NCT02015650

Cetuximab Compared to Mitomycin-C and 5-Fluorouracil for Locally Advanced Squamous Cell Carcinomas of the Head and Neck

Randomized Phase IV Trial to Compare Cetuximab With Concomitant Radiation Therapy With Concomitant Mitomycin-C and 5-Fluorouracil With Radiation Therapy for Locally Advanced Squamous Cell Carcinomas of the Head and Neck

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Concomitant radio-chemotherapy has become a standard therapy for advanced squamous cell carcinomas of head and neck. Local side effects caused by chemotherapy, like mucositis, increase in combination with radiotherapy. Mucositis, as a painful inflammation and ulceration of the oral mucosa, limits patient´s treatment plan. Studies showed that one third of the patients discontinued Chemotherapy because of the side effects. Accordingly to these side effects, patients eating habits get limited. This requires an increase of pain medication, mostly an opioid derivate, which causes side effects too, which requires other symptomatic medication. This requires a change of nutrition from hard to pappy food and at further impairing, liquid food is needed. A central vein catheter has to be done for parental nutrition and a gastrostomy for enteral nutrition, which means risk of haemorrhage and increased risk of bacteraemias and sepsis for the patient. This would mean a decrease of general condition and a dose reduction or treatment stop is needed. Accordingly, the results are treatment delay and prolongation of hospital stay. Risk of the study will be the known side effects of the products: Mitomycin-C, 5-Fluorouracile, Cetuximab and radiation therapy. These are listed in the particular product description and the description of radiation thera-py. Another risk would be that the primary objective cannot be fulfilled. So the patients would have a lower quality of life than expected. Following benefits are expected. Benefit for patient: * Decrease of mucositis and side effects caused by mucositis, also xerostomia, taste disturbances, dietary restrictions, dysphagia * Decrease of pain medication and side effects caused by pain medication * Decrease of surgical intervention (gastric tube, central venous catheter) and risks caused by the interventions (sepsis, bacteraemia, bleeding, injury of heart and stomach, etc.) * Improving of patients social functioning, social eating, social contact * No interruptions of therapy * Increase of life quality * Weight stabilization Benefit for clinical practice: * Increase of compliance * Fulfilling of complete therapy * Hospital stays as planned

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
DRUG	Cetuximab	Patients in treatment group A will receive Cetuximab at a loading dose of 400 mg/m2 (administered over 120 minutes) and weekly maintenance doses of 250 mg/m2 (administered over 60 minutes) in combination with radiation therapy.
DRUG	Mitomycin-C/ 5-Fluorouracil	Patients in treatment group B will receive 7 weeks of radiation therapy concomitant with Mitomycin-C 10mg/m² (max. 15mg/m²) d 8 and d 43 and 5-Fluorouracil 1000mg/m²/24h (max. 1500mg/m²/24h) d 8 - 12 and d 43 - 47. Radiation therapy will begin on day 8.

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-04-19
• Completion: 2016-04-19
• First posted: 2013-12-19
• Last updated: 2020-05-18

Locations

1 site across 1 country: Austria