A Phase 2 interventional study of Erbitux in Head and Neck Cancer Squamous Cell, sponsored by Groupe Oncologie Radiotherapie Tete et Cou. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-10-26.
Sponsored by Groupe Oncologie Radiotherapie Tete et Cou · Phase 2, Interventional, and Treatment
The purpose of this study is to investigate in patients with cancer of the throat and recurrent inoperable a different modality treatment consisting of radiation continuously for 5 weeks and half associated with a drug directed against a receptor on cell surfaces cancer, called Erbitux ®.
The investigators hope with this shorter treatment (1.5 weeks less than the usual treatment) to improve the antitumor efficacy without additional toxic side effects.
We hope with this treatment improved antitumor efficacy without additional toxic side effects, while being shorter than 1.5 weeks of standard therapy. But this is an hypothesis we can not meet the current state of knowledge, which justifies this study.
The main hypothesis is that this combination of reirradiation and Cetuximab give a relative gain of 15% complete response rate.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 50 is close to the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Groupe Oncologie Radiotherapie Tete et Cou is the lead sponsor of 32 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Radiotherapy during 5 weeks and concurrent Erbitux once a week.
Drug: Erbitux
To begin 7 days before radiotherapy, loading dose 400 mg / m² in the first week then 250 mg / m² weekly for the duration of radiotherapy (for a total of 7 doses including the loading dose)
The main objective is to evaluate the complete response rate of the association re-irradiation - Erbitux ®.
Time frame: It will be measured by spiral CT scan or magnetic resonance imaging (MRI), 2 months after the end of treatment
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Groupe Oncologie Radiotherapie Tete et Cou