biopsy - Your general health and organ function are adequate (ECOG performance status 0–1) You may NOT be eligible if: - You are a woman who is pregnant or breastfeeding - You have had previous radiation treatment to the area - You have had a previous cancer diagnosis - There is evidence that the cancer has spread to other parts of the body - You have significant pre-existing nerve damage or hearing loss - You have unstable heart disease or an uncontrolled infection Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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, 1000m

-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


Locations(1)

VIC, Australia

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ACTRN12609000642280