Cetuximab Compared to Mitomycin-C and 5-Fluorouracil for Locally Advanced Squamous Cell Carcinomas of the Head and Neck
Status:
Terminated
Trial end date:
2016-04-19
Target enrollment:
Participant gender:
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