NCT04356170

Trial Evaluating Adapted Chemotherapy in Patients With Squamous Carcinoma

A Phase II Randomized Trial, Non Comparative, Evaluating Chemotherapy Associated Cisplatin, 5-fluorouracil and Docetaxel at Adapted Doses in Patients With Locally Advanced Squamous Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacity of the combination of cisplatin-5-FU and docetaxel in adapted doses in term of response to treatment without toxicity .

Detailed description

After explaining the treatment modalities, having read and explained the information letter to them, patients who have signed the consent to participate in the trial and who meet the inclusion criteria will be enrolled and randomized in the trial .

Conditions

• Cancer of Head and Neck

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel 75 mg/m² administered at D1 of each cure, every 3 weeks by intravenous infusion in 1 hour
DRUG	Cisplatin	cisplatine 75 mg/m² administered at D1 of each cure, every 3 weeks by intravenous infusion in 1 hour
DRUG	Fluoro Uracil	750 mg/m²/j administered continuously at D1 to D5 of each cure, every 3 weeks by intravenous infusion ( so 120 hours)

Timeline

• Start date: 2021-02-04
• Primary completion: 2025-08-05
• Completion: 2025-08-05
• First posted: 2020-04-22
• Last updated: 2025-09-02

Locations

1 site across 1 country: France